Kymos Group provides GMP-certified analysis for all raw materials used in the pharmaceutical industry. Both APIs (active pharmaceutical ingredients) and excipients must be tested to show they are fit to be used in pharmaceutical preparation.
Therefore, the compliance of all the parts involved in the product consumed is mandatory to comply with regulations from Ph.Eur. and USP.
We have more than 20 years of experience analyzing different raw materials by means of a wide variety of techniques, which are also always widening.
Our specialized laboratories are equipped with state-of-the-art technologies and techniques, and our team of experienced professionals maintains the highest standards and regulatory requirements.
SERVICES
CMC & Quality Control Testing of Raw Materials
Our Equipment & Techniques
- U/HPLC with detectors: UV, DAD, FLD, RID, CAD, CD, EC, ELSD and MS
- GC with detectors: FID and MS
- Karl Fischer: Coulometric and volumetric.
- Spectrophotometer IR: With ATR
- Spectrophotometer UV-VIS
- ICP-MS: To determine the presence of metals
- Automatic Titrator: To perform acid-base and red-ox reactions in a large number of samples at once
- DSC: To determine both polymorphism and melting point
- Particle size distribution: To determine the profile of particle size of a given material by laser diffraction
- Conductimeter: To measure the conductivity of a given solution
- Refractometer: To measure the index of refraction of a given solution
- Polarimeter: To determine the polarization properties of samples
- Vacuum oven: For drying, curing, aging, vacuum embedding, and plating of samples
- Muffle: For high-temperature procedures
Why Choose KYMOS?
Services
Related services to Raw Material Testing
Microbiology
Laboratory including cleanroom with airlock technology and HEPA filters for testing of sterile and non-sterile APIs and drug products.
Elemental, Nitrosamines & Other Impurity Testing
Impurities testing of finished dosage forms, and identification of impurities in drug substances, excipients, manufacturing equipment, and reagents.
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