Based upon extensive experience accumulated over many years we can manage a broad range of conditions, formulations, regulatory requirements and other requirements related to stability tests.
Features
SCAS has a long history of meeting demands for stability tests related to a diverse range of pharmaceutical ingredients and drug products. Stability tests are efficiently conducted in accordance with various guidelines (Japanese regulation for approval application, cGMP), with reliable data supplied in a format appropriate for application purposes.
- Long-term storage tests, accelerated tests, stress tests, intermediate tests, etc.
- Specification analysis
- Sample storage
- Paper-based compliance inspection support
Testing system
- Japanese regulation for approval application
- Compliance with cGMP
Facilities
- Sample storage (5℃)
- Accelerated test (40℃－75%RH)
- Long-term storage test (25℃－60%RH, 30℃－75%RH)
- Light irradiation test equipment (D65 lamp)
- Intermediate test (30℃－65%RH）
Our Experience
- Number of contracted companies More than 40
- Test items Over 300 items
- Formulation Tablets, capsules, granules, fine grains, powdered medicine, injections, additives, liquid medicines, ointments, suppositories, aerosols, adhesives, drug ingredients
- Inspection by regulatory authorities Presence with Ministry of Health, Labour and Welfare onsite paper-based compliance inspection (numerous cases)
Technical News
Contact Us for Services
For inquiries and requests concerning services of analysis, measurements, products and consulting, please contact us via inquiry form.