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 for quality control can also be transferred, validated or developed de novo. Our quality control laboratory works 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. Our quality control laboratory works with 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
Biosimilar testing
Laboratory analytist with test tubes
Extractables and Leachables GC-MS Agilent 7890

Kymos offers in addition to GMP quality control 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.

Batch Testing and Batch Release

Related Services to Quality Control of Small Molecules

Batch Testing and Batch Release

KYMOS and PHARMAPROGRESS are GMP certified and we have a partial manufacturer authorization for Quality Control purposes.

Method Development, Validation and Transfer

Development and validation of analytical methods for excipients, APIs, intermediate products and finished products.

ELEMENTAL, NITROSAMINES  OTHER IMPURITY TESTING

We offer GLP Cell-based neutralizing antibody assays for biologics and GMP Cell-based potency assays for vacines and other biologics.

Extractables and Leachables

Semi-quantitative screening for both volatile, semi-volatile and non-volatile organic compounds.

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