Cleaning verification assays for highly potent compounds by high performance liquid chromatography mass spectrometry: Strategy, validation, and long-term performance-Reference-Cited by-同舟云学术

Cleaning verification assays for highly potent compounds by high performance liquid chromatography mass spectrometry: Strategy, validation, and long-term performance

Published:2007-03 Issue:4 Volume:43 Page:1206-1212
ISSN:0731-7085
Container-title:Journal of Pharmaceutical and Biomedical Analysis
language:en
Short-container-title:Journal of Pharmaceutical and Biomedical Analysis

Author:

Liu Li,Pack Brian W.

Publisher

Elsevier BV

Subject

Clinical Biochemistry,Spectroscopy,Drug Discovery,Pharmaceutical Science,Analytical Chemistry

Reference13 articles.

1. Guide to Inspections of Validation of Cleaning Processes, Food and Drug Administration, Washington DC, USA, 1993.

2. Development and validation of a liquid chromatographic method for the determination of amlodipine residues on manufacturing equipment surfaces

3. Cleaning level acceptance criteria and a high pressure liquid chromatography procedure for the assay of Meclizine Hydrochloride residue in swabs collected from pharmaceutical manufacturing equipment surfaces

4. Development and validation of an LC assay for sumatriptan succinate residues on surfaces in the manufacture of pharmaceuticals

5. A validated HPLC method for determining residues of a dual active ingredient anti-malarial drug on manufacturing equipment surfaces

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