indian pharmacopoeia

INDIAN PHARMACOPOEIA

MONOGRAPH DEVELOPMENT

INDIAN PHARMACOPOEIA MONOGRAPH DEVELOPMENT

Indian Pharmacopoeia Commission (IPC)

Vision The IPC is committed to the promotion of the highest standards for drugs for use in the prevention and treatment of diseases in human beings and animals keeping in view the special features of the pharmaceutical industry in India.


Objectives The overall objective has been the creation of a compilation of standards that reflect the state of the industry in the country and the production and testing capabilities of units varying in size from the small to the very big.

Special efforts have been made to safeguard the interests of the weaker sectors of the industry without compromising the safety and efficacy of the medicines included in the Indian Pharmacopoeia (IP).


Priority given to monographs of drugs included

in the National Essential Drugs List and their dosage

forms. Regular upgradation of monographs but consistent with

the level and degree of sophistication acceptable to the

majority of manufacturers. Harmonization of IP standards with international

acceptance criteria for drug quality


Quality Standards Neither high nor low A compromise between the desirable and the achievable Avoidance of sophisticated instrumentation or

methodology Recognition of the difficulties of the small- and medium-

sized units of the industry


Retention of simple tests where complicated methods offer no advantage

No compromise on limitation of toxic impurities Gradual tightening of standards over the years


Overall philosophy The Indian Pharmacopoeia is the official book of standards

and medicines produced in India must comply with the specified standards

Pharmacopoeial standards and acceptance criteria are set with the intention that they be used only as compliance requirements and not as requirements to guarantee total quality assurance


Pharmacopoeial standards are the minimum ones with which a manufacturer must comply before release of a product for sale or distribution

It is recognized that changes in quality may occur during storage and distribution and the pharmacopoeial requirements are set to define acceptable levels of change and to reject materials or products showing unacceptable levels


It is the responsibility of the manufacturer to ensure that the product is manufactured in accordance with current Good Manufacturing Practices and that sufficiently stringent limits of acceptance are applied at the time of release of a batch of material or product so that the compendial standards are met until the expiry date under the storage conditions specified


Pharmacopoeial requirements for drug substances have been drawn up to provide appropriate limits for potential impurities rather than to provide against all possible impurities and adulterants.

Material found to contain an impurity that cannot be detected by means of the prescribed tests is to be considered as not of pharmacopoeial quality if the nature or amount of the impurity found is not compatible with good manufacturing practices.


General considerations Specifications designed for licensing, for compliance by

manufacturers and for the guidance of suppliers, users and for those representing consumers

Specifications valid for the entire period of use claimed by the manufacturer for the product

As a corollary, the test methods of the pharmacopoeia are applicable for ascertaining compliance at any time during the shelf life of the article.

Test methods need to be robust because they are intended to be used in a wide range of laboratories.


Monograph Development Process Individual monographs are designed to be followed along

with the requirements of the General Notices of the Pharmacopoeia, to the general test methods (described in a separate volume of the compendium) and to other information given in the General Chapters.

A final assessment of the quality of an article is to be done on a total evaluation of compliance with all these requirements and not in relation to only the contents of individual monographs.


In the process of developing a monograph the requirements and recommendations of the drug licensing authorities are also taken into account.

Continuous dialogue with manufacturers and users is an integral part of the process.

Firming up of a monograph takes place only after comments on test methods and limits of acceptance are agreed to by users subject to, in some cases, approval by licensing authorities


Bulk Drug Substances Standards generally based on the methods of manufacture

used by the industry in the country However, the interests of the protection of the public are

kept in mind in deciding the appropriate level of control Types of tests for determining compliance are also related

to the quality requirement and sophistication of testing equipment


Normal Format

Description. Physical form of the material, whether hygroscopic, odour, if apparent and indication of polymorphism, if applicable

Identification Tests usually including infrared spectrometry, if appropriate

Non-specific purity tests, such as light absorption, optical rotation, sulphated ash etc


Impurities , both related substances and impurities that may be present as a result of the method of manufacture or from degradation on storage

Impurities other than related substances that may require control such as heavy metals, inorganic impurities, residues of solvents and reagents used during synthesis and purification

Other tests such as loss on drying or water Assay and limits for purity calculated on the anhydrous,

dried or solvent-free basis, as appropriate


To the extent possible, for assay, a robust and precise, though not specific method is given rather than a specific stability-indicating and complex one. With increasing emphasis on stability, the latter is often unavoidable

In the case of non-specific assay methods, control of impurities is provided separately by means of specific impurity tests.

Each monograph is designed to be considered as a whole and should provide a reliable basis for judging the quality of the drug substance.


Dosage Forms Monographs are designed to be read in conjunction with

the general monograph for the dosage form. The latter provides for the general requirements and any exceptions to, or modifications of, these requirements.

The applicability of the tests of a monograph must be ensured by the manufacturer by the proper choice of excipients and other pharmaceutical aids.

Limits for known impurities are given in many monographs but manufacturers are expected to also limit unknown impurities arising out of manufacture and storage.


Normal Format Description of the preparation in terms of the active

ingredient(s) and , where applicable, the manner in which it is presented

Additional specific information on the product is given in some cases e.g. for tablets, whether or not they are coated.

A statement of the limits of acceptance of the content in terms of percentage of the labelled content of the active ingredient. In many cases, the content is expressed in terms of the therapeutically active part of the molecule.


Identification tests based on those for the parent drug substance, where applicable, with suitable details for isolation of the active ingredient from the excipients.

Impurities as in the case of drug substances but additionally including those arising on manufacture or storage of the dosage form.

Carry-over of impurities from the drug substance used in the dosage form to be determined, wherever possible, with any necessary modification, to demonstrate that drug substance of pharmacopoeial quality had been used in the formulated product.


Assay methods, to the extent possible, are stability-indicating subject to the easy availability of the reference substance of the active ingredient(s)

Other tests such as pH, appearance of solution, dissolution test and for single-dose preparations, a test for uniformity of content may be specified.

In general, standards for a dosage form are expected to be indicative of the strength, stability and where applicable, the safety of the product


Test methods Generally provided by manufacturers and users and

expected to be suitable, validated, robust and reproducible. The method is applicable throughout the shelf-life of the

dosage form or throughout the period of use recommended by the manufacturer for a dug substance.

It is not expected that excipients used in a formulation interfere in the test and cause errors in testing or in the estimation of the active ingredient(s)


The results obtained by testing taken as a whole should enable an independent and correct judgement as to the quality of an article and to an assurance of compliance with the published standards.

Pharmacopoeial methods usually prescribe the use of testing equipment available to most manufacturers and public testing laboratories.

Test methods are described in a clear language and in sufficient detail that they can be followed in any laboratory by a trained analyst.


New methods and revisions to existing ones are evaluated by expert groups of the Scientific Body of the IPC and in many cases, verification is done by the laboratory of the IPC in consultation with the proposers of the methods.

Comments on the proposed or revised methods are invited before finalisation and inclusion in a monograph.

Notwithstanding the assurance that a method given in a monograph is valid, the user is expected to confirm that it is applicable to the particular material or product being examined.

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