Quality Control of Small Molecules

GMP-certified quality control services for small molecules according to customer specifications or relevant pharmacopeia.

Kymos Group 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.

Analytisches CRO HPLCs
Laboratory analytist with test tubes
GC-MS Agilent 7890

Services

Our capacities and technologies:

Kymos Group quality control of small molecule laboratory has experience with:

  • 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

Batch Testing and Batch Release of Small Molecules

Kymos Groups offers GMP quality control certified importation, batch testing and batch release services:

  • We have several Qualified Persons (QPs) and are certified importers and manufacturers for quality control of:
    • Human medicinal products
    • Veterinary medicinal products
    • Investigational medicinal products (IMPs)
  • Our capabilities include testing and releasing:
    • Sterile products
    • Non-sterile products
    • High-potency active ingredients (HAPI)
Batch Testing and Batch Release

Services

Related services to Quality Control of Small Molecules

extractables and leachables

Extractables and Leachables

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

Test tube in laboratory

Method Development, Validation and Transfer

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

Analytisches CRO HPLCs

Batch Testing and Batch Release

Our laboratories are GMP certified and we have a partial manufacturer authorization for Quality Control purposes.

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