August 2025 | Zaims Pharma

R&D Guide to Dissolution Specification Setting- Global regulatory

August 30, 2025 by samitfm

R&D Guide to Dissolution Specification Setting- Global regulatory Dissolution Specification Setting: Establishing dissolution specifications during the research and development (R&D) stage is one of the most critical activities in pharmaceutical product development. These specifications act as a bridge between laboratory findings and real-world drug performance, ensuring that the formulation consistently delivers therapeutic benefits while also …

The f₂ Similarity Factor in Dissolution Testing-2

August 30, 2025 by samitfm

The f₂ Similarity Factor in Dissolution Testing-Finished Products f₂ Similarity Factor: One of the most common questions that arises during discussions on dissolution testing is: What exactly is the f₂ factor, and how should it be applied in practice? The f₂ factor, often called the similarity factor, is a mathematical tool that evaluates how closely …

Dissolution f₂ in Multimedia a is True Indicator of Bioequivalence?

August 28, 2025 by samitfm

Dissolution f₂ in Multimedia a is True Indicator of Bioequivalence? Dissolution f₂ in pharmaceutical sciences, ensuring that a generic product behaves in the same way as its reference drug is central to regulatory approval and therapeutic confidence. One of the mathematical tools frequently applied for this purpose is the similarity factor, widely known as f₂. …

Q6A Specifications: Testing Procedures And Acceptance

August 8, 2025 by samitfm

Specifications: Testing Procedures And Acceptance Standards For New Drug Substances And Products: Chemical Substances: INTRODUCTION: Specifications 1.1 Purpose of the Guideline Specifications : This guideline is designed to support the development of a unified set of global specifications for new drug substances and products. It offers direction on establishing and justifying acceptance criteria and selecting …

Biotechnological/Biological Products Specifications Q6B

August 6, 2025 by samitfm

Biotechnological/Biological Products Specifications: Test Procedures And Acceptance Criteria 1. Objective and Background: Biotechnological/Biological Biotechnological/Biological: Objective: The document provides general principles for setting and justifying specifications for biotechnological and biological products, specifically proteins, polypeptides, and their derivatives, produced from recombinant or non-recombinant cell culture expression systems. Background: Specifications define the tests, procedures, and acceptance criteria needed …

Q4B Annex 14 Bacterial Endotoxins Test

August 4, 2025August 4, 2025 by samitfm

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 Bulk Density and Tapped Density of Powders

August 4, 2025August 2, 2025 by samitfm

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

August 4, 2025August 1, 2025 by samitfm

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 …