Author: pharmajia

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...

Neutral Code 0

Neutral Code

This article contains the information about the Neutral Code. Neutral Code A brief information About the Neutral Code : A “neutral code” is a unique alphanumeric identifier issued by a regulatory body , like...

Data Integrity Policy 0

Data Integrity Policy

This document provides the information on data integrity policy i.e. policy to investigate and handle incidences related to GXP data, identified during internal/external audit or during review of data at any stage. Data integrity...