Pharma Stability: Insights, Guidelines, and Expertise
SOP for Analyzing Stability Samples Using HPLC Procedure for Analyzing Stability Samples with High-Performance Liquid Chromatography (HPLC) 1) Purpose The purpose of this SOP is to provide a detailed procedure for analyzing stability samples using High-Performance Liquid Chromatography (HPLC) to determine the quality and stability of drug products over time. 2) Scope This SOP applies…
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How to Address Stability Testing for Drug Products with Multiple Active Ingredients under Regulatory Guidelines Stability Testing for Drug Products with Multiple Active Ingredients: A Regulatory Guide Introduction Drug products with multiple active ingredients, such as combination therapies, require thorough stability testing to ensure that each ingredient remains stable and maintains its intended efficacy and…
How to Implement ICH Q1A(R2) for Stability Testing in Tropical and Subtropical Regions Stability Testing in Tropical and Subtropical Regions: Applying ICH Q1A(R2) Guidelines Introduction Drug products intended for distribution in tropical and subtropical regions face unique challenges due to high temperatures and humidity levels that can affect their stability. The ICH Q1A(R2) guideline provides…
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How to Conduct Stability Studies for Drugs with Complex API in Compliance with Regulatory Guidelines Stability Testing for Drugs with Complex APIs: A Regulatory Compliance Guide Introduction Drugs with complex Active Pharmaceutical Ingredients (APIs), such as peptides, proteins, and other large molecules, pose unique challenges in stability testing due to their susceptibility to degradation and…
SOP for Performing Humidity Chamber Studies for Drug Products Procedure for Conducting Humidity Chamber Studies on Drug Products 1) Purpose The purpose of this SOP is to provide a standardized procedure for performing humidity chamber studies to evaluate the stability of drug products under various humidity conditions. 2) Scope This SOP applies to all drug…
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How to Apply ICH Q10 for Pharmaceutical Quality System in Stability Studies Applying ICH Q10 for Stability Studies: Enhancing Pharmaceutical Quality Systems Introduction ICH Q10, the Pharmaceutical Quality System guideline, provides a comprehensive framework for maintaining and improving the quality of pharmaceutical products throughout their lifecycle. Applying ICH Q10 principles to stability studies helps ensure…
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How to Conduct Stability Testing for Modified-Release Formulations in Compliance with Regulatory Guidelines Stability Testing for Modified-Release Formulations: Ensuring Regulatory Compliance Introduction Modified-release formulations, such as extended-release, delayed-release, and controlled-release products, are designed to release their active ingredients over a specific period. Stability testing for these formulations is critical to ensure they maintain their intended…
How to Implement ICH Q8 for Stability Testing in Pharmaceutical Development Applying ICH Q8 for Stability Testing in Pharmaceutical Development Introduction The ICH Q8 guideline, “Pharmaceutical Development,” emphasizes a systematic approach to development that ensures product quality through design, understanding, and control of manufacturing processes. Implementing ICH Q8 principles in stability testing helps to optimize…
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SOP for Conducting Photostability Testing of Drug Products Procedure for Photostability Testing of Drug Products 1) Purpose The purpose of this SOP is to provide a detailed procedure for conducting photostability testing of drug products to evaluate their stability when exposed to light, in order to determine suitable packaging and storage conditions. 2) Scope This…
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How to Prepare Stability Data for Compliance with FDA’s Quality by Design (QbD) Approach Stability Data Preparation for Compliance with FDA’s QbD Approach Introduction The FDA’s Quality by Design (QbD) approach emphasizes building quality into pharmaceutical products through a systematic understanding of processes and product characteristics. Preparing stability data under the QbD framework involves integrating…