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Biowaiver Criteria 0

Biowaiver Criteria

  This article contains Biowaiver Criteria for Multiple Strengths Across Regulatory Bodies: Biowaiver Criteria for Multiple Strengths Biowaiver Criteria for Multiple Strengths Across Regulatory Bodies (When Bioequivalence study is Done on One Strength) When...

Stability Study Requirements 0

Stability Study Requirements

This article contains the Stability Study requirements Across Major Regulatory Agencies Stability Study Requirements Across Major Regulatory Agencies 1. USFDA for USA Guideline Reference : ICH Q1A(R2) Conditions: Long-term: 25°C ± 2°C / 60%...

Orthophosphoric acid (H₃PO₄) usages 0

Orthophosphoric acid (H₃PO₄) usages

Why Orthophosphoric acid (H₃PO₄) is commonly used for pH adjustment in High-Performance Liquid Chromatography (HPLC) analysis, in the pharmaceutical industry. Orthophosphoric acid (H₃PO₄) usages in Chromatography Orthophosphoric acid (H₃PO₄) is commonly used for pH...