Stability Studies
Stability Testing
Stability testing of pharmaceutical products and storage follow a complex set of procedures involving considerable time, cost and scientific expertise in order to build in quality, efficacy and safety in drug formulations. Stability testing or GMP stability testing is critical at every step during drug or product development to determine the shelf life and storage conditions in conformance with stipulated standards.
Stability testing or studies is some of the most important step during the drug development process because it is required to assure the identity, potency and purity of ingredients, as well as those of the formulated pharmaceutical products or Active Pharmaceutical Ingredients (API). Evaluation of these formulations or products against varying environmental conditions such light, temperature, moisture, etc. provide relevant, real-time insights about their applications and how they may differ due to changes in storage factors.
For a pharmaceutical or chemical company, choosing an experienced stability partner who possesses the right infrastructure – such as stability walk-in chambers, photostability chamber, etc. – and the analytical resources for stability testing can determine the product success or failure.
Storage
Precise Analytics Lab. is well equipped with stability walk-in chambers that can be set at different temperatures and humidity with validated monitoring systems. We also have a photo stability chamber to carry out photo stability testing. Our technologically-enhanced stability testing labs and experienced analysts and scientists provide GMP stability testing for pharmaceutical companies.
We carry out all ICH and Specific Conditions stability studies and the stability studies are carried out under the following range of stability conditions.
| Temperature | Humidity |
|---|---|
| 30°C ± 2°C | 65% ± 5% |
| 30°C ± 2°C | 75% ± 5% |
| 40°C ± 2°C | 75% ± 5% |
| 25°C ± 2°C | 60% ± 5% |
| 2°C - 8°C | No Humidity |
The features offered by our stability testing labs include:
- Long-term, real-time stability studies/testing
- Short-term accelerated stability studies
- Photo stability and forced degradation studies
Testing
Our stability testing processes serve to enhance product and drug development by critical identification of stability that is essential for product validation. Stability testing involves determining degradation factors and time taken for degradation. Routine assays for various parameters such as temperature, moisture content, residue presence, microbial presence, etc. are also conducted.
During the period of stability testing, we periodically test for identification, physical appearance, disintegration, dissolution, loss on drying, related substances, assay, residual solvents, microbial testing etc., to determine the accurate stability of product. Our experienced team and high-technology infrastructure complement each other to provide stability studies that are precise in real-time conditions thought the product lifecycle.
Forced degradation studies during stability testing include the following parameters:
- Acid and Alkaline Hydrolysis
- Oxidation
- Thermal
- Humidity
- Fotolic
- Fluorescent light
- Metallic Ions (Cu II or Fe III)
Contact us for your stability testing or photo stability testing needs.
FAQ's
25°C/60% RH, 30°C/65% RH, 30°C/75% RH and 40°C/75% RH (±2°C, ±5% RH), plus refrigerated storage at 2–8°C, in validated walk-in chambers.
Long-term real-time studies, short-term accelerated studies, photostability studies and forced degradation studies — all ICH and specific-condition studies.
We test to IP, BP, EP and USP, to IS specifications for water, and to ICH guidelines for elemental impurities, stability and method validation.
We are a BIS approved, Government and FDA approved laboratory, holding FDA Maharashtra licences 37-KD-TL/016 and 48-MH/103172. Our quality system follows the requirements of IS/ISO/IEC 17025.
Send an enquiry first. Once feasibility is confirmed and you have our quotation, deliver samples to our laboratory in Wagle Estate, Thane, or ask us to arrange collection.
It depends on the tests, methods and sample type — stability studies, for example, run over defined storage periods. We confirm the expected timeline with your quotation.
Yes. Each sample receives a Certificate of Analysis, released only after the report and raw data are verified by the Section Head and QA.
Share your sample details and requirements through our enquiry form. We send quotations by email.
Need accurate, compliant testing for your products?
Share your sample details and requirements. We’ll confirm feasibility, recommend the right analytical approach and send you a quotation.