Stability Testing
ServicesTestingStability TestingStability testing is a critical part of the drug development process that aims to ensure that a pharmaceutical product maintains the characteristics it demonstrated at the point of manufacture throughout its specified shelf life, including warehousing, transportation, storage, and at the point of dispensing or administration. Infinity Laboratories is equipped with the stability chambers, analytical instrumentation, and expertise needed to assure compliance with all ICH and USP guidelines, as well as standards set forth in the European and Japanese Pharmacopeias.
Stability testing is a critical part of the drug development process that aims to ensure that a pharmaceutical product maintains the characteristics it demonstrated at the point of manufacture throughout its specified shelf life, including warehousing, transportation, storage, and at the point of dispensing or administration. Infinity Laboratories is equipped with the stability chambers, analytical instrumentation, and expertise needed to assure compliance with all ICH and USP guidelines, as well as standards set forth in the European and Japanese Pharmacopeias.
Demonstrating Stability
Storage conditions, forced degradation, freeze/thaw, and photostability studies must be performed to demonstrate stability in these five areas.
Storage conditions, forced degradation, freeze/thaw, and photostability studies must be performed to demonstrate stability in these five areas.
Stability Testing Guidance
The International Conference on Harmonization (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use, ICH Harmonized Tripartite Guideline, Stability Testing of New Drug Substances and Products – Q1A(R2) is the primary guidance for drug products and substances marketed in the United States, Europe, and Japan.
Stability Testing Services
Infinity Laboratories stores samples in our GMP-compliant stability chambers and conducts the required testing at specified intervals. In addition to conducting the needed tests, we can help you determine your product’s appropriate storage conditions and shelf life, including helping to determine these factors for highly sensitive drug products.
Storage Conditions
Storage Conditions
Standard: ICH Q1A(R2)
A drug substance must be evaluated under storage conditions to test its thermal stability and, if applicable, its sensitivity to moisture. The storage conditions and study lengths should be sufficient to cover the storage, shipment, and subsequent use. Generally, a long term storage study will be at least 12 months, and intermediate and accelerated studies, approximately six months.
Forced Degradation
Forced Degradation
Standard: ICH Guideline Q1B
Forced degradation studies allow pharmaceutical developers and manufacturers to understand the degradation pathways of drug substances and products. These experiments expose the material(s) to external stressors like heat, light, acid, base, and oxidation to assess the stability of the components or end product.
Freeze-Thaw / Thermal Stress Testing
Freeze-Thaw / Thermal Stress Testing
Standard: Referenced within ICH Q1F
Freeze-thaw studies inflict a series of extreme temperature changes on a drug product. The sample is then analyzed for impacts on its integrity and therapeutic effectiveness.
Photostability
Photostability
Standard: ICH Guideline Q1B
Photostability studies evaluate drug substances to ensure that exposure to light does not result in unacceptable product degradation or other unacceptable changes.