Revision of US Pharmacopoeia <831> Refractive Index
Anton Paar UK
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In December 2023 the US Pharmacopoeia released an updated version of their monograph <831>. This changed the requirements for compliance in many key areas including:
Any instrument installed that is not shown to meet the new requirements will automatically lose its qualified status at the next qualification due date.
This represents a big risk for users of refractometers in regulated environments, but Anton Paar has some elegant solutions to help maintain compliance.
Our PQP equipment qualification documentation and requalification documentation is widely regarded as the best available on the market. The 4Q-model-based package includes all required information and tests to meet the requirement of <1058> with the addition of:
• Traceability Matrix, Customer modifiable SOP template, 21CFR11 checklist, Deviation list and Final qualification summary report.
Anton Paar is the only supplier of Refractometers to have a true solution for temperature verification.
• The unique patented T-Check device measures the surface temperature of the measuring prism directly. Other suppliers must use indirect means to estimate temperature accuracy via reference materials, which is inherently inaccurate and slower.
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All refractometer models from Anton Paar meet the accuracy requirement of +/- 0.0001nD, and many of them comfortably exceed it.
• Our certified reference materials are the most accurate available with an expanded uncertainty of just +/- 0.00001nD
• A wide range of standards is available to cover a wide application range. These are certified for use at three different temperatures.
Verification of repeatability is already part of the Anton Paar qualification documentation
• Many of the models available feature built in statistics analysis to make verification a fast and easy process.
If you are impacted by this change, or if you are looking to acquire a refractometer for use in a regulated environment, talk to the experts and get the best advice. Arrange a consultation.
During February and March 2024 we are offering some special deals on all Abbemat refractometers purchased with qualification, or for requalification of your existing refractometers.