Category: Quality control

Developed over 140 years ago by Danish chemist Johan Kjeldahl, the Kjeldahl method remains a globally recognized analytical technique for determining nitrogen content in various materials, including pharmaceutical products. In pharmacy, **what is Kjeldahl method in pharmacy?** is a key question that relates to quantifying nitrogen, which serves as a proxy for protein content or is a component of active pharmaceutical ingredients (APIs) and excipients. This comprehensive guide explores the principle, procedure, and specific applications of this robust analytical process within the pharmaceutical industry.

According to the EU GMP Guide Part I, a CoA provides an overview of test results for a product batch. **What is CoA in pharma?** It's a formal document issued during drug manufacturing and development to confirm that a specific batch of a product meets its pre-established quality specifications.

The pharmaceutical industry's reliance on computerized systems has grown exponentially, making a robust Computer System Validation (CSV) process more critical than ever before to ensure product quality and patient safety. This documented process proves that all software and hardware perform as intended throughout their entire lifecycle.

Saving time and resources during stability testing is a major objective for pharmaceutical companies. In this context, understanding what is bracketing in pharmacology is crucial for optimizing stability and validation studies by testing only the extremes of a product range.