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At Aurigene, we help our clients understand the stability and quality of drug substances (API) and drug products (finished formulation) against different environmental factors such as temperature, humidity, and light. Our stability testing services are offered in accordance with IHC guidelines. They include the study of product-related factors that influence the quality of a drug, such as the interaction of an API with excipients, container closure systems, and packaging materials but also the proneness to oxidation and hydrolysis.

All stability samples are stored under controlled conditions such as incubators and stability chambers for accelerated/long-term/intermediate stability studies. The suitability of a drug substance or a drug product for its intended use is defined by attributes such as identity, strength, and purity.

Applying state-of-the-art equipment, our analytical team assesses the quality of drug substances and drug products as part of stability studies.

Thermal stability

In general, the drug substance and drug product are evaluated under storage conditions (with appropriate tolerances) that test its thermal stability and, if applicable, its sensitivity to moisture. The storage conditions and the lengths of studies are defined by regulatory guidelines such as ICH, but we also offer customized programs.

Possible conditions include:

Drug Substances
  • Long term: 25°C ± 2°C/60% RH ± 5% RH or 5°C ± 3°C
  • Accelerated: 40°C ± 2°C/75% RH ± 5% RH
Drug Product:
  • Long term: 25°C ± 2°C/60% RH ± 5% RH or 30°C ± 2°C/75% RH ± 5% RH
  • Intermediate: 30°C ± 2°C/65% RH ± 5% RH
  • Accelerated: 40°C ± 2°C/75% RH ± 5% RH

Photo stability

The intrinsic photostability characteristics of a new drug substance or drug product are assessed to demonstrate that light exposure does not result in unacceptable change. Usually, we conduct photostability testing for a single batch of the material selected as described under the selection of batches in the parent guideline. Under some circumstances, these studies can be repeated if certain variations and changes are made to the product (e.g., formulation, packaging). The repeat study helps us understand photostability characteristics determined at the time of initial filing and the type of variation and/or change made.

A systematic approach to photostability testing is recommended covering, as appropriate, studies such as:

  • Tests on the drug substance
  • Tests on the exposed drug product outside of the immediate pack; and if necessary
  • Tests on the drug product in the immediate pack; and if necessary
  • Tests on the drug product in the marketing pack.

In-use stability

Our in-use stability testing services help to establish the period during which a multi-dose product can be used while retaining quality within an accepted specification once the container is opened. The continued integrity of products in multi-dose containers after the first opening is an important quality issue.

Aurigene Pharmaceutical Services is

a leading CDMO/CRO

that provides contract research and manufacturing services

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