an evidence-based guide is organised into four sections day to guide their clinical practice Herbs and Natural Suppleme. I.p. volume 2. 1. INDIAN PHARMACOPOEIA Volume 2 THE INDIAN PHARMACOPOEIA COMMISSION GHAZIABAD; 2. Volume 2. Mr. Debasish Panda from 2 April ) ix INDIAN PHARMACOPOEIA COMMISSION IP Member The Drugs Controller General (I), Member The Joint.

Indian Pharmacopoeia 2007 Volume 2 Pdf

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Volume 1. THE INDIAN PHARMACOPOEIA COMMISSION. GHAZIABAD Chapters. Volume 2 deals with the General Monographs on. Volume 3. INDIAN PHARMACOPOEIA CONTENTS. Monographs on Drug Substances, .. D. Dissolve g in 2 ml of hydrochloric acid and add ml. Volume 2. INDIAN PHARMACOPOEIA General Monographs on Dosage Forms. thereto, is Indian Pharmacopoeia , abbreviated to IP

Containers for multiple application preparations should permit the withdrawal of successive doses of the preparation. Such containers should normally hold not more than 10 ml.

During development of a formulation of ear drops containing an antimicrobial preservative, the need for and the efficacy of the chosen preservative shall be demonstrated by the test for efficacy of antimicrobial preservation 2.

During manufacture, packaging, storage and distribution of ear drops, suitable means shall be taken to ensure their microbial quality; acceptance criteria for microbial quality are given in Chapter 5. Such preparations should not contain antimicrobial preservatives and should be packed in single dose containers.

Production Sterile Ear Drops are prepared using methods designed to ensure their sterility and to avoid the introduction of contaminants and growth of micro-organisms. Methods of sterilisation that may be used in the manufacture of Ear Drops are described in Chapter 5.

Ear Drops that are solutions are practically clear and practically free from particles when examined under suitable conditions of visibility. Ear Drops that are suspensions may show a sediment that readily disperses when shaken.

The suspension remains sufficiently dispersed to enable the correct dose to be removed from the container. Tests Uniformity of volume. Particle size. This test is applicable only to Ear Drops that are suspensions. Introduce a suitable volume of the Ear Drops into a counting cell or onto a microscope slide, as appropriate.

Scan at least 50 representative fields. Where the label indicates that the Ear Drops are sterile, it complies with the test for sterility 2.

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Droppers supplied separately also comply with these tests. Remove the dropper out of the package using aseptic precautions and transfer it to a tube containing suitable culture medium so that it is completely immersed. Incubate and carry out the tests for sterility on the medium. Ear Drops should be packed in well-closed containers. If the preparation is sterile, store in sterile, tightly-closed, tamper-evident containers. Containers should be made from materials that do not cause deterioration of the preparation as a result of diffusion into or across the material of the container or by yielding foreign substances to the preparation.

The container and package of a single application preparation should be such as to maintain sterility of the contents and the applicator up to the time of use. Containers for multiple application preparations should be fitted with an integral dropper or with a screw cap made of suitable material incorporating a dropper and plastic or rubber teat.

Alternatively, such a cap assembly may be packed separately. The label states 1 the names and concentrations in percentages, or weight or volume per ml, of the active ingredient s ; 2 the names and concentrations of any added antioxidant, stabilising agent or antimicrobial preservative; 3 that, for multiple application containers, the contents should not be used for more than 1 month after opening the container; 4 that, for multiple application containers, care should be taken to avoid contamination of the contents during use; 5 that the preparation is NOT FOR INJECTION; 6 that, where applicable, the preparation is sterile; 7 the storage conditions.

Eye Drops Ophthalmic Drops Eye Drops are sterile, aqueous or oily solutions or suspensions of one or more medicaments intended for instillation into the conjunctival sac.

They may contain suitable auxiliary substances such as buffers, stabilising agents, solubilising agents and agents to adjust the tonicity or viscosity of the preparation.

However, if buffering agents are used in preparations intended for use in surgical procedures care should be taken to ensure that the nature and concentration of the selected agents are suitable. Where the active ingredient is susceptible to oxidative degradation, a suitable antioxidant may be added but care should be taken to ensure compatibility between the antioxidant and the other ingredients of the preparation.

Certain Eye Drops may be supplied in dry, sterile form to be constituted in an appropriate sterile liquid immediately before use. The antimicrobial preservatives should be compatible with the other ingredients of the preparation and should be effective throughout the period of use of the Eye Drops.

If the preparation does not contain an antimicrobial preservative it should be packed in single application containers. Eye Drops intended for use in surgical procedures should not contain antimicrobial preservatives and should be packed in single application containers. Eye Drops are prepared using methods designed to ensure their sterility and to avoid the introduction of contaminants and growth of micro-organisms.

Methods of sterilisation that may be used in the manufacture of Eye Drops are described in chapter 5. Eye Drops should be packed in tamper-evident containers. The container and package of a single dose preparation should be such as to maintain sterility of the contents and the applicator up to the time of use. Containers for multiple application preparations should be fitted with an integral dropper or with a sterile screw cap of suitable materials incorporating a dropper and plastic or rubber teat.

Alternatively, such a cap assembly may be packed separately after it is sterilised. Containers of multiple application preparations should permit the withdrawal of successive doses of the preparation. Eye Drops that are solutions are practically clear and practically free from particles when examined under suitable conditions of visibility. Eye Drops that are suspensions may show a sediment that readily disperses when shaken. This test is applicable only to Eye Drops that are suspensions.

