Indian Pharmacopoeia
Indian Pharmacopoeia
Indian Pharmacopoeia
MONOGRAPH DEVELOPMENT
INDIAN PHARMACOPOEIA
MONOGRAPH DEVELOPMENT
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
INDIAN PHARMACOPOEIA
MONOGRAPH DEVELOPMENT
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
INDIAN PHARMACOPOEIA
MONOGRAPH DEVELOPMENT
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.
INDIAN PHARMACOPOEIA
MONOGRAPH DEVELOPMENT
Normal Format
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
pharmaceu tical 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.
st orage.
INDIAN PHARMACOPOEIA
MONOGRAPH DEVELOPMENT
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.
INDIAN PHARMACOPOEIA
MONOGRAPH DEVELOPMENT
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)
INDIAN PHARMACOPOEIA
MONOGRAPH DEVELOPMENT