QUALITY CONTROL OF SMALL MOLECULES

Kymos provides GMP-certified quality control for small molecule analytes such as raw materials, APIs, excipients, intermediates, IMPs, finished products, packaging materials, manufacturing equipment and process environment samples according to customer specifications or relevant pharmacopoeia (EP, USP, BP, JP). Non-compendial methods for quality control can also be transferred, validated or developed de novo. For quality control purposes we work under approved quality agreements and issue GMP Certificates of Analysis (CoAs) signed by our QPs. These quality control assays target manufacturers of drug substances and products in need of outsourcing specific techniques, non-routine tests as well as routine batch testing and release. Quality control involves multiple disciplines:

General identification test (IR, TLC, HPLC)
Appearance (colour, clarity)
Assay (UV/Vis, AAS, titration, HPLC/UHPLC with multiple detectors, GC, GC/MS, LC/MS) and dosage uniformity
Related substances identification and quantification (GC, HPLC, GC/MS, LC/MS)
Physical determinations (pH, viscosity, density, polarimetry, refraction index, melting point, osmolality)
Moisture (Karl Fisher, loss on drying)
Limit tests (sulfated ash, wet-chemistry tests)
Residual solvents (volatile organic compounds, organic volatile impurities)
Impurities identification (HPLC/UHPLC, LC-MS, GC-MS)
Impurities determination: degradation products, process and drug related impurities
Elemental impurities (AAS, ICP/MS)
Nitrosamine impurities (LC-MS-MS, HS-GC-MS)
Solid oral dosage tests (disintegration, dissolution, hardness, friability)
Particulate matter (visible and subvisible particles)
Particle size distribution (Malvern Mastersizer 3000)
Process environment analysis (cross-contamination, rinse water from cleaning process, swabbing surfaces)
Analysis of Orally and Nasal Inhaled Drug Products (Andersen and New Generation Impactors)
Extractables & Leachables
In vitro release testing for semi-solids (vertical diffusion cells)
Total Organic Carbon (TOC)
Other CMC tests with specific departments

Extractables and Leachables GC-MS Agilent 7890

Batch testing and batch release OF SMALL MOLECULES

Kymos offers in addition to quality control GMP-certified importation, batch testing and batch release services. We have several QPs and are certified importers and manufacturers for quality control of human, veterinary and investigational medicinal products (IMPs), with capabilities to test and release sterile, non-sterile products and high potency active ingredients (HAPI). Find out more on our service page Batch testing and Batch release.