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{ "item_title" : "HPLC Assay Method Validation Guide", "item_author" : [" Mirela Gorjanu "], "item_description" : "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)", "item_img_path" : "https://covers1.booksamillion.com/covers/bam/9/79/819/624/9798196240096_b.jpg", "price_data" : { "retail_price" : "24.99", "online_price" : "24.99", "our_price" : "24.99", "club_price" : "24.99", "savings_pct" : "0", "savings_amt" : "0.00", "club_savings_pct" : "0", "club_savings_amt" : "0.00", "discount_pct" : "10", "store_price" : "" } }
HPLC Assay Method Validation Guide|Mirela Gorjanu

HPLC Assay Method Validation Guide : Practical Pharmaceutical Method Validation, Troubleshooting, Data Integrity, GMP Compliance & Regulatory Insights

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Overview

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(TM) series - applied knowledge for pharma professionals.

- Mirela Gorjanu, Practical Pharma Science(TM)

This item is Non-Returnable

Details

  • ISBN-13: 9798196240096
  • ISBN-10: 9798196240096
  • Publisher: Independently Published
  • Publish Date: May 2026
  • Dimensions: 11 x 8.5 x 0.35 inches
  • Shipping Weight: 0.86 pounds
  • Page Count: 162

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