USP 233 Standard Test Method for Pharmaceutical Element Impurity

Medical Tests

USP 233 Standard Test Method for Pharmaceutical Element Impurity

EUROLAB laboratory provides testing and compliance service within the scope of USP 233 standard. This section describes the analytical procedures for elemental impurities, limits and evaluation of elemental impurities conforming to the limits described in elemental contaminants in nutritional supplements.

USP 233 Standard Test Method for Pharmaceutical Element Impurity

Two procedures and criteria are described for the acceptability of alternative procedures. Alternative procedures that meet the validation requirements described here are considered equivalent to procedures 1 and 2 for the purposes of this test. In addition, system standardization and conformity assessment should be performed using appropriate reference materials on the day of analysis. The testing requirement is specified in the general statements or in the individual monograph.

Determination of oxidation state, organic complex or combination is called speciation. Analytical procedures for speciation are not covered in this section, but examples can be found in USP-NF and elsewhere in the literature.

EUROLAB assists manufacturers with USP 233 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.

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