Shelf-life testing is an essential part of the development and maintenance of drugs, OTCs, and APIs. Chromak Research has of 30 years of testing the shelf lives for APIs and Drug products. Chromak Research Testing Laboratory is equipped with full range stability chambers for storage of samples for Expiration Dating. Our data has been used to support numerous product registrations and NDA filings. Chromak Research stores samples and provides testing on these samples at the specified time intervals when test services are required by its Clients. Please contact us today for a quote.

Benefits of Chromak Services
  • Validated Stability Chambers per FDA and ICH Guidelines
  • Stability Tracking
  • New State-of-the-Art Storage Space
  • Retention Samples Maintenance and Secure Storage
  • Testing of Active Pharmaceutical Ingredients and Finished Products
  • DEA Registered for Controlled Drug Substances
Stability Storage Conditions
  • Refrigerated at 2° to 8°C.
  • 25° ± 2°C with Ambient Humidity
  • 25° ± 2°C with 60% ± 5% Relative Humidity
  • 30° ± 2°C with 65% ± 5% Relative Humidity
  • Accelerated at 40° ± 2°C Ambient Humidity
  • Accelerated at 40° ± 2°C with 75% ± 5% Relative Humidity
  • Accelerated at 45° ± 2°C with Ambient Humidity
  • Accelerated at 50° ± 2°C with Ambient Humidity
  • Other Conditions Available on Request

Stability testing is used to assess how the quality of a drug substance or drug product, and it’s packaging, varies with time under the influence of environmental factors such as temperature, humidity and light. Stability testing is an important part of various drug development and approval process as it determines the safety and integrity of the drug and also its shelf life and storage conditions. At our Chromak Research, we have the ability to conduct stability studies (Real time and accelerated) of various products from manufacturing, pharmaceutical and chemical companies by following ICH Q1 guidelines. The stability test determines whether any physical, chemical or microbiological changes affect the efficiency and integrity of the final product. The stability test ensures that a pharmaceutical product is safe and effective up to the mark. Stability testing establishes the shelf life and recommended storage conditions of a finished product. Our Testing Laboratory is equipped with full range stability chambers for storage of samples for Expiration Dating. Chromak Research stores samples and provides testing on these samples at the specified time intervals when test services are required by its clients.