Analytical Method Development and Validation

Buch | Softcover

96 Seiten

1997
Crc Press Inc (Verlag)
978-0-8247-0115-4 (ISBN)

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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.

Michael E. Swartz, Ira S. Krull

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

Erscheint lt. Verlag	16.5.1997
Verlagsort	Bosa Roca
Sprache	englisch
Maße	138 x 216 mm
Gewicht	180 g
Themenwelt	Naturwissenschaften ► Chemie ► Analytische Chemie
ISBN-10	0-8247-0115-1 / 0824701151
ISBN-13	978-0-8247-0115-4 / 9780824701154
Zustand	Neuware