STANDARDIZATION OF PHARMACEUTICALS AND FORMULATED PRODUCTS:
The word standardization is derived from the word standard which implies to some major principle or
model with which things of the same class are compared in order to determine quality or value. In
pharmaceuticals standards are of two types:
* Standards which are given in the pharmacopeia in the form of monograph
* Standards which are framed by the manufacturer
OBJECTIVE OF STANDARDIZATION:
The prime objective of standardization is that the chemical substances or formulated products must be
clinically satisfactory this means it should be safe, effective and stable and it shouldn’t have any
unspecified variation in its amount and it is free from any toxicity or harmful effect.
STANDARDIZATION PROCESS:
In the standardization process various test and assay procedure are applied for the evaluation of raw
material, processed, intermediate and finished products so as to confirm these compliance with the
standard. For this it is necessary to have a good knowledge of the methods and procedure. As discussed
earlier that for standardization the substances or formulated product must adhere to the approved
standards and it is a possibility that two different types of standards may differ from one another and
therefore, it is necessary that certain variation limits are established. In the standardization process the
following are taken into account;
NATURE AND PURITY OF RAW MATERIALS AND FINISHED PRODUCTS:
The raw materials are standardize by ascertaining various characteristics these include purity, identity,
strength, and detection of contaminants, all of these are determined by melting pint, boiling point,
specific gravity, UV-visible spectrophotometry, NMR etc.
MANUFACTURING VARIATIONS:
As we know that different drugs are prepared by different manufacturer under different environmental
and physical conditions and therefore, it is necessary that there must be a minimum standard for a given
pharmaceutical formulation. Usually the percent error allowed is ± 5%.
HAZARDS OF STORAGE:
