Category: Quality Control

Freeze Thaw Study in Pharmaceuticals

Freeze Thaw Study in Pharmaceuticals

Freeze Thaw Study in Pharmaceuticals: A Critical Stability Testing Tool Introduction In pharmaceutical development and quality control, stability testing plays a critical role in ensuring that a drug product maintains its safety, efficacy, and...

Accelerated Stability Testing

Accelerated Stability Testing

Accelerated Stability Testing in Pharmaceuticals: Fast-Tracking Product Shelf Life Evaluation Keywords: accelerated stability testing, pharmaceutical stability studies, ICH guidelines, shelf life prediction, drug stability testing, pharmaceutical quality assurance Introduction In the pharmaceutical industry, ensuring...

10 Steps to ensure accurate HPLC Results 0

10 Steps to ensure accurate HPLC Results

This article contains about 10 Steps to ensure accurate HPLC Results   10 Steps to ensure accurate HPLC Results High-Performance Liquid Chromatography (HPLC) is a powerful analytical technique widely used in pharmaceuticals, environmental testing,...

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...

Peak Splitting in Chromatography 0

Peak Splitting in Chromatography

This Article contains the information about Peak Splitting which is commonly observed in the Chromatographic analysis.. Peak Splitting in Chromatography : Peak splitting in chromatography refers to the appearance of shoulders or twin peaks...