This document discusses pharmacopoeias, which are official collections of standards for drugs that are published by national authorities. It provides information on the purpose of pharmacopoeias in controlling drug quality and ensuring public health. Several major pharmacopoeias are identified, including the Indian Pharmacopoeia, US Pharmacopoeia, and European Pharmacopoeia. The document also describes pharmacopoeial monographs, which provide standards for individual drug substances, and limit tests, which are used to control small amounts of impurities in drugs. As an example, the limit test for chloride is outlined, which uses silver nitrate to precipitate chloride ions and compare the sample to a standard solution.
2. Pharmacopoeia
Pharmacopoeia is the word derive from greek
word pharmakon means drug and poeia to make.
It is a legally binding collection, prepared by
national authority.
Pharmacopoeia is a book or encyclopaedia of
drug standards, their formulae, methods of
preparation, requirements and tests for their
purity and other related information.
It is a book containing an official list of
medicinal drugs together with article on their
preparation with their effects and direction of
use.
3. The purpose for publication of pharmacopoeia is
to control the quality of medicine as per
standards, to ensure the public health and to
support the availability of safe, effective good
quality of pharmaceutical.
Types of pharmacopoeia
1. Indian pharmacopoeia(IP)
2. United states pharmacopoeia(USP)
3. British pharmacopoeia(BP)
4. British pharmaceutical codex
5. European pharmacopoeia(EU)
6. Japanese pharmacopoeia(JP)
4. Pharmacopoeial monograph
A monograph is a written document or
standard that describe an item.
A monograph published in any official
pharmacopoeia provides the name of
substance, its definition, solubility,
package, storage, labelling requirement,
impurity and information on tests needed
to ensure substance of the appropriate
strength, quality and purity.
5. INDIAN PHARMACOPOEIA
Indian pharmacopoeia commission (IPC)
is an autonomous institution of the
ministry of health and family welfare
which sets standards for all drugs that are
manufactured, soled and consumed in
India.
The sets of standards are published under
the title Indian pharmacopoeia(IP)
6. BRITISH PHARMACOPOEIA
The British pharmacopoeia(BP) is the
national pharmacopoeia of the united
kingdom.
The British pharmacopoeia is an
important statutory component in the
control of medicine. Along with the
British national formulary(BNF) , it
defines the UK`s pharmaceutical
standards.
7. EUROPEAN PHARMACOPOEIA
The European pharmacopeia is a
pharmacopoeia that aims to provide
common quality standards throughout
Europe to control the quality of medicine
and the substances used to manufacture
them.
8. LIMIT TEST
Limit tests are quantitative or semi quantitative
tests especially set to control little amount of
impurities that should be present in
pharmaceutical substances.
Limit test for chloride
Principle – limit test for chloride is based on its
precipitation phenomenon. Chloride is
precipitated with silver nitrate(AgNO3) in the
presence of dilute nitric acid and comparing the
turbidity produced due to the formation of silver
chloride(AgCl) with a standard solution of
known quantity of chloride ions.
NaCl + AgNO3 AgCl +NaNO3
9. Methodology
1. Dissolve the weighed quantity of the sample
in distilled water and transfer to nessler
cylinder
2. Take 10 ml of 25 ppm chloride solution in
another nessler cylinder
3. Add 10 ml of dilute nitric acid and dilute
solution up to 50ml with distilled water and
finally DD 1ml of 0.1M silver nitrate
solution in both nessler cylinder.
4. Observe the opalescence of both by viewing
transversely against black background.
5. If opalescence of sample is less intense than
the standard chloride solution sample passes
the limit test for chloride.
