Analysis according to the Pharmacopoeia​

The 6NAPSE Group carries out pharmaceutical analyzes according to the Pharmacopoeia. We control the quality of pharmaceutical products and medicines.

Why have your medical products analyzed according to the Pharmacopoeia?

The Pharmacopoeia is a regulatory work addressed to pharmaceutical manufacturers and health professionals. On the one hand, it defines the criteria for the purity of raw materials or preparations used in the manufacture of medicines or even their containers. On the other hand, it includes the analysis methods to be used to ensure quality control.

There are several valid pharmacopoeias:

• National Pharmacopoeia: including French Pharmacopoeia prepared and published by ANSM, United States Pharmacopoeia (USP), Japanese Pharmacopoeia, etc.
• European Pharmacopoeia prepared and published by the EDQM (European Directorate for the Quality of Medicines & Healthcare)
• International Pharmacopoeia published globally by WHO

Pharmacopoeias are used during control tests for the marketing of the pharmaceutical product. Thus, these regulations ensure compliance of drugs or containers.

Pharmaceutical analysis laboratory according to the Pharmacopoeia​

The laboratories of the 6NAPSE Group have been carrying out expertise for the Pharmaceutical Industry on its products for years. We thus ensure the analysis and control of drugs, pharmaceutical products and containers.

• Custom chemical analysis on pharmaceutical products according to the pharmacopoeia
• Elemental analysis ICH-Q3D (USP 233): detection of elemental impurities and measurement of the content of heavy metals within pharmaceutical products
• Characterization of contaminations: identification of the morphology, nature and source of the contamination within the framework of analysis of deposits and particles
• Characterization of powders and particle size analysis
• Aging tests on products
• Validation of vaccine safety
• Validation of pharmaceutical packaging throughout the logistics cycle
• Expertise for the pharmaceutical industry

Short standard deadlines and possibilities of emergencies.