HPLC Assay Method Validation Guide (Paperback)
Language: English
Published by Independently Published, 2026
Series: Book 1 of 14 - Practical Pharma Science™ - Applied Knowledge for Pharma Professionals
- Softcover
- New
Seller: Grand Eagle Retail, Bensenville, IL, U.S.A.Grand Eagle Retail
AbeBooks seller since October 12, 2005
Condition: New
£ 24.35
Quantity: 1 available
Add to basketItem description from seller
Paperback. Your HPLC method passed development. Will it survive validation - and the audit after?The HPLC Assay Method Validation Guide is a visual, bench-ready reference for pharmaceutical analysts, QC laboratories and analytical scientists who need validation work to be right the first time. Written by a practising pharmaceutical analytical scientist, it turns regulatory requirements into clear, structured steps you can apply in the lab immediately.Inside you'll find: Method validation, parameter by parameter, aligned with ICH Q2 expectationsReal-world troubleshooting for the chromatographic problems that derail validation runsData integrity and GMP compliance - what auditors look for and how to stay inspection-readyChromatogram interpretation with colour-coded, infographic-style explanationsWorkflows and templates that bring structure to protocols and reportsRegulatory insights that connect the science to FDA and ICH requirementsWho it's for: QC and R&D analysts, method development and validation scientists, lab supervisors, QA reviewers, and graduates entering regulated pharmaceutical laboratories.Part of the Practical Pharma Science(TM) series - applied knowledge for pharma professionals.- Mirela Gorjanu, Practical Pharma Science(TM) This item is printed on demand. Shipping may be from multiple locations in the US or from the UK, depending on stock availability.…
Seller Inventory # 9798196240096
- Title
- HPLC Assay Method Validation Guide (Paperback)
- Author
- Mirela Gorjanu
- Publisher
- Independently Published
- Publication year
- 2026
- Condition
- new
- Binding
- Paperback
- Language
- English
- ISBN 13
- 9798196240096
- Series
- Book 1 of 14: Practical Pharma Science™ - Applied Knowledge for Pharma Professionals
Your HPLC method passed development. Will it survive validation — and the audit after?
The HPLC Assay Method Validation Guide is a visual, bench-ready reference for pharmaceutical analysts, QC laboratories and analytical scientists who need validation work to be right the first time. Written by a practising pharmaceutical analytical scientist, it turns regulatory requirements into clear, structured steps you can apply in the lab immediately.
Inside you'll find:
- Method validation, parameter by parameter, aligned with ICH Q2 expectations
- Real-world troubleshooting for the chromatographic problems that derail validation runs
- Data integrity and GMP compliance — what auditors look for and how to stay inspection-ready
- Chromatogram interpretation with colour-coded, infographic-style explanations
- Workflows and templates that bring structure to protocols and reports
- Regulatory insights that connect the science to FDA and ICH requirements
Who it's for: QC and R&D analysts, method development and validation scientists, lab supervisors, QA reviewers, and graduates entering regulated pharmaceutical laboratories.
Part of the Practical Pharma Science™ series — applied knowledge for pharma professionals.
— Mirela Gorjanu, Practical Pharma Science™
"Synopsis" may belong to another edition of this title.
Grand Eagle Retail
Bensenville, IL, U.S.A.
AbeBooks seller since October 12, 2005
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