PerkinElmer

Stability Testing

Typically, both drug substance and drug product are tested in at least two different storage conditions: long term ambient storage temperature and accelerated conditions predicting product stability at a long period of time.

The purpose of stability testing is to understand how the quality of an Active Pharmaceutical Ingredient (API) varies when different environmental factors such as temperature, humidity and light are introduced. Stability testing also includes the study of product related factors that influence the quality of a drug, for example, interaction of API with excipients, container closure systems and packaging materials.

All drug products must be stored in appropriate, controlled conditions, while incubators and storage cabinets used for accelerated stability studies must be monitored. Storage space temperature mapping has become a key component of validation. Our OneSource® Services provide GLP/GMP compliant thermal mapping studies, including open door re-stabilization testing using test equipment calibrated to international standards.

The suitability of either a drug substance or drug product for its intended use is defined by attributes such as the identity, strength, and purity – which can be achieved by using instruments, consumables and services you can find from PerkinElmer.

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Analytical Chemistry Software

Solve problems in almost all areas of chemistry for all kinds of industries with PerkinElmer Informatics solutions. Quickly capture, structure and process analy ...

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Consumables

Partner with us and give your laboratory the benefits of cutting-edge instrumentation, consistently excellent consumables and the industry’s largest, most trust ...

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QA/QC Software

Organize all of the testing and results needed to control manufacturing processes and ensure the quality of raw materials, in process samples, and finished good ...

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UV/Vis Reference Materials

Accelerate the calibration verification of your materials characterization instruments. Our reference materials provide you with the evidence you need to pass t ...

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Degradation Products

Drug manufacturers may be required to accelerate or force degradation of a product to demonstrate that it has gone through the stability indicating method. In s ...

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Chromatography Instruments

Whatever your application, industry requirements or regulations, we have a breadth of solutions designed to solve your separation and detection challenges. Our ...

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Atomic Spectroscopy Instruments

If you're looking for world-leading AA, ICP-OES, ICP-MS, or mercury analysis systems, you've come to the right place. Tens of thousands of installations worldwi ...

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Molecular Spectroscopy Instruments

Characterize advanced complex materials on any budget. Our comprehensive portfolio of analytical solutions has the ideal molecular spectroscopy instruments for ...

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Thermal Analysis Instruments

Improve accuracy, sensitivity, and performance in thermal analysis using our comprehensive portfolio of instruments. Applications of our industry-leading techno ...

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Organic Elemental Analysis Instruments

For reliable elemental analysis and proven performance when analyzing carbon, hydrogen, nitrogen, sulfur, and oxygen (CHNS/O), we have the right solution for yo ...

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