Write a short note on sources of impurities in pharmaceutical substance
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SOURCES OF IMPURITIES
The various sources of impurities in pharmaceutical
substances are as follows:
1. Raw Materials Employed in the Manufacturing of the Pharmaceutical Substance
Pharmaceutical substances are either isolated from natural sources or synthesized from
chemical starting materials. The natural sources include mineral sources, plants, animals
and microbes. It is essential to verify the identity of the source material and to establish its
quality otherwise impurities associated with the raw materials may be carried through the
manufacturing process to contaminate the final product. In nature minerals rarely occurs in
a reasonably pure from. Almost always mixtures of closely related substances occur together
2. Method of Manufacture
The process or method of manufacture may introduce new impurities into the final product
arising due to contamination by reagents, catalysts and solvents employed at various stages
of the manufacturing process. The new impurities may also arise from the reaction vessels
and reaction intermediates.
(A
(iii) Contamination by microbes: Many products, like liquid preparations and
creams intended for topical applications are liable to contamination by microbes from the
atmosphere during manufacturing. For all products intended for parenteral administration
and ophthalmic preparations, sterility testing is done and it provides an adequate control for
microbial contaminations in such preparations. Microbial contamination can be controlled
by adding suitable antimicrobial and antifungal agents.
(iv) Errors in the manufacturing process: Sometimes in a liquid preparation,
there is incomplete solution of the solute. This ought to be detected by the normal analytical
methods as it can lead to major error. A proper check on the efficiency of mixing, filling,
tabletting, sterilization etc. should be exercised in order to obtain a product of maximum
purity and desired quality. Special precautions are required to be observed to avoid mixing
and filling errors in the preparation of low dosage forms (e ú 5 mg) such as tablets and
capsules containing highly potent medicaments
The various sources of impurities in pharmaceutical
substances are as follows:
1. Raw Materials Employed in the Manufacturing of the Pharmaceutical Substance
Pharmaceutical substances are either isolated from natural sources or synthesized from
chemical starting materials. The natural sources include mineral sources, plants, animals
and microbes. It is essential to verify the identity of the source material and to establish its
quality otherwise impurities associated with the raw materials may be carried through the
manufacturing process to contaminate the final product. In nature minerals rarely occurs in
a reasonably pure from. Almost always mixtures of closely related substances occur together
2. Method of Manufacture
The process or method of manufacture may introduce new impurities into the final product
arising due to contamination by reagents, catalysts and solvents employed at various stages
of the manufacturing process. The new impurities may also arise from the reaction vessels
and reaction intermediates.
(A
(iii) Contamination by microbes: Many products, like liquid preparations and
creams intended for topical applications are liable to contamination by microbes from the
atmosphere during manufacturing. For all products intended for parenteral administration
and ophthalmic preparations, sterility testing is done and it provides an adequate control for
microbial contaminations in such preparations. Microbial contamination can be controlled
by adding suitable antimicrobial and antifungal agents.
(iv) Errors in the manufacturing process: Sometimes in a liquid preparation,
there is incomplete solution of the solute. This ought to be detected by the normal analytical
methods as it can lead to major error. A proper check on the efficiency of mixing, filling,
tabletting, sterilization etc. should be exercised in order to obtain a product of maximum
purity and desired quality. Special precautions are required to be observed to avoid mixing
and filling errors in the preparation of low dosage forms (e ú 5 mg) such as tablets and
capsules containing highly potent medicaments
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explain about sources of impurities in pharmaceutical sustance
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