Why do we use 900 ml in dissolution apparatus?

Why do we use 900 ml in dissolution apparatus?

Most likely, the volume was lowered to