Pharma
PHARMACEUTICAL QUALITY CONTROL
In Chelab S.r.l facility we perform for other companies chemical - physical quality controls, biological and microbiological analysis on sterile, not sterile and biological medicinal products, vegetal products, homeopathic products, pharmacologically active raw materials, excipients and intermediate products.
The tests are performed in compliance with GMP by the application of analytical summaries (EP, BP, USP, JP, etc.), methods by the customer, or internally developed methods.
Physical - chemical tests
- Assay
- Impurities and related substances
- Limit tests, identification and qualitative tests
- Residual analysis
- Residual solvents
- Metals
- Pesticides
- Aflatoxins
- Polymorphism
- Dissolution test
- Disgregation tests
- Granulometric distribution
- Packaging control (leachables & extractables)
- Chemical controls on drugs and psychotrope substances or in medicinal products (Ministerial authorization nr. 12644)
- Others
Microbiological and biological tests
- Sterility tests
- Microbiological tests for patogens, bacteria, moulds and yeasts
- Genotypic identification of moulds, yeast and bacteria
- Virology
- Sub-visible particle counting
- Qualitative and quantitative analysis of endotoxins
- Preservative efficacy testing
- Analytical method validation
- Microbiological analysis of water, surfaces and air
- Microbiological controls on drugs and psychotrope substances or in medicinal products (Ministerial authorization nr. 12644)
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