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Performance Verification PVT

Labserv provide chemical test (PVT) for Apparatus 1 and 2 as described in USP General Chapter <711>.

The USP chemical test (PVT) is also a test of the entire procedure, including the operator, the instrumentation and the “reference standard” tablets.

Many variables effect PVT results, not just the apparatus, and in-house PVT failures are common.
Labserv engineers have years of experience in performing PVT to a consistently high standard to mitigate against all the common causes of failures during the procedure.

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NOTE: Leading causes of failures >> Preparation of reference standard solution – Vibration – Deaeration method and execution – Centering and “hemispherical bottom” – Condition and temperature of the vessels, baskets or paddles – Standardised tablet introduction and uniform, repeatable sample location accuracy – Filtration method, execution and timing – UV-Vis method, accuracy, execution

Labserv USP trained & certified technicians will ensure instruments comply with USP <711> and follow best practices using certified tools.

 

The Performance Verification Test:
Dissolution Procedure
– Deaerate the medium
– Deliver the media to the vessels
– Deliver the dosage
– Sample withdrawal
– Sample filtration, 0.45 µm PVDF syringe filter

Analytical Procedure
– Prepare two reference standard solutions
– UV measurements
– Single -Stage or Two –Stage
– Use the USP PVT calculation tool

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Mechanical Qualification Testing MQT

In most cases, Mechanical qualification is performed prior to PVT. Rigorous mechanical alignments and adjustments are regularly required to aid a PVT pass;

Our MQT provides 100% evaluation of the following in accordance with <711>: Find out more here >>

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