Pharma Specialists

Impurities

Residual Solvents in Formulation Development

Residual solvents are organic volatile chemicals used in the pro…

January 16, 2025

Impurities

Role of LD50 in Justification for Higher Limits of Impurities

LD50 (Lethal Dose 50) data, which measures the dose of a substan…

January 15, 2025

Impurities

Justification for Higher Limit of Impurities in Formulation

If you use higher specifications than Q3B guidelines for impurit…

January 14, 2025

Impurities

Explanation of Impurity Thresholds and Fixing Limits

The thresholds and procedures for setting impurity limits are de…

January 13, 2025

Impurities

Known and Unknown Impurities in Formulation Development

In pharmaceutical development, impurities are unwanted substance…

January 11, 2025

Impurities

Basic Concepts of Organic and Inorganic Impurities

1. Organic Impurities Nature: Compounds containing carbon and hy…

December 19, 2024

Impurities

Evaluation Options of Elemental Impurities

The product assessment will form the basis of a specific contr…

November 24, 2022

Impurities

Elemental Impurities Risk Assessment for Pharmaceutical Products

Nowadays, elemental impurities is a major concern for pharmaceut…

September 12, 2022

Impurities

Nitrosamine Risk Assessment for Human Drug Products

Nitrosamine impurities for human drug products considering the r…

September 10, 2022

Impurities

Difference between Related Substances and Impurities

Q. What is the difference between Related Substances and Impurit…

July 14, 2022

Contamination

How do you control multiple nitrosamine contaminants in a product?

The EMA/CMDh question and answer document on nitrosamine impurit…

February 23, 2022

ICH

Impurities: Guideline for Residual Solvents | ICH Q3C (R8)

Residual solvent in pharmaceuticals is defined as organic volati…

January 30, 2022

ICH

An Overview of Pharmaceutical Impurities

Pharmaceutical impurities are the unwanted chemicals that remain…

September 05, 2021