KYMOS Group

Parc Tecnològic del Vallès. Ronda Can Fatjó 5, Edificio D. 08290 Cerdanyola del Vallès, Barcelona

QUALITY CONTROL OF SMALL MOLECULES

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 can also be transferred, validated or developed de novo, and for Quality Control purposes we work under approved Quality Agreements and issue GMP Certificates of Analysis (CoAs) signed by our QPs. These 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