From pH to UPLC-MS-MS
Originally developed as a reference testing laboratory, KABS steadily improved its facilities, instrumentation and quality systems in response to market demands for advanced analytical R&D approaches that are pre-requisites for the successful development of complex drug products.
Development and validation of stability indicating analytical methods
Raw Materials
Manufacturing Processes
In-process testing: dissolution, content uniformity, hardness, thickness, viscosity, etc.
Finished Products
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
- Quantitative profiling of oligosaccharides and saccharides (microheterogeneity)
- Quantitative profiling of monoclonal antibodies
- Biotechnological process validation
Natural product 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.
Species (measured chemotaxonomic marquers)
- Billberry (anthocyanosides)
- Cayenne (Capsaicinoids)
- Milk-Thistle (Sylimarin)
- Dong Quai (Ligustilides)
- Echinacea (Phenolics)
- Ginger (Gingerols)
- Aloe (Aloins)
- Garlic (Alliin, Allicin)
- Cascara Sagrada (Cascarosides, hydroxyanthracenes)
- Ginkgo Biloba (Flavonol glycosides)
- Cat's Claw (Oxyindoles)
- Devil's Claw (Harpagosides)
- Wild Yam Root (Diogenine)
- Saw palmetto (Free fatty acids)
- Feverfew (Parthenolides)
- Licorice Roots (Glycyrrhizine)
- Valerian (Valeric acid)
- Glucosamine Sulphate, Hydrochloride
- Goldenseal (Hydrastin)
- St-John's Wort (Hypericins)
- Ginseng Panax, Siberian, American (Ginsennosides)
- Sene (Sennosides)
