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INDIAN PHARMACOPOEIA

MONOGRAPH DEVELOPMENT

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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.

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Objectives The overall objective has been the creation of acompilation of standards that reflect the state of theindustry in the country and the production and testingcapabilities of units varying in size from the small to thevery big.

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

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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

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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

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Retention of simple tests where complicated methods offerno advantage

No compromise on limitation of toxic impurities

Gradual tightening of standards over the years

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Overall philosophy

The Indian Pharmacopoeia is the official book of standardsand 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 compliancerequirements and not as requirements to guarantee total

quality assurance

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Pharmacopoeial standards are the minimum ones with

which a manufacturer must comply before release of aproduct 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

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It is the responsibility of the manufacturer to ensure that

the product is manufactured in accordance with currentGood 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

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Pharmacopoeial requirements for drug substances have

been drawn up to provide appropriate limits for potentialimpurities 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.

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General considerations

Specifications designed for licensing, for compliance bymanufacturers and for the guidance of suppliers, users andfor those representing consumers

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

As a corollary, the test methods of the pharmacopoeia are

applicable for ascertaining compliance at any time duringthe shelf life of the article.

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

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Monograph Development Process

Individual monographs are designed to be followed along

with the requirements of the General Notices of thePharmacopoeia, 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.

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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

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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 testingequipment

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Normal Format

Description. Physical form of the material, whetherhygroscopic, 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

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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

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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.

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Dosage Forms

Monographs are designed to be read in conjunction withthe general monograph for the dosage form. The latter

provides for the general requirements and any exceptionsto, or modifications of, these requirements.

The applicability of the tests of a monograph must beensured by the manufacturer by the proper choice ofexcipients and other pharmaceutical aids.

Limits for known impurities are given in manymonographs but manufacturers are expected to also limitunknown impurities arising out of manufacture andstorage.

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Normal Format

Description of the preparation in terms of the active

ingredient(s) and , where applicable, the manner in whichit 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.

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

Impurities as in the case of drug substances butadditionally including those arising on manufacture orstorage of the dosage form.

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

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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

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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)

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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.

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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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