Evaluating impurities in drugs Part I

Evaluating impurities in drugs Part I

Impurity control in starting materials used to manufacture APIs has long been expected by regulatory agencies. An API starting material is a raw material, intermediate, or API that is used in the production of an API and that is incorporated as a significant structural element into the API. API star...

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Veröffentlicht in:Pharmaceutical technology Europe 2012-02, Vol.24 (2), p.15
Hauptverfasser: Wadekar, Kashyap R, Bhalme, Mitali, Rao, S Srinivasa, Reddy, K Vigneshwar, Kumar, L Sampath, Balasubrahmanyam, E
Format: Artikel
Sprache:eng
Schlagworte:
Analgesics
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Zusammenfassung:Impurity control in starting materials used to manufacture APIs has long been expected by regulatory agencies. An API starting material is a raw material, intermediate, or API that is used in the production of an API and that is incorporated as a significant structural element into the API. API starting materials normally have defined chemical properties and structure.
ISSN:1753-7967