The Real Complexity of Excipient Composition

Since the United States Pharmacopeia (USP) and National Formulary (NF) General Notices combined, it could be interpreted that API requirements apply to excipients. [...]contaminants may be present (i.e., substances not directly resulting from the excipient manufacturing process [synthesis and/or pur...

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Bibliographic Details
Published in:Pharmaceutical Technology 2017-10, Vol.41 (10), p.54-63
Main Authors: Carlin, Brian, Collins, George, Herzog, Linda A, Moreton, R Christian, Schoneker, David, Walsh, Phyllis, Zawislak, Priscilla, Zeleznik, Joseph
Format: Magazinearticle
Language:English
Subjects:
By products
Descriptive labeling
Drug delivery systems
Good Manufacturing Practice
Ingredients
Manufacturers
Manufacturing
Pharmaceutical industry
Pharmaceuticals
Polyethylene glycol
Risk assessment
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Summary:Since the United States Pharmacopeia (USP) and National Formulary (NF) General Notices combined, it could be interpreted that API requirements apply to excipients. [...]contaminants may be present (i.e., substances not directly resulting from the excipient manufacturing process [synthesis and/or purification], but as a consequence of extraneous factors such as personnel, equipment, packaging, other products, etc.). The Glossary found in USP 40-NF 35 General Chapter Good Manufacturing Practices For Bulk Pharmaceutical Excipients defines an excipient as "Any substance, other than the active pharmaceutical ingredient or drug product, that has been appropriately evaluated for safety and is included in a drug delivery system to aid the processing of the drug delivery system during manufacture; to protect, support, or enhance stability, bioavailability, or patient acceptability; to assist in product identification; or to enhance any other attribute of the overall safety and effectiveness of the drug delivery system during storage or use" (7). According to General Notices 5.60.10 in USP 40-NF 35, "The presence of any unlabeled other impurity in an official substance is a variance from the standard if the content is 0.1% or greater.
ISSN:1543-2521
2150-7376