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“I would just like to say how pleased I was with the service carried out on our instruments. The service was carried out in an effective and timely manner. The paperwork is excellent and it is logical and well presented.”
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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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