Analytical Method Development and Validation

Michael E. Swartz, Ira S. Krull (Herausgeber)

Buch | Hardcover

96 Seiten

2017
CRC Press (Verlag)
978-1-138-40256-0 (ISBN)

Infos

Describes analytical methods development, optimization and validation, and provides examples of successful methods development and validation in high-performance liquid chromatography (HPLC) areas. This text also presents an overview of Food and Drug Administration (FDA), and International Conference on Harmonization (ICH) regulatory guidelines.

---

Describes analytical methods development, optimization and validation, and provides examples of successful methods development and validation in high-performance liquid chromatography (HPLC) areas. The text presents an overview of Food and Drug Administration (FDA)/International Conference on Harmonization (ICH) regulatory guidelines, compliance with validation requirements for regulatory agencies, and methods validation criteria stipulated by the US Pharmacopia, FDA and ICH.

Autor

Michael E. Swartz, Ira S. Krull

Inhalt

Method development, optimization and validation approaches; method validation (USP/ICH); system suitability; method validation protocol; method transfer and revalidation.

Produkt-Details

• Erscheinungsdatum: 07.10.2017
• Verlagsort: London
• Sprache: englisch
• Maße: 138 x 216 mm
• Gewicht: 226 g
• Themenwelt: Naturwissenschaften ► Biologie
• Themenwelt: Naturwissenschaften ► Chemie ► Analytische Chemie
• ISBN-10: 1-138-40256-7 / 1138402567
• ISBN-13: 978-1-138-40256-0 / 9781138402560
• Zustand: Neuware