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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Consumables & Accessories

Your partnership with PerkinElmer doesn't stop when you purchase an instrument. We also have a complete line of consumables and accessories engineered to keep 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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Explore Our Instruments

Chromatography

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

If you're looking for proven AA, ICP-OES, ICP-MS, or mercury analysis systems, you've come to the right place. PerkinElmer has been at the forefront of atomic s ...

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Molecular Spectroscopy

Today’s advanced and increasingly diverse Advanced Materials laboratories are facing new challenges daily – starting from raw materials right up to the finished ...

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Thermal Analysis

Improve accuracy, sensitivity, and performance using our comprehensive portfolio of instruments in Differential Scanning Calorimetry (DSC), Thermogravimetric An ...

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