Introduce a suitable volume of the Eye Drops into a counting cell or onto a microscope slide, as appropriate. Comply with the test for sterility 2. Incubate and carry out the test. Store in sterile containers sealed so as to protect from micro-organisms. The label states 1 the names and concentrations in percentages, or weight or volume per ml, of the active ingredients; 2 the names and concentrations of any added antimicrobial preservative; 3 that, for multiple application containers, the contents should not be used for more than 1 month after opening the container; 4 that, for multiple application containers, care should be taken to avoid contamination of the contents during use; 5 that the preparation is NOT FOR INJECTION; 6 the conditions under which the preparation should be stored.

Eye Ointments Ophthalmic Ointments Eye Ointments are sterile, semi-solid preparations of homogenous appearance intended for application to the eye. They may contain one or more medicaments dissolved or dispersed in a suitable basis.

Bases, which are usually non- aqueous, may contain suitable auxiliary substances such as stabilising agents, antimicrobial preservatives and antioxidants. The base selected must be non-irritant to the conjunctiva, allow the drug to diffuse throughout the secretions of the eye and retain the activity of the medicaments for a reasonable period of time under the stated conditions of storage.

Eye Ointments are prepared using methods designed to ensure their sterility and to avoid the introduction of contaminants and growth of micro-organisms. Methods of sterilisation that may be used in the manufacture of Eye Ointments are described in Chapter 5. Eye Ointments should be packed in small, sterilised collapsible tubes of metal or of suitable plastic fitted or provided with a nozzle of suitable shape to facilitate the application of the product without contamination and with a cap.

The content of such containers is not more that 5 g of the preparation. Eye Ointments may also be packed in single application containers of such a shape as to facilitate administration without contamination; such containers may be individually wrapped. Other requirements concerning containers are given in Chapter 6. Tests Uniformity of weight. Gently spread a small quantity of the Eye Ointment as a thin layer on a microscope slide.

Sterility 2. Comply with the test for sterility. Gels Gels are homogeneous, semi-solid preparations usually consisting of solutions or dispersions of one or more medicaments in suitable hydrophilic or hydrophobic bases.

GELS They are intended to be applied to the skin or certain mucous membranes for protective, prophylactic or therapeutic purposes. Gels may contain suitable added substances such as antioxidants, stabilisers and antimicrobial preservatives.

During manufacture, packaging, storage and distribution of gels, suitable means shall be taken to ensure their microbial quality; acceptance criteria for microbial quality are given in Chapter 5. Gels specifically intended for use on large open wounds or on severely injured skin should be sterile.

Gels should be packed in suitable well-closed or, if the preparation contains water or other volatile ingredients, suitable tightly-closed containers. The containers should be fitted with closures that minimise contamination with micro- organisms.

To the extent possible, collapsible tubes of suitable metal or plastic should be used. The label states 1 that the gel is sterile, where necessary; 2 the storage conditions. Gelslabelledassterilecomplywiththetestforsterility 2. Inhalation Preparations Inhalation Preparations are liquid or solid dosage forms intended for administration as vapours or aerosols to the lung in order to obtain a local or systemic effect.

They contain solutions or dispersions of one or more active ingredients which may be dissolved or dispersed in a suitable vehicle. Inhalation Preparations contain propellants, diluents, antimicrobial agents, solubilising and stabilising agents etc. They are available in single-dose or multidose containers.

Inhalation Preparations intended to be administered as aerosols dispersions of solid or liquid particles of active ingredient s in a gas are administered by pressurized metered-dose inhalers or by powder inhalers. Production Inhalation preparations should be manufactured in conditions designed to minimise microbial and particulate contamination. During the development of a preparation that contains an antimicrobial preservative, the effectiveness of the preservative selected, shall be determined as described in chapter 2.

The size of aerosol particles shall be controlled so that a significant fraction is deposited in the lung. In filling under pressure, the requisite volume of the concentrate of the active ingredient s is filled in the container and either the propellant is forced under pressure through the valve orifice after the valve is sealed, or the propellant is allowed to flow under the valve cap and the valve assembly is sealed.

In either case, the air in the container must be evacuated by means of vacuum or displacement with a small amount of the propellant. During production, strict control should be exercised by process controls that include propellant and medicament fill weights, pressure test and leak test of the finished product.

For preparations adversely affected by water present in quantities beyond certain limits, care should be taken to protect the products from moisture. Avoid storage under extremes of temperature and in an environment with undue fluctuations in temperature. The label states 1 the name s of the active ingredient s ; 2 the total amount of the active ingredient s in the container except in the case of metered-dose preparation for inhalation ; 3 that the container should be shaken before use; 4 the other instructions for use; 5 the date after which the preparation is not intended to be used; 6 the conditions under which it should be stored; 7 a warning that the container is under pressure and that it must not be punctured, broken or incinerated even when apparently empty; 8 the statement.

In the case of dry powder inhalers the label on the container states 1 the date after which the dry powder inhaler is not intended to be used; 2 the conditions under which the powder for Inhalation should be stored. Where the powder for Inhalation is supplied in a capsule, the label also states 3 the quantity of the active ingredient contained in each capsule; 4 that the capsules are intended for use in an inhaler and are not to be swallowed.

