We aim at providing pharmaceutical stability solutions that include the study of product-related factors that influence the quality of a drug, such as the:
Interaction of an API with excipients Identification and prevention of degradation pathways in product Container closure systems
All stability samples are stored under controlled conditions such as incubators and stability chambers for accelerated or long-term or 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.
Thermal Stability
In general, the drug substance and drug product are evaluated under storage conditions (with appropriate tolerances) that test their thermal stability and if applicable, their sensitivity to moisture. The storage conditions and the lengths of studies are defined by regulatory guidelines.
Conditions
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
Photostability
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 (such as formulation and 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, based on studies such as:
- Tests on the drug substance
- Tests on the exposed drug product outside of the immediate pack
- Tests on the drug product in the immediate pack
- 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.
Why Aurigene Pharmaceutical Services?
State-of-the-art infrastructure
Capability to perform various forms of stability testing
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Bangalore R and D Center
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JUNE 28, 2022
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Building successful long-term partnerships with CDMOs from early drug discovery through commercialization
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Technology meets sustainability - How a complex API development process goes green
We are always looking for ways to enhance the sustainability of our products and services. Our team successfully developed a scalable manufacturing process for the API product of one of our Biotech clients using eco-friendly manufacturing technologies. Read the case study to learn more. ...
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Synthesis of Anti-covid Drug Nirmatrelvir Using Flow Chemistry
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