Big Chemical Encyclopedia

Chemical substances, components, reactions, process design ...

Articles Figures Tables About

Excipient Selection and Criteria for Injectable Dosage Forms

Excipient Selection and Criteria for Injectable Dosage Forms [Pg.271]

Mahesh V. Chaubal, James Kipp, and Barrett Rabinow [Pg.271]

Excipients used in injectable formulations have to meet several stringent requirements. A positive identification test uniquely applicable to the excipients is required (e.g., infrared spectrophotometry and chromatography). It is important that manufacturers identify and set appropriate limits for impurities. These limits should be based upon appropriate toxicological data, or the limits described in national compendial requirements. Manufacturing processes should be adequately controlled so that the impurities do not exceed such established specifications. Solvents or catalysts used in the excipient production process should be removed to appropriate levels. If naturally derived, excipients should meet endotoxin levels and may require further testing for bovine spongiform encephalopathy (BSE) / [Pg.271]




SEARCH



Criteria for selection

Dosage and

Dosage forms selection criteria

Excipient

Excipient Selection

Excipients

Excipients selection

Select Criteria

Selection criteria

Selectivity criteria

© 2024 chempedia.info