Storage Stability Testing Services
Online InquiryThrough our global network of testing experts and analytical equipment including chromatography (HPLC, GC, GC/MS) and atomic absorption spectroscopy (AAS, GFA, FIAS), Our goal is to provide test services as efficiently as possible to maximize our customers' profits. For more information about our services, contact one of our experts today.
Note: this service is for Research Use Only and Not intended for clinical use.
In the drug development process, many testings are needed to ensure quality. The stability of the drug in storage is important to maintain its efficacy. The exaggerated environmental conditions are used to assess the impact of storage and transport on drug performance, identify potential chemical and physical changes, and provide information on the stability of clinical use.
Figure 1 Change in the physical appearance and surface condition of Aspirin Tablet before and after storage at 60°C for 4 Weeks1
Alfa Chemistry offers you with advanced pharmaceutical storage stability testing services. We can test your product's various performance changes under various humidity and temperature conditions according to your needs. We can recommend the most suitable transportation and storage conditions through the testings to ensure the drug does not lose the therapeutic properties and verify the shelf life of the product. Our storage conditions follow the guidance of ICH and ISO. All test solutions are customized by experienced teams familiar with the pharmaceutical industry. Alfa Chemistry is your ideal partner to provide you with low risk and high quality stability studies.
Alfa Chemistry provides stability experiments under different storage conditions:
| Intended Storage Condition | Stability Test Method | ICH Test Temperature, Humidity and Period | WHO Test Temperature, Humidity and Period |
|---|---|---|---|
| Room temperature | Long term | 25±2°C, 60±5% RH, 12 months | 25±2°C, 60±5% RH or 30±2°C, 65±5% RH or 30±2°C, 75±5% RH,12months |
| Intermediate | 30±2°C, 65±5% RH, 6 months | 30±2°C, 65±5% RH, 6months | |
| Accelerated | 40±2°C, 70±5% RH, 6 months | 40±2°C, 75±5% RH, 6months | |
| Refrigerated | Long term | 5°C, Ambient, 12 months | 5±3°C |
| Accelerated | 25±2°C, 60±5% RH, 6 months | 25 ±2°C, 60±5% RH or 30 ±2°C, 65±5% RH | |
| Freezer | Long term | -20°C, Ambient, 12 months | 20°C±5°C |
Alfa Chemistry has a wide range of equipments, such as:
UV Spectrometer
Infrared Spectrometer
NMR Spectrometer
High Performance Liquid Chromatography
Liquid Chromatography Mass Spectrometer
Gel Permeation Chromatography
Gas Chromatography
Gas Chromatography Mass Spectrometer
Fluorescence Spectrometer
Diffraction Spectrometer
Thermogravimetric Analysis
Differential Scanning Calorimeter
Alfa Chemistry's Advantages:
Short Detection Cycle
Competitive Price
Experienced Team of Experts
First-class Equipment
Reliable Results
Familiarity with Various Standards
References
Abe T1, Yanagihara Y, Uchino T, Oriyama T, Komatsu M, Nakajima K, Suzuki H. (2014) ‘Evaluation of the pharmaceutical characteristics of various enteric-coated aspirin tablets under different storage conditions.' Chem Pharm Bull, 62(7), 617-26.
Bajaj, S. (2012) ‘Stability testing of pharmaceutical products.' Journal of Applied Pharmaceutical Science, 2(3), 129-138.
ICH Q1A(R2). (2003) Stability testing guidelines: Stability testing of new drug substances and products.
WHO. (2004) Stability studies in a global environment. Geneva meeting working document QAS/05.146 with comments.
Do not know how to place an order, please refer to the flow chart shown below.
Submit quotation request |
A technical manager will contact you within 24 hours |
You will review and approve the final price and place an order |
Confirm with you and make the payment |
Instruct you to ship your samples and form |
Analytic report delivery |
