Quality control of various products according to internationally recognized regulations and pharmacopeias is performed in our control lab. The lab operates with the support of the method alliance in our Competence Center Analytics and is an accredited GMP-compliant independent lab. |
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Applications: |
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- Pharmaceutical (example: active pharmaceutical ingredients, vitamins)
- Feed (example: enzymes)
- Food (example: aromachemicals)
- Cosmetics (example: sunscreens)
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Our computer-assisted quality control system encompasses: |
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- Sampling
- Performance and coordination of lab tests
- Evaluation of results
- Product batch release or rejection
- Certification
- Document creation and management
- Retention of records pursuant to FDA specifications § 21 CFR Part
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Our test methods: |
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The control lab is equipped for a wide range of chemical and physical test methods. |
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- Visual and potentiometric titration
- Karl-Fischer titration
- Determination of physical parameters
(density, refraction index, melting point, solidification point, etc.)
- Polarimetry (determination of optical activity)
- UV spectroscopy
- Thin layer chromatography
- Determination of loss on drying and sulfated ash
- Wet chemistry tests (e.g. pharmacopoeial)
- NIR spectroscopy
- Sensory and applications technology testing
- Particle measurement technology by laser diffraction
- Microscopic characterization of solids
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Other tests are delegated to other test labs that operate to the same high standards.
The control lab coordinates these tasks. |
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- All techniques performed by the Competence Center Analytics, e.g. chromatography
- Special techniques performed by external labs, e.g. microbiology
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Our specials: |
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- Support during audits by regulatory authorities and customers
- Conducting stress tests pursuant to ICH guidelines
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