Synthesis and Characterisation of Impurities of Manufacture in Support of Certificate of the European Pharmacopoeia Applications Part 1 (Clobetasone Butyrate)
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- 作者：Stephen McGhie ; Alan Sewell ; John Devlin ; Mark J. Wilson ; Lee Newton ; Kirsty McLaren ; Maranda Thomson ; Steven Cobb ; Jacqueline Ferguson ; and Kevin Prudhoe
- 刊名：Organic Process Research & Development
- 出版年：2003
- 出版时间：November 2003
- 年：2003
- 卷：7
- 期：6
- 页码：896 - 903
- 全文大小：136K
- 年卷期：v.7,no.6(November 2003)
- ISSN：1520-586X
文摘
Established pharmaceutical products often have complex supplychains and regulatory histories. In Europe the EuropeanDirectorate for the Quality of Medicine (EDQM) (informationfrom European Pharmacopoeia website, http://www.pheur.org/)have promoted the use of certificates of suitability of theEuropean Pharmacopoeia to ensure the quality of medicinesby a commonly recognised set of standards, allowing the freemovement of medicinal products in member states. Thiscontribution describes the analytical and synthetic chemistryrequired to synthesise the impurities of manufacture of clobetasone butyrate.