Regulatory Pharma Blogs
Q4B Annex 14 Bacterial Endotoxins Test: General Chapter 1. Introduction: Bacterial Endotoxins Test Bacterial Endotoxins Test: This annex is the outcome of the Q4B process, which pertains to the Bacterial Endotoxins Test General Chapter. The proposed texts were submitted by the Pharmacopoeial Discussion Group (PDG), which is a global body composed of the major pharmacopoeias …
Q4B ANNEX 13 Bulk Density and Tapped Density of Powders: A Comprehensive Overview 1. Introduction: Bulk Density and Tapped Density Bulk Density and Tapped Density: The Bulk Density and Tapped Density of powders are essential parameters in various industries, particularly in pharmaceuticals. They provide critical information about the flow properties, packing behavior, and compactibility of …
Q4B Annex 12 Analytical Sieving General Chapter 1. Introduction: Analytical Sieving Analytical Sieving: The document at hand represents the outcome of the Q4B process regarding the Analytical Sieving General Chapter. The proposed texts, which are the result of deliberations and discussions within the Pharmacopoeial Discussion Group (PDG), aim to harmonize the approach to analytical sieving …
Q4B Annex 11 Capillary Electrophoresis General Chapter 1. Introduction: Capillary Electrophoresis Capillary Electrophoresis : This annex results from the ICH (International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use) Q4B process, focusing on the General Chapter for Capillary Electrophoresis. The proposed guidelines and texts were submitted by the Pharmacopoeial Discussion Group (PDG). …
Q4b Annex 10(R1) Polyacrylamide Gel Electrophoresis General Chapter 1. INTRODUCTION: Polyacrylamide Gel Electrophoresis Polyacrylamide Gel Electrophoresis:This document is the outcome of the Q4B process for the Polyacrylamide Gel Electrophoresis (PAGE) General Chapter. The proposed texts contained within this annex were submitted by the Pharmacopoeial Discussion Group (PDG). The intention of this annex is to establish …
Q4B Annex 9(R1) Tablet Friability General Chapter 1. Introduction: Tablet Friability Tablet Friability: This document is part of the Q4B initiative, which is aimed at harmonizing pharmacopoeial standards internationally, specifically for the Tablet Friability General Chapter. This particular annex presents the outcome of the Q4B process concerning the assessment and evaluation of various pharmacopoeial texts …
Q4B Annex 8(R1) Sterility Test General Chapter 1. Introduction: Sterility Test Sterility Test : The following document is part of the Q4B process concerning the Sterility Test General Chapter. It outlines the outcome and implementation guidance for harmonized sterility testing procedures across different pharmacopoeial standards. The proposed texts and guidelines are submitted by the Pharmacopoeial …
Q4b Annex 7(R2) Dissolution Test General Chapter 1. INTRODUCTION: Dissolution Test Dissolution Test :This annex has been developed as part of the Q4B process concerning the Dissolution Test. The proposed texts within this document were submitted by the Pharmacopoeial Discussion Group (PDG), which is responsible for the evaluation and harmonization of pharmacopoeial standards across different …
Q4B Annex 6 Uniformity of Dosage Units: General Chapter 1. Introduction: Uniformity of Dosage Units Dosage Units: This document represents the outcome of the Q4B evaluation process for the Uniformity of Dosage Units General Chapter. The annex describes the findings and recommendations resulting from the efforts to harmonize standards across various pharmacopoeias. It is a …
Q4B Annex 5 (R1) General Chapter on Disintegration Test 1. Introduction: Disintegration Test Disintegration Test: This annex is part of the Q4B process aimed at harmonizing the Disintegration Test General Chapter. The content of this document was compiled by the Pharmacopoeial Discussion Group (PDG). The goal is to standardize methods and provide consistency across the …