Information on use of the preparation provided in the pack shall include 1 the direction for correct use of the aerosol; 2 a warning that the container may explode if punctured, exposed to excessive heat or direct sunlight; 3 the directions for the disposal of the used or partly-used container. Pressurised Metered Dose Inhalers are dosage forms containing therapeutically active ingredients that are packaged under pressure in a sealed container and are released as a fine mist of spray upon activation of a suitable valve system.

The basic components of an aerosol system are the container, the propellant, the concentrate containing the active ingredient s , the valve and the actuator. Pressurised metered dose preparations are of two types, the two-phase system consisting of gas and liquid or the three- phase system consisting of gas, liquid and solid or liquid.

The two-phase preparation comprises a solution of active ingredient s in liquefied propellant and the vaporised propellant. The solvent is usually the propellant or a mixture of the propellant and co-solvents such as ethanol, propylene glycol and polyethylene glycols. The three-phase preparation consists of a suspension or emulsion of the active ingredient s and the vaporised propellants.

In the suspension the ingredient s may be dispersed in the propellant system with the aid of suitable pharmaceutical aids such as wetting agents, solubilising agents, emulsifying agents, suspending agents and lubricating agents to prevent clogging of valves. Active ingredients. For pressurised metered dose inhalations propellants perform the essential function of expelling the material from the container by supplying the necessary pressure within the aerosol system.

Indian pharmacopoeia 2007 volume 2 pdf

They are liquefied or compounded gases having vapour pressures exceeding atmospheric pressure. The commonly used propellants in aerosol systems are hydrocarbons, especially the fluorochloro- derivatives of methane and ethane, the butanes and pentanes and compressed gases such as nitrogen and carbon dioxide. Mixtures of propellants are often employed to obtain the necessary delivery and spray characteristics of the aerosol.

The valve regulates the flow of the active ingredient s and propellant from the container and determines the spray characteristics of the aerosol. It must be manufactured from materials which are inert to the contents of the aerosol.

The commonly used materials are rubber, plastic, aluminium and stainless steel. Products for oral or nasal inhalation require metered-dose valves which ensure delivery of a uniform quantity of spray and an accurate dose of the active ingredient s , both within specified tolerances, with each activation of the valve. Metered valves may need priming before use if the aerosol packages have not been stored properly or have not been used for long periods of time.

The actuator or adaptor which is fitted to the aerosol valve stem is a device which on depression or any other required movement opens the valve and directs the spray to the desired area. The design of the actuator which incorporates an orifice of varying size and shape and expansion chamber is very important in influencing the physical characteristics of the spray or foam, particularly in the case of inhalation aerosols, where the active ingredient s must be delivered in the proper particle size range.

A proportion of the active ingredient s is usually deposited on the inner surface of the actuator; the amount available is therefore less than the amount released by actuation of the valve. Aerosol containers are made of metal stainless steel, aluminum or tin-plated steel , glass or plastic or a combination of these materials.

The containers must be so designed that they provide the maximum in pressure safety and impact resistance. Tests Pressurised Metered-dose Preparations Contentofactiveingredientdeliveredperactuation. Apparatus A small sample vessel suitable for shaking.

The size of the vessel is such that when the aerosol is discharged into the specified volume of solvent under the conditions described in the Method below, the discharge takes place not less than 25 mm below the surface of the solvent. Astainless steel base plate with 3 legs and a central circular indentation with a hole about 1.

The arrangement should prevent particle entrapment and side-of- stem leakage during the delivery of the sample. Procedure Remove the pressurised container from the actuator and remove all labels and markings which may be present on the container with a suitable solvent. Dry the container, replace in its actuator, shake for about 30 seconds and holding it in an inverted position actuate the valve by discharging about 5 sprays to waste.

Remove the pressurised container from its actuator, clean the valve stem internally and externally and valve ferrule by washing with a suitable solvent. Dry the complete valve assembly using an air-supply line fitted with an appropriate narrow jet to ensure that all solvent is removed from the inside of the valve stem.

Wash the actuator after the initial discharge of 5 sprays to waste, with a suitable solvent and allow it to dry. Shake the pressurised container for about 30 seconds and place it inverted in the vessel. Discharge 10 deliveries below the surface of the solvent actuating the valve at intervals of not less than 5 seconds, maintaining the pressurised container in the vertical plane and discharging the aerosol through the hole in the centre of the base plate.

With some preparations it may be necessary to shake the pressurised container between each actuation of the valve; in such cases shaking should be carried out without removing the pressurised container from its inverted position in the vessel.

Remove the pressurised container, wash it with the specified solvent and dilute the combined solution and washings to the volume specified in the monograph. Determine the amount of active ingredient by the method described under Assay in the individual monograph This amount of active ingredient is referred as metered dose assay A for metered dose inhalers.

Fit the washed and dried actuator to the pressurised container and actuate the valve 10 times at intervals of not less than 5 seconds. Remove the actuator carefully from the pressurised container and wash it with small quantities of the specified solvent or solvent mixture.


This amount of active ingredient is referred to as actuator retention B for metered dose inhalers. Calculate the content of active ingredient delivered per actuation from the expression A— B. Uniformityofdelivereddose The delivered dose is the dose delivered from the inhaler to the patient.

For some preparations, the dose has been established as a metered dose. The metered dose is determined by adding the amount deposited on the inhaler device to the delivered dose. It may also be determined directly. The test is applicable to inhalation preparations containing the drug formulation e. Apparatus Most of the containers usually operate in a valve-down position. For those containers that operate in a valve-up position, an equivalent test is applied using methods that ensure the complete collection of the delivered dose.

