Stability studies
For more than 30 years, we have been providing stability testing services of pharmaceuticals (investigational, development and commercial drug substances and drug products) to our clients.
We present reliable data by utilizing our extensive expertise and knowledge on various analytical studies as well as many inspection experiences from regulatory agencies worldwide.
Facility
- Oita Laboratory
- Osaka Laboratory
Operation system
- We conduct the stability studies based on ICH guidelines1).
- We conform to the Japan's Reliability Criteria2), and GMP (Japan, USA, and Europe).
Inspection and audit experiences
- FDA inspections, PMDA inspections, QP audits, audits by our domestic and foreign clients, etc.
Our Experience
Type of study
- Long-term testing, accelerated testing, stress testing, intermediate testing, etc.
- Stability studies for clinical trials (for IND, CTA), stability studies for registration applications (for NDA, MAA), etc.
IND：Investigational New Drug Application
CTA：Clinical Trial Application
NDA：New Drug Application
MAA：Marketing Authorization Application
- Thermal cycling stability studies to support transport and distribution (can be performed at temperature and duration requested by our client).
Type of Samples
- Small molecules, medium-sized molecules (nucleic acids, peptides), biologics (antibodies, next generation antibodies, mRNA, vaccines, proteins, etc.) and regenerative medicine, etc.
- Drug substances, intermediates, drug products *1, etc.
- *1: Tablets, capsules, granules, powders, injections, infusions, ointments/creams, suppositories, patches, etc.
- High potent substances (OEL>0.1μg/m3), narcotics and stimulants can be tested.
Support system
- Sample storage only is accepted.
- FTE(Full-Time Equivalent) program is applicable.
- It is possible to perform stability studies, together with analytical method development and method validation.
- Structural characterization of impurities based on ICH-Q3A3) and ICH-Q3B3).
- Stability monitoring testing and trend analyses of commercial drug products.
- Release testing after approval of pharmaceuticals.
- Dissolution testing for bioequivalence studies of generic drugs4).
- Preparation of dossier and reports in English for global drug application (USA, Europe, ASEAN countries, etc.)
- Support for preparation for pharmaceutical regulatory submission (preparation of CTD, etc.)
- Support for the compliance document review after filing a new drug application in Japan and other counties.
Test items
| Test Items | Methods |
|---|---|
| Description | Appearance |
| Identification test | IR, UV, TLC, etc. |
| Assay/Purity | HPLC, UHPLC, etc. |
| Residual solvent | GC, headspace GC, IC, etc. |
| Drug product testing | Dissolution, disintegration, insoluble foreign matter, insoluble particulate matter, formulation uniformity, osmolarity, container integrity test, etc. |
| Microbiological testing | Sterility test, microbial limit test, bacterial endotoxins test, etc. |
Sample storage facility
- We use NASTER system (manufactured by NAGANO SCIENCE) as a 24-hour monitoring system for sample storage facilities. (Temperature and humidity records are being backed up.)
- The temperature and humidity distribution in the chambers are checked at the time of installment and periodically.
- There is a back-up power source for disaster preparedness.
| Storage conditions | |
|---|---|
| Temperature | -80°C, -20°C, 5°C*3, 10°C*3, 40°C , 50°C , 60°C, etc. |
| Constant temperature and humidity | 25℃/60%RH*3、30℃/65％RH*3、30℃/75％RH*3、40℃/75%RH*3、30℃/35％RH, etc.(20-60°C, 30-90%RH can be used individually.) |
| Light | "Corresponds to ICH Q1B light sources. (D65, white fluorescence, near-ultraviolet fluorescence) Temperature and humidity control is possible." |
- *3: We have a large-volume storage facility (walk-in type).
Reference
- 2) Article 43 of Regulation for Enforcement of the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices
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