USP 232 Standard Test Method for Elemental Impurities, Limits

Medical Tests

USP 232 Standard Test Method for Elemental Impurities, Limits

EUROLAB laboratory provides testing and compliance services within the scope of the USP 232 standard. This general section specifies the limits of the amounts of essential impurities in pharmaceutical products.

USP 232 Standard Test Method for Elemental Impurities, Limits

Elemental impurities include catalysts and environmental pollutants that may be found in drug substances, excipients or drug products. These impurities may occur naturally, be added intentionally, or occur unintentionally (for example, through interactions with processing equipment and the container closure system).

If elemental impurities are known to be present, added or have the potential to enter, assurance of compliance with specified levels is required. A risk-based control strategy may be appropriate when analysts determine how to ensure compliance with this standard.

Due to the ubiquitous nature of arsenic, cadmium, lead and mercury, they should (at least) be considered in the risk assessment. Regardless of the approach used, the specified limits for all drug products must be followed, unless specified otherwise in a separate monograph or excluded in the third paragraph of this entry.

EUROLAB assists manufacturers with USP 232 test compliance. Our test experts, with their professional working mission and principles, provide you, our manufacturers and suppliers, the best service and controlled testing process in our laboratories. Thanks to these services, businesses receive more effective, high-performance and quality testing services and provide safe, fast and uninterrupted service to their customers.

Get Offer Now

To get an appointment, to get more detailed information or to request an evaluation, you can ask us to fill in our form and reach you.

Whatsapp