For all the cases, prepare the inhaler as directed in the instructions to the patient and connect to a dose collection apparatus, which must be capable of quantitatively capturing the delivered dose see Fig. The apparatus consists of a filter-support base with an open- mesh filter-support, such as a stainless steel screen, a sample collection tube that is clamped or screwed to the filter-support base, and a mouthpiece adapter to ensure an airtight seal between the sample collection tube and the mouthpiece.

Use a mouthpiece adapter which ensures that the front face of the inhaler mouthpiece fits with the front face or the 2. The vacuum connector is connected to a system comprising a vacuum source and a flow regulator. The source should be adjusted to draw air through the complete assembly, including the filter and the inhaler to be tested, at Air should be drawn continuously through the apparatus to avoid loss of the active substance into the atmosphere.

The filter-support base is designed to accommodate 25 mm diameter filter disks. The filter disk and other materials used in the construction of the apparatus must be compatible with the active substance and solvents that are used to extract the active substance from the filter. One end of the collection tube is designed to hold the filter disk tightly against the filter-support base.

When assembled, the joints between the components of the apparatus are airtight so that when a vacuum is applied to the base of the filter, all of the air drawn through the collection tube passes through the inhaler.

Procedure Unless otherwise prescribed in the instructions to the patient, shake the inhaler for 5 seconds and discharge one delivery to waste.

Attach the inverted inhaler to the apparatus, depressing the valve for a sufficient time to ensure complete discharge. Repeat the procedure until the number of deliveries that constitute the minimum recommended dose have been sampled. Quantitatively collect the contents of the apparatus and determine the amount of active substance.

Repeat the procedure for a further 2 doses. Collect 4 doses using the procedure described above. Discharge the device to waste, waiting not less than 5 seconds between actuations until 3 doses remain.

Collect these 3 doses using the procedure described above. Acceptance criteria Unless otherwise justified and authorised, the preparation complies with the test if 9 out of 10 results lie between 75 per Fig.

If 2 or 3 values lie outside the limits of 75 per cent to per cent, repeat the test for 2 more inhalers. Not more than 3 of the 30 values lie outside the limits of 75 per cent to per cent and no value lies outside the limits of 65 per cent to per cent. Filter all solvents through an appropriately sized filter before use. Assemble a suitable membrane filtration apparatus.

Use a filter holder fitted with an input chamber designed to prevent any loss of material when the actuator mouthpiece of the aerosol is inserted and the valve actuated. Before assembly wash all parts of the membrane filter holder with water and methanol and dry in a stream of nitrogen or allow to dry in a laminar flow cabinet.

Remove the pressurised container and dry the membrane filter. Examine its entire filtering surface microscopically using a magnification of not less than x Number of deliveries per container. Take the pressurised container used in the test for Particle size and discharge the remaining contents to waste, actuating the valve at intervals of not less than 5 seconds. Record the number of deliveries discharged. The total number of deliveries so discharged in the test for Particle size is not less than the number stated on the label.

Leak test.

Select 12 pressurised containers at random, and record the date and time to the nearest half-hour. Weigh each container to the nearest mg, and record the weight, in mg, of each as W1.

Allow the container to stand in an upright position at room temperature for not less than 3 days, and again weigh each container, recording the weight, in mg, of each as W2 and recording the date and time to the nearest half-hour.

Determine the time, T, in hours, during which the containers were under test. Empty the contents of each container tested by chilling to reduce the internal pressure, removing the valve and pouring. Remove any residual contents by rinsing with suitable solvents, then rinse with a few portions of methanol.

Cool, weigh and record the weight as W3, and determine the net fill weight W1-W3 for each container tested. The requirements are met if the average leakage rate of the 12 containers is not more than 3. If 1 container leaks more than 5. Not more than 2 of the 36 containers leak more than 7. Where the net fill weight is less than 15 g the requirements are met if the average leakage rate of the 12 containers is not more than mg per year and none of the container leaks more than mg per year.

If 1 container leaks more than mg per year but not more than 1. Not more than 2 of the 36 containers leak more than mg per year and none of the 36 containers leaks more than 1. Deposition of the emitted dose The deposition of the emitted dose is a measure of the drug deposition during inhalation. This test is used to determine the fine particle characteristics of the aerosol clouds generated by preparations for inhalation and may be expected to correlate with the drug dose or that fraction of the drug dose that penetrates the lung during inhalation.

Individual monographs may also define the emitted fractions of the delivered dose in more than one particle size range.

Stage Mensuration. Manufacturers of cascade impaction devices provide a definitive calibration for the separation characteristics of each impaction stage in terms of the relationship between the stage collection efficiency and the aerodynamic diameter of particles and droplets passing through it as an aerosol. Calibration is a property of the jet dimensions, the spatial arrangement of the jet and its collection surface, and the airflow rate passing through it. This process, known as stage mensuration, replaces the need for repetitive calibration using standard aerosols and ensures that only devices that conform to specifications are used for testing inhaler output.

The process involves the measurement and adjustment of the critical dimensions of the instrument. Re-entrainment for apparatus B. Plate coating must be part of method validation and may be omitted where justified and authorised.

Mass balance. The total mass of the active substance is not less than 75 per cent and not more than per cent of the average delivered dose determined during testing for uniformity of delivered dose. This is not a test of the inhaler but it serves to ensure that the results are valid. Unless otherwise specified, one of the following apparatus and test procedures is used. Glass impinger The apparatus is shown in Fig.

