How to know whether your UV/VIS Verification methods conform to USP 857 Standards

The United States Pharmacopeial Convention 857 or USP 857 necessitates that all equipment imported into the USA by pharmaceutical companies in the country should mandatorily satisfy their set of requirements. This mandate was established and brought into play on 1st May 2016 and continues to affect all vendors in this field of operation.

The USP 857 standards contain very specific criteria for verification of wavelength accuracy and photometric accuracy of concerned equipments. There are also new requirements suggested for spectral resolutions and stray light which wasn't present previously. Apart from this, they have also laid out very specific requirements for filters for each verification that is conducted. These USP requirements are more in tandem with International Pharmacopeial requirements. All new and existing laboratories in the USA are expected to conform to these new set standards and actively involve in testing these changes which are now recognized officially.

The measurements obtained should be suitable in terms of precision, accuracy, linearity, range, robustness, quantitation limits, specificity and detection. The quality of your test results using laboratory equipment is deemed to be satisfactory and accurate, only if they meet these conditions. Nevertheless, it is also essential to consider other factors like properly planned analytical methods, trained analysts, error-free experimental setups and performance level of the system under consideration to ensure quality and accuracy of test results.

Difference between previous USP Standards and USP 857 and its implications

The original USP guidelines did not set out specific guidelines with regard to laboratory operations and techniques, although it did suggest general principles. The current revision addresses all these relevant factors and provides a very thorough and specific format for testing and verification of all the guidelines, that all companies are expected to adhere to.

Impact of this on your test results and lab operations

USP qualification kits allow you to check for compliance with USP 857 criteria. These kits contain all the required reference materials, so suitable parameter verification can be carried out effectively and on-time.

Conforming to the currently set out standards will ensure that all labs will have a uniform concept and follow a common format, that eliminates chances of error. Consistency in the approach will improve use and help to create a uniform standard across the industry. This will establish reasonable and meaningful standards in the long run which are scientifically sound and appropriately acceptable for the given conditions.

To verify the absorbance obtained by your spectrophotometer use Hellma Certified Reference Material from FirstSource Laboratory Solutions.