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Compatibility Study on Container Closure System

Compatibility study is a process that evaluates the fact that there is no serious interaction between packaging systems and drugs, which leads to changes in the effectiveness and stability of drugs, or a safety risk; the study should include the effects of packaging materials on drugs and drug The impact of packaging materials.

For drugs, the packaging system should be suitable for its intended clinical purpose with the following characteristics: protection, compatibility, safety and functionality. The packaging system provides protection to meet the intended purpose on safety and efficacy; Meanwhile, it should have good compatibility with the drugs, that means it cannot introduce extractable s that can cause safety risk s or the level can meet safety requirements.

Our Advantages

The team led by professional scientists has extensive experience in the compatibility study on container closure system, such as glass, metal, plastic, rubber, silicone, etc.

In the field of semi-permeable packaging materials research, we have developed a comprehensive and mature solution, which can improve the efficiency and success rate of customer project application

Established a powerful and continuously updated spectrum library that can share data with our customers

Complies with GMP regulations and FDA 21CFR Part 11 data requirements

CMA / CNAS(ISO/IEC17025) Accreditation, cGMP compliance laboratory

Provide stable storage and stability test services simultaneously. The combination of compatibility research and stability study can greatly reduce the cost.

The Relationship Between E/L & Drug

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Current Regulations and Guidelines for Compatibility Study

ChP, 四部9621,药包材通用要求指导原则

ChP, 四部9622,药用玻璃材料和容器指导原则

化学药品与弹性体密封件相容性研究技术指导原则(试行),2018

ICH M7, Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk

ICH Q3D, Guideline for Elemental Impurities

EMEA, Guideline on Plastic Immediate Packaging Materials(2005)

EP, Chapter 3, Materials and Containers

USP 

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