Standard Interpretation | The latest interpretation of USP refraction in the United States Pharmacopeia

author：Anton Paar 2024-01-30 16:02:00

United States Pharmacopeia

New edition of the United States Pharmacopeia

Refractometer-related changes

USP <831> issued

On December 1, 2023, the new edition of USP 831 was officially released, and the new pharmacopoeia has the following four changes to the content related to refractive measurement.

Device confirmation

Implementation of IQ, OQ and PQ

PHARMACOPEIA

Anton Paar

Pharmaceutical industry experts

What'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's solution:

Anton Paar's refractometers have a standardized 4 Q-Pharma Qualification Package (PQP) that covers IQ, OQ and PQ, as well as certification services such as the Qualification Program, Risk Analysis and Qualification Statement.

Temperature verification

PHARMACOPEIA

Anton Paar

Pharmaceutical industry experts

What's changed:

The new edition of the Pharmacopoeia specifies that the OQ of the refractometer should verify the temperature control of the sample, with readings accurate to at least ±0.1º at the specified temperature.

“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's solution:

The Anton Paar refractometer Abbemat T-Check features on-site temperature calibration and correction.

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 full traceability of data (to meet the requirements of the pharmaceutical qualification process)

Accuracy, repeatability,

Certified Reference Materials

MANUFACTURING

Anton Paar

Pharmaceutical industry experts

What's changed:

The new edition of the Pharmacopoeia clarifies that the refractometer needs to meet the following requirements:

The instrument accuracy is at least ±0.0001
The Certified Reference Material used must have an extended uncertainty equal to or better than ±0.001
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 have 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's solution:

Anton Paar's refractometers are used for routine quality control measurements of refractive index and concentration with an accuracy of +/-0.0001 nD, which is well beyond the standard.

Abbemat is fully capable of using customer reference samples in accordance with USP 831 to determine accuracy and repeatability.

Periodic calibration requirements

PHARMACOPEIA

Anton Paar

Pharmaceutical industry experts

What's changed:

The new edition of the Pharmacopoeia clarifies that the PQ of the refractometer should be performed 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's solution:

Anton Paar's refractometer Abbemat has a self-check based on the built-in software function that is quick and easy and fully PQ compliant.

Get to know Anton Paar's Abbemat refractometers

"Fully compliant with pharmaceutical industry regulations"

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Standard Interpretation | The latest interpretation of USP refraction in the United States Pharmacopeia

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