united states pharmacopeia
New edition of the United States Pharmacopeia
Refractometer-related changes
USP <831> released.
On December 1, 2023, the new edition of USP 831 was officially releasedchangeThere are four points as follows.
Device confirmation.
Implementation of IQ, OQ and PQ.
pharmacopeia
Anton PaarPharmaceutical industry expertsWhat's changed:
The new edition of the Pharmacopoeia specifies that refractometers require three certifications: Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ).
qualification of refractometers can be divided into three elements: installation qualification (iq), operational qualification (oq), and performance qualification(pq). for further discussion, see analytical instrument qualification 〈1058〉.”
Anton Paar Solutions:
Anton Paar's refractometers have a standardized 4 Q - Pharma Qualification Package (PQP) that covers IQ, OQ and PQ in its entirety"Eligibility Determination Program" ，"Risk analysis"with"Eligibility Determination Instructions"certification service content.
Temperature verification.
pharmacopeia
Anton PaarPharmaceutical industry expertsWhat's changed:
The new edition of the pharmacopoeia clarifies that the OQ of the refractometer should verify the temperature control of the sample; At the specified temperature, the reading is accurate to at least 01º。
the oq for the refractometer should verify the temperature control of the sample…”
at the prescribed temperature, with readings accurate to at least ±0.1º.”
Anton Paar Solutions:
Anton Paar's refractometer ABBEMAT T-Check has an on-site temperature calibration and correction function.
The most accurate refractive index measurement at the right temperature
Temperature correction reports in the audit trail for full traceability
The temperature calibration report contains all relevant information and details
Provide fully traceable data (to meet the requirements of the pharmaceutical qualification process).
Accuracy, repeatability,
Certified Reference Materials
manufacturing
Anton PaarPharmaceutical industry expertsWhat's changed:
The new edition of the Pharmacopoeia clarifies that the refractometer needs to meet the following requirements:
The instrument accuracy is at least 00001
The extended uncertainty of the certified reference material used must be equal to or better than 0001
A minimum of six replicate measurements should be performed for each certified reference material with results equal to or less than the repeatability performance specifications specified by the instrument (as provided by the manufacturer).
the apparatus should provide refractive index readings to ±0.0001…”
the certified reference materials used must h**e an equal or better expanded uncertainty than ±0.001.”
verify the repeatability of the refractometer by measuring at least two different certified reference materials covering the intended operational range of the instrument. perform at least six replicate measurements of each certified reference material. the result should be equal to or less than the stated repeatability performance specification of the instrument (as provided by the manufacturer)”
Anton Paar Solutions:
Anton Paar refractometers are used for routine quality control measurements of refractive index and concentration with an accuracy of +-00001 nd, far beyond the standard.
Abbemat is fully capable of using customer reference samples in accordance with USP 831 to test accuracy and repeatability.
Periodic calibration requirements.
pharmacopeia
Anton PaarPharmaceutical industry expertsWhat's changed:
The new edition of the pharmacopoeia clarifies that the PQ of the refractometer should be carried out regularly or currently.
pq includes two stages: periodic instrument calibration and performance evaluation. instrument calibration should be performed periodically according to the instrument manufacturer’s instructions. the second stage of pq evaluation should be conducted at regular intervals or on day of use by verifying the refractive index of suitable reference materials.”
Anton Paar Solutions:
Anton Paar's refractometer ABBEMAT has a self-check method based on the built-in functions of the software, which is convenient, fast and fully compliant with PQ regulations.
Get to know Anton Paar's Abbemat refractometers
"Fully compliant with pharmaceutical industry regulations"
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