Procedure Place the actuator adapter in position at the end of the throat so that the mouthpiece end of the actuator, when inserted to a depth of about 10 mm, lines up along the horizontal axis of the throat and the open end of the actuator, which accepts the pressurised container, is uppermost and in the same vertical plane as the rest of the apparatus.

Introduce 7 ml and 30 ml of a suitable solvent into the upper and lower impingement chambers, respectively. Connect all the component parts. Ensure that the assembly is vertical and adequately supported and that the lower jet-spacer peg of the lower jet assembly just touches the bottom of the lower impingement chamber. Connect a suitable pump to the outlet of the apparatus. Prime the metering valve by shaking for 5 seconds and discharging once to waste; after not less than 5 seconds, shake and discharge again to waste.

Repeat for further 3 times. Vijay Kumar Reddy Mr. Mahendran Mrs. Agrawal Ms. Narayana Reddy Mr. Desai Mr. Satish R. Gupta Mr. Koshti Dr. Juneja Dr. Mehta Mr. Arun Kumar Bana Mr. Venkat Reddy Mr. Intkhab Alam Ms. Raghuram Mr. Nagarkar Mr.

Sunil Raj Dr. Shiv Prasad Mr. Smita Ainapure Mr. Naresh Soni Dr. Naveen Kumar Mr.

Celine D'souza Mr. Mishra Mr. Brijesh Chandra Gautam Mrs. Bedi Dr. Rajan R. Chauby Dr. Hemal Patel Mrs. Vijay Chauhan Mr. Tahlan Mr. ChandrakantDhakrak Mr. Doshi Mrs. Wani Dr. Kiran Muzumdar Mr. Mone VJ Mr. Vmay Tiwari Dr. Sanjay Kumar Dr. Piyush Joshi Ms. Ananthakrishna Padiya Mr. Lalit Shah Ms. Rachna Kumria Dr.

Sameer Bhargava Dr. Ved Dr. Rajan Mr. Amit Mandal Mr. Surekha V. Arona Mane Mr. Dinesh Kumar Mr. Tiwari Mr. Geeta Amin Mr. Naresh Kumar Sharma Mr. Sheetal S. Praduya Deshmukh Mr. Nasa Dr. Juggnu Bhatt Dr. Veerramani Mr. Vmay Pathak Mrs. Ramkrishnan Mr.

Krishnendu Singh Ms. RashIDi Srivastava Mr. Ramesh Raghavendra Rao Dr.

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Udupa Mr. Ashish Suthar Dr. Sreedhar Khandavali Dr. Manjrekar Mr. Mahendra Durgavale Prof. Jain Dr. Nivedita N. Raut Mr. Chintan S. Sunil S.

Praful Lahorkar Mr. Ragho G. Natarajan Mr. SumantBaukhandi Mr. Koshia Mr. Sanjeev Wadhwa Mr. Mantri Mr. Dubal Mr. Karnlakar Sharma Dr. Trivedi Dr. DeepakRanch Mr. Keshor Pant Mr. Ajay Singh Mr. Amaljit Singh Mr. Pharmacopoeia ofJapan. Malkhan Singh in successfully Laboratories. Acknowledgements In preparing the sixth edition of the Indian Pharmacopoeia Ma. Nitya Anand have put or to the authorities issuing them.

Unichem Mr. Central Drugs valuable and enthusiastic assistance in preparing this edition. The scientific inputs by way of the co"operation and co- New Delhi. Chandru Sahani of Clenzaids for time to time is noteworthy.

Arbro Pharmaceutical Ltd. Bee is a source of immense inspiration and in his personal capacity Pharma Laboratories. Indian Immunological Ltd. Davinder Kapoor. Ranbaxy Research motivated one and a. Pharmacopoeia Laboratory. Organisation of Dr NityaAnand. The Commission expresses its gratitude to Mr.. Special mention is being made of the permission granted at the time ofpreparing the preceding edition by the Controller ofHer The Commission wishes to record its deep appreciation of the Majesty's Stationery Office HMSO.

Central Drugs Testing Laboratory. Ghaziabad from reference materials the United States Pharmacopoeia. Central Research Institute. Mumbai and the Indian Central Drugs The Commission is greatly indebted to the members of the Laboratory. Cipla Ltd. Brahrni and Mr. Joint Secretary HR and Mr. Arbro Pharmaceuticals Ltd. Kaushal Kishore. Torrent Research Centre. Ahmedabad and the Panda. These include the Indian Pharmacopoeia Laboratory. Hindustan Unilever Ltd.

Kapoor along with his associate Mr. Natural Remedies Pvt. Shiv Kumar Marhkan. Baxter India Pvt. At the same time. Secretary R for their interest shown on this publication. All India Institute of Medical Sciences. Special thanks to Dr.

Infra-red Reference Spectra ofother particularly Mr. Conventions and other gratefully acknowledged. Supriya Gupta.

Scientific Body.. Sanjeev way attributable to any of the publications mentioned above Garg under overa.. The Indian Commission. Debasish Bangalore. Indian Veterinary Research Institute. Anticancer drugs. General of the Pharmacopoeia should be done in the context of the Monographs on Dosage Forms. The test for pyrogens involving the use of animals has been virtually eliminated. It is essential that sufficiently stringent limits are applied at the time ofrelease of Presentation a batch of a drug substance or drug product so that the The Indian Pharmacopoeia is presented in three volumes.

