We develop and validate stability indicating test methods for new drugs. With sustainable partnerships in mind, we promote analytical continuity in testing impurity profiles of new drug substances and corresponding new drug products. This is a key component of successful CMC section of regulatory submissions.
All analytical testing activities performed at KABS are executed in cGMP compliant facilities audited by Health Canada, USFDA, European QPs. A Continuous training program in cGMP guidelines and testing procedures is the cornerstone of our compliance.
Originally developed as a local reference testing laboratory, KABS steadily improved its facilities, instrumentation and quality systems in response to demands for advanced and integrated analytical support, worldwide. KABS is a WHO (World Health Organization) prequalified Quality Control Laboratory.
From pH to UPLC-MS/MS
Development and validation of stability indicating analytical methods.
Raw Materials
Drug substances, Excipients and Additives: Assay, Impurities/Degradation products and Organic Volatile Impurities.
Manufacturing Processes
Cleaning validation: Traces of active ingredients, residual detergents.
In-process testing: dissolution, content uniformity, hardness, thickness, viscosity, etc.
Drug Products
Tablets, capsules, syrups, gels, creams, aerosols, parenterals: Assay, impurities, OVI, dissolution, long-term and accelerated stability studies.
Chromatographic Instruments Selection
- HPLC detectors: UV, PDA, IC, EC, FR, ELSD, MS-MS
- UPLC detectors: UV, PDA, MS-MS
- GC detectors: FID, ECD, MS
- CE detectors: UV, PDA, MS
- Chiral chromatography (GC, HPLC and CE)
Transfer of methods and techniques to your lab
- Training: Courses on instruments, method development, validation, regulations
- Troubleshooting in your laboratory
- Interlaboratory validation
Stability studies
All stability studies are performed in fully qualified and validated walk-in incubators and/or freezers kept under the following conditions.
-80 ± 3°C
-20 ± 3°C
5 ± 2°C
25 ± 2°C / 60 ± 5% RH
25 ± 2°C / 75 ± 5% RH
30 ± 2°C / 60 ± 5% RH
30 ± 2°C / 65 ± 5% RH
40 ± 2°C / 75 ± 5% RH
Quality control analyses
- USP, BP, EP, JP, FCC methods
- In-house validated methods
- Containers permeability testing
- Gases (i.e., residual oxygen in sealed ampoules, containers)
- Diffusion testing from transdermal gels using Franz cells
General consulting services
- Solution for physico-chemical problems in your experimental formulations
- Isolation and identification of unknown impurities
- Scientific advice for your communications with regulatory agencies
- Solution for process inconsistencies and process validation
- Development, validation, troubleshooting of GC, LC-MS and CE methods
- Courses and training in all aspects of regulated analytical chemistry
Services for developers and manufacturers of biologics
- Determination of molecular weight (Ferguson plot method)
- Determination of isoelectric point
- Quantitative profiling by SDS-capillary gel electrophoresis
- Quantitative profiling by capillary isoelectric focussing
- Quantitative profiling of glycoforms by capillary electrophoresis or LC-MS/MS
- Quantitative profiling of oligosaccharides and saccharides (microheterogeneity)
- Quantitative profiling of monoclonal antibodies
- Biotechnological process validation
Natural Products Analysis
KABS offers expertise in fingerprinting, assay, analysis of heavy metals and analysis of organic volatile impurities for herbal products, either for qualification of raw materials or testing of finished products containing single or multiple herbal components.