Raw Material Testing

GMP testing for APIs and excipients of pharmaceutical use.

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 maintain the highest standards and regulatory requirements.

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SERVICES

CMC & Quality Control Testing of Raw Materials

Analytisches CRO HPLCs

Our Equipment for General QC of Raw Materials

  • 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

Our Specific Equipment for Raw Material Testing

  • 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 poliphormism 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 light beams and samples
  • Vacuum oven: For drying, curing, aging, vacuum embedding, and plating of samples
  • Muffle: For high-temperature procedures
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Team Discussion

Why Choose KYMOS?

  • Regulatory Excellence:

    • GMP-certified, FDA and EMA-inspected laboratories
    • Full compliance with USP and Ph.Eur. guidelines
  • Global Trust:

    • Reliable partner for leading pharmaceutical companies worldwide.
    • Proven expertise in raw material quality control
  • Advanced Analytical Capabilities:

    • Proven expertise in all the techniques and instrumentation described.
    • Cutting-edge technologies and highly trained laboratory staff.

Services

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Laboratory including cleanroom with airlock technology and HEPA filters for testing of sterile and non-sterile APIs and drug products.

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Impurities testing of finished dosage forms, and identification of impurities in drug substances, excipients, manufacturing equipment, and reagents.

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Method Development, Validation and Transfer

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

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Quality Control of Small Molecules

Analytical tests for APIs, excipients, intermediate products, finished products, packaging materials and process environment samples.

Contact

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