Herbal products and identification has been continued. Volume II contains the General Notice. A and in particular. Monographs on drug monograph as a whole. Most of the Liposomal Amphotericin B injection is an added advantage in existing Assays and Related substances tests are upgraded view of latest technology adopted for drug delivery.

A by liquid chromatography method in view to have more chapter on NMR is incorporated in Appendices. The number of monographs of concept of relying on published infrared spectra as a basis for Excipients.

The test for bacterialendotoxins introduced in the previous edition is now applicable to more Fonnat items. Biotechnology products and Veterinary products. Standards for new drugs and drugs used General chemical tests for identification of an article have been under National Health Programmes are added and the almost eliminated and the more specific infrared and ultraviolet drugs as well as their formulations not in use nowadays are spectrophotometric tests have been given emphasis.

Changes The scope of the Pharmacopoeia has been extended to include Keeping in view the essential requirement under the Drugs products of biotechnology. The use of chromatographic methods has been greatly Monographs of Vaccines and Immunosera are also upgraded extended to cope with the need for more specificity in assays in view of development of latest technology in the field.

Herbs and Herbal products. This new edition of the Indian Pharmacopoeia entitled 6th Basis of Pharmacopoeial Requirements edition Indian Pharmacopoeia is published by the Indian As in the past. The specificity and to harmonise with other International chapter on microbial contamination is also updated to a Pharmacopoeias. Antiretroviral drugs have been increased in this edition.

The omitted from this edition. The standards laid down It supersedes the edition but any monograph of the earlier represent the minimum with which the article must comply edition that does not figure in this edition continues to be and it is inculcate on the manufacturer to ensure that the official as stipulated in the Second Schedule of the Drugs and article is manufactured in accordance with the Good Cosmetics Act.

Cross-referencing has been avoided to make General Chapters each monograph complete in itself thus making it convenient Volume I is devoted mainly to test methods that are applicable to the analyst.

Blood and blood-related products. The test for abnormal toxicity is now confined to certain In an effort to make the pharmacopoeia more user-friendly. Manufacturing Practices GMPs. Clindamycin Capsules xviii. Bifonazole Cream dosage forms.

Betamethasone Lotion In view of considering the microbiological quality. Anastrozole Tablets The chapter on Vaccines: General requirements has been Anhydrous Lactose updated. For the fIrst time in this chapter BumetanideInjection the analysis of strain Shigella boydii has been introduced Bumetanide Oral solution which is possibly not available in other Pharmacopoeias.

Analytical methods are. Monographs for other Chymotrypsin articles of a special nature such as vaccines and irnmunosera for human use. Special emphasis has been given on Capecitabine Tablets monoclonal antibodies Antisera.

Calcium Chloride Injection The chapter on biotechnology derived therapeutic products Capecitabine has been fully revised. Wherever appropriate. Tests for extraneous agents Atazanavir Capsules in seed lot. A list of new monographs items not included in the It also includes reference data such as reference spectra.

Minor corrections have been made in the appendices Artesunate entitled Tests onChicken flocks free from specified pathogens for the production and quality control of vaccines and General Atazanavir Sulphate provisions: Avian viral vaccines. The test methods reflect the but added in this edition is given below: Monographs on drug substances.

Homatropine MetIlylbrofuide 1ablets"". Live xx. Powder for Inhalation Secnidazole Diphtheria. Pertussis Whole Cell.

Live Sulphadimidine Omissions. Aclmowledgements xv Introduction xvii General Chapters 7 5. Tests on Blood and Blood-related Products 3. General Tests 6. General Notices 9 2. Tests on Vaccines 2. Pharmaceutical Methods 2. Biological Methods 25 2. Physical and Physicochemical Methods 2. Containers 7. Tables 7. Reference Data 4. Test Methods 17 2. Chemical Methods 69 2. Reagents and Solutions 5. Apparatus 19 2.

Tests on Herbal Products 2. All statements to it by the manufacturer. IP 1. The freedom to the manufacturers to add auxiliary used in this Pharmacopoeia or with reference thereto.

Automated An official preparation is a drug product dosageform and is procedures utilising the same basic chemistry as the test the finished or partially finished preparation or product of one procedures given in the monograph may also be used to or more official substances formulated for use on the patient.

The word 'official' wherever organisms. General Statements excipients pharmaceutical aids. An article is an item for which a monograph is provided. An official substance. Particular care should be taken to ensure that such substances are free from harmful Official and Official Articles.

In the event of doubt or dispute. Such mention to the contrary. Such alternative or automated procedures must be validated. The active pharmaceutical ingredients drug substances. The designation IP in conjunction with the the innocuity of such substances. The full name or title of this book. An article responsibility for assigning the period of validity shall be is not of pharmacopoeial quality unless it complies with all of with the manufacturer. The requirements stated in the obtained by the procedure given in this Pharmacopoeia is monographs apply to articles that are intended for medicinal conclusive.

Alternative methods of analysis monographs are provided are to be distinguished. The tests and assays described are the article purports to comply with IP standards. Added Substances. FresWy prepared.

Such an upper limit applies to the suitable desiccant. The term "alcohol" without qualification means ethanol 95 per cent. Unless otherwise stated. The term 'distilled water' indicates Purified Water prepared by Usually.

