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Pharma Stability: Insights, Guidelines, and Expertise

Tag: Photostability testing

Trends in Sustainable Packaging for Enhanced Stability Monitoring

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Trends in Sustainable Packaging for Enhanced Stability Monitoring Exploring Trends in Sustainable Packaging for Stability Monitoring Introduction Sustainability has become a critical focus in the pharmaceutical industry as companies seek to balance environmental responsibility with stringent stability and regulatory requirements. Advanced sustainable packaging solutions are being developed to provide robust protection for pharmaceutical products while…

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Packaging - Containers - Closers

SOP for Assessing Stability for Drug Products in Extreme Conditions

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SOP for Assessing Stability for Drug Products in Extreme Conditions Guidelines for Stability Testing of Drug Products Under Extreme Conditions 1) Purpose The purpose of this SOP is to provide a standardized procedure for conducting stability studies on drug products under extreme conditions. Stability testing ensures that drug products maintain their safety, efficacy, and quality…

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Stability Studies SOP

The Role of Excipients in Packaging Compatibility for Biopharmaceuticals

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The Role of Excipients in Packaging Compatibility for Biopharmaceuticals Understanding the Role of Excipients in Packaging Compatibility for Biopharmaceuticals Introduction Excipients play a crucial role in the formulation of biopharmaceuticals, ensuring their stability, efficacy, and manufacturability. However, excipients can also interact with packaging materials, leading to potential stability issues or product degradation. As biopharmaceuticals are…

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Packaging - Containers - Closers

SOP for Conducting Stability Studies for Temperature-Sensitive Biologics

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SOP for Conducting Stability Studies for Temperature-Sensitive Biologics Guidelines for Stability Testing of Temperature-Sensitive Biologics 1) Purpose The purpose of this SOP is to provide a standardized procedure for conducting stability studies on temperature-sensitive biologics. Stability testing is necessary to ensure that these biologics maintain their safety, efficacy, and quality under various storage conditions throughout…

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Stability Studies SOP

Innovations in Blister Packaging for Long-Term Stability Studies

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Innovations in Blister Packaging for Long-Term Stability Studies Innovative Approaches in Blister Packaging for Long-Term Stability Studies Introduction Blister packaging has long been a popular choice in the pharmaceutical industry for its ability to protect individual doses of drugs from environmental factors such as moisture, oxygen, and light. Recent advancements in blister packaging have enhanced…

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Packaging - Containers - Closers

How to Design Real-Time Stability Studies for Advanced Packaging Systems

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How to Design Real-Time Stability Studies for Advanced Packaging Systems Designing Real-Time Stability Studies for Advanced Pharmaceutical Packaging Introduction Real-time stability studies are essential for evaluating the performance of advanced packaging systems in maintaining the quality, efficacy, and safety of pharmaceutical products. These studies simulate actual storage conditions over the product’s intended shelf life, providing…

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Packaging - Containers - Closers

SOP for Performing Stability Studies for Sterile Products

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SOP for Performing Stability Studies for Sterile Products Guidelines for Stability Testing of Sterile Products 1) Purpose The purpose of this SOP is to provide a standardized procedure for conducting stability studies on sterile products. Stability testing is essential to ensure that sterile products maintain their sterility, safety, efficacy, and quality under various storage conditions…

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Addressing Humidity Sensitivity in Packaging Materials for Pharmaceuticals

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Addressing Humidity Sensitivity in Packaging Materials for Pharmaceuticals How to Address Humidity Sensitivity in Pharmaceutical Packaging Materials Introduction Humidity is one of the most critical environmental factors that can adversely affect the stability of pharmaceutical products. Many drugs, especially solid dosage forms, are hygroscopic and susceptible to degradation when exposed to moisture. Packaging materials play…

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Packaging - Containers - Closers

Shelf Life Determination for Solid Dosage Forms in Advanced Packaging

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Shelf Life Determination for Solid Dosage Forms in Advanced Packaging Determining Shelf Life for Solid Dosage Forms in Advanced Packaging Introduction Shelf life is a critical parameter in pharmaceutical development, ensuring that solid dosage forms like tablets and capsules maintain their efficacy, safety, and quality over time. Advanced packaging solutions play a pivotal role in…

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Packaging - Containers - Closers

SOP for Assessing Stability for Enzyme-Based Drugs

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SOP for Assessing Stability for Enzyme-Based Drugs Guidelines for Stability Testing of Enzyme-Based Drugs 1) Purpose The purpose of this SOP is to provide a standardized procedure for conducting stability studies on enzyme-based drugs. Stability testing is essential to ensure that enzyme-based drugs maintain their activity, safety, efficacy, and quality throughout their shelf life under…

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  • Include Microbial Limits Testing in Stability Studies Where Applicable

    Understanding the Tip: What is microbial limits testing in stability studies: Microbial limits testing evaluates the total microbial count and the presence of specific objectionable… Read more

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