USP 467 laboratory analysis

You want to analyze the solvent residues in your raw materials or finished products according to USP 467?

What is USP 467?

The USP is the United States Pharmacopoeia which provides control limits and criteria for the testing of volatile organic impurities in Treaty 467. Thus the impurities concerned are classified into three categories:

Solvents must not be used because of unacceptable toxicity or adverse environmental effects 
The use of solvents should be restricted due to inherent toxicities 
Solvents can be considered less toxic and present a lower risk to human health.

Therefore, solvents used in the manufacture or purification of pharmaceutical products are tested. This allows each company to determine the solvents used in production and to develop test procedures that meet their needs.

Why analyze residual solvents in your pharmaceutical products?

Residual solvents in pharmaceutical products are defined as volatile organic chemicals. They are used or produced in the manufacture of pharmaceutical products or drug substances (benzene, acetone, cyclohexane, toluene, 1,4-dioxane…).

Solvent residues can be not only toxic but also detrimental to the manufacturability and stability of the finished product. Because of the consequences on the quality of the product, specifications have been set at international level for each solvent.

Therefore, it is essential to analyze your products to ensure that they comply with the relevant regulations.

FILAB supports you in the analysis of your products according to USP 467

For more than 20 years, our FILAB laboratory has had the experience and specific analytical equipment to support pharmaceutical companies in the analysis of residual solvents in accordance with USP 467, through tailor-made support.

The support of an expert laboratory in solvent analysis such as FILAB enables us to better understand the strategic issues and changes in the pharmaceutical sector.

The FILAB laboratory supports pharmaceutical companies in the search for residual solvents in pharmaceutical products and substances, thanks to its GC-MS and HS-GC-MS equipment.

The positive aspects of FILAB

  • A highly qualified team

  • Responsiveness in responding to and processing requests

  • A complete analytical park of 2100m²

  • Tailor-made support

Caroline KURZAWA R&D Project Engineer
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