Other methods of heating may be final solution. Relative Density. The following expressions in issued for' use. The term 'distilled water' When the concentration of a solution is expressedas. Iodine Value. The water used complies the number of inmilitres of substance in grams of with the requirements of the monograph on Purified Water. Where the name of the solvent is not stated. Where the content of a substance is solution. For example. Where the result of an assay or test is required to be calculated Ethanol.

Not more than. Other dilutions of ethanol are indicated final product. A tightly-closed container of suitable size and Where the content of a substance is expressed in terms of the design that maintains an atmosphere of low moisture content chemical formula for that substance an upper limit exceeding by means of silica gel or phosphorus pentoxideor other per cent may be stated.

The symbol '0' used without qualification as percentage volume in volume. Made not more than 24 hours before it is Expression of Concentrations. Abbreviated Statements. Two consecutive 'contains not less than If the tenn is used without qualification it means Purified Water of the Pharmacopoeia. A bath of boiling water unless water at another as parts by weight g ofa' gas in parts by weight g of the temperature is indicated.

Any printed packing material. The term "ethanol" without qu! Pification means with reference to the dried. A quantity not exceeding 0. When the concentration of a solution is expressed in molarity designated by the symbol M preceded by a number.. The main titles of drug products are the ones commonly except where a preamble limits the application.

The opening statement of a monograph is one monographs for those individual ingredients for which that constitutes an official definition of the substance.

The atomic weight or than those included in the statement. Any ingredient s other Atomic and Molecular Weights. The opening definitive incorporated in a trivial name that appears on an IUPAC statement in certain monographs for drug products is given in preferred list.

It is for the licensing authority to statement of purity and strength and in descriptions of verify that the instructions have been followed. Synonyms drawn from the full non- requirements are not necessarily comprehensive for a given proprietary name of the active ingredient or ingredients have specific preparation. Subsidiary names and synonyms have also been General monographs on dosage forms include requirements given in some cases.

Monographs Titles. The stereochemistry. Statements given under the heading Production is based on the full name of the active ingredient. This information refers to the either on selected batches or on each batch prior to release. When the chemical structure ofan official for example. Chemical Fonnulae. Where the absolute stereochemical configuration is specified. All measures are not interfere with the tests and assays of the Pharmacopoeia. Graduated glass apparatus used in analytical Individual Monographs operations shall comply with the requirements stated in Chapter 2.

An apply equally to veterinary products as well. The recognised in practice. The atomic and the Pharmacopoeial requirements. The metric system of weights and in the therapeutic efficacy of the active ingredients and shall measures is employed in the Pharmacopoeia.

Any substance added in preparing an official specified are the applicable limits. Certain pharmaceutical substances and other articles are defined by reference to a particular method ofmanufacture. Doses mentioned in the Pharmacopoeia are intended spectrum should be achieved.

It generally are given. The statements under the heading Description exposure to direct sunlight or other strong light. A Test Methods statement that a substance or article is prepared or obtained by a certain method constitutes part of the official defInition References to general methods of testing are indicated by test and implies that other methods are not permitted.

Assurance of quality must be preparation given in the individual monograph indicates the ensured by the manufacturer by the use of statistically valid strength s usually marketed for information of the pharmacist sampling and testing programmes. Where a are not to be interpreted. In certain monographs for pharmaceutical Solubility. In the case of found is incompatible with gOQd pharmaceutical practice. In the case of When tests for infrared absorption are applied to material pharmaceutical aids it may indicate the more common usage extracted from formulated preparations.

The statement of category is provided for information and is indicative of the medical or pharmaceutical. A statement method numbers in brackets immediately after the heading of that a substance may be prepared or obtained by a.

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The limits of content stated are those identity. The statement is not intended to limit in any way with the specifIed reference spectrum may not always be the choice or use of the article nor to indicate that it has no possible. The tests and assays are the official methods upon which the They are not to be regarded as binding upon the prescribers.

In monographs on vegetable drugs. Statements on solubility are given in Chapter 2. It does not imply that a strength other than the one s mentioned in the individual monograph Tests. Tests and assays are prescribed for the minimum sample available on which the attributes of the Usual Strength. If it is usual to administer a Material found to contain such an impurity is not of drug by a method other than by mouth.

In certain monographs alternative series ofidentifIcation tests basis for recognition in the Pharmacopoeia. The requirements The medical practitioner will exercise his own judgment and are not framed to take into account all possible impurities.

They provide a means of verifying that the identity determined by the method described under Assay. The statement on the usual strength s of a article should be measured. It is act on his own responsibility in respect of the amount of any not to be presumed.

The tests given under the heading IdentifIcation and does not imply that other methods are not permissible. The reagents required for the tests in terms of the active ingredient. Where it is directed to use a Limits. Volumes stated in microlitres are measured using a micropipette Reference spectra are published by the IPC and they are or microsyringe.

They are standardized against after the decimal point is a zero or ends in a zero. Certain monographs require the use under examination. The flask or a burette. In the monographs on dosage forms and certain monographs in the pharmacopoeia shall not be claimed to be preparations. The limits given are based on data obtained in normal 'general laboratory reagent grade of commerce' it is intended analytical practice.

Reagents standards to be used in cases of arbitration. Standards Working Standards may be used for routine analysis. This means that the quantity and assays of the Pharmacopoeia are defined in the various of the active ingredient expected to be present and the quantity chapters showing their nature. They are the official conditions. No further be used. For the measurement of volumes. For preparations other than those of fixed strength.

The stated on the label. Unless otherwise directed. Secondary are used in the prescribed amounts. Test Animals. For weighings. A specification for a definite size or type that will interfere with the test or the assay. Where the use of an indicator solution is mentioned requirements of the monograph.

In tests where IP Reference Substances. The amount actually for intended use as prescribed in the Pharmacopoeia and are used. Details The term 'analytical reagent grade of commerce' implies that of such tests are provided in the general monographs. Measuring and weighing devices and other test or an assay shall be healthy and are drawn from a uniform apparatus are described in the chapter entitled 'Apparatus for stock.

They take into account normal analytical that a chemically pure grade material. In determining compliance with a a recommendation.

Statements under the side-heading Storage constitute Storage Containers. The In certain cases. Do not freeze governed by the Drugs and Cosmetics Rules. The articles of the Pharmacopoeia are the chapter entitled Containers 6. Precautions that should be In general.

The requirements.

For the following terms: Tests on Blood and Blood-related Products Gas Detector Tubes 21 2. Nessler Cylinders 21 2. Thermometers 22 2. Continuous Extraction of Drugs 23 Ultraviolet Ray Lamps 22 2. This was followed by IP , which covered both the drugs of British Pharmacopoeia BP and indigenous drugs used in India, with a Supplement published in incorporating the vernacular names of indigenous drugs and plants. However, from the BP was made official in India. A Drugs Enquiry Committee appointed in by the government recommended the publication of a National Pharmacopoeia.

After independence, the Indian Pharmacopoeia Committee was constituted in for publication of IP as it main function. Which published the IP in , followed by a Supplement in The pharmacopoeia contained both western and traditional system drugs commonly used in India and the same policy continued while preparing the Pharmacopoeia of India and its Supplement There had been a phenomenal growth and development of the Indian Pharma industry since independence, especially from early , both in the range of Active Pharmaceutical Ingredients APIs and the dosage forms produced.

This, totally transformed the profile of the Indian Pharmaceuticals markets and Indian Pharma industry emerged as one of the important global suppliers of pharmaceutical products, both to the developed and developing countries. These developments posed major challenges for the IP to reflect the quality standards of the marketed drugs, which the subsequent editions of IP tried to address. In view of these rapid advances, it was decided to publish a new edition of the Pharmacopoeia and its Addenda at regular and shorter intervals for which the Indian Pharmacopoeia Committee was reconstituted in In the Pharmacopoeia of India , its Addenda and , inclusion of traditional system of drugs was limited.

In view of the continuing rapid increase in the range of drugs produced in India, are IP , its Addendum , Supplement for Veterinary Products and Addendum were published. The Addendum was published by the IPC which included a large number of antiretroviral drugs and raw plants commonly used in making medicinal products not covered by any other pharmacopoeias, which attracted much global attention.

The IP Committee decided to delete the obsolete or less used product monographs and added monographs based on the therapeutic merit, medical need and extent of use of such articles in the country. The Indian Pharmacopoeia Commission was established in year It provided systematic approach and practices for publication of IP containing new monographs with focus on those drugs and formulations that cover the National Health Care Programmes and the National Essential Medicines and Addendum to the IP containing 72 new monographs.

IP contained monographs on antiretroviral, anticancer, antituberculosis and herbal drugs. It further emphasized on biological monographs such as Vaccines, Immunosera for human use, Blood product, Biotechnological and veterinary Biological and non-biological preparations.

Addendum to the IP and also incorporated 52 new monographs. The feedback and inputs have been reviewed by the relevant Expert Committee to ensure the feasibility and practicability of the standards and methods revised. Public Review and Comment Process for standards development related to this edition of the Indian Pharmacopoeia has given special attention to incorporate comments from stakeholders. In order to make IP user friendly, the existing formatting pattern has been suitably revised.

The standards prescribed in this edition are encouraged to adhere with the concept of harmonization, keeping in view the technological status for manufacture and analysis of drugs and pharmaceuticals in the country without compromising with the quality of the products.

It strives to update the existing monographs as well as incorporating the new monographs of drug substances based on clinical use of medicines in India and improving their test protocols. The IP has been considerably revised and improved in respect of the requirements of monographs, appendices and testing protocols by introducing advanced technology. The contents of Appendices are by and large revised in consonance with those adopted internationally.

The monographs of special relevance diseases of this region have been given special attention. In additions, emphasis has been put to bring out harmonization in Appendices to establish a sound connection between individual monographs and the relevant appendices, so as to make this edition precise and well structured. Number of monographs and appendices are expanded further to incorporate the latest technological advancement and regulatory compliance. Constant efforts have been made to unify the National Drug Standards and to bring them in line with the International Standards progressively by addition of monographs of new drugs and adopting current methology.

This is the seventh edition of the Indian Pharmacopoea.In additions, emphasis has been put to bring out harmonization in Appendices to establish a sound connection between individual monographs and the relevant appendices, so as to make this edition precise and well structured.

The overall height is about mm. Raghuram Mr. Unless otherwise prescribed in the patient instructions, shake the inhaler for 5 seconds and discharge one delivery to waste. Rahul Pandit , Engineer Follow. The multiplicity of fonts in the texts that was feature of earlier editions has been done away with making it easier to read the contents and ensuring uniformity of presentation of the subject matter.

Official and Official Articles. The rate of reaction concentration of the viable organisms in each test preparation depends on the concentration of endotoxin, the pH and the is estimated based on the concentration of the microorganisms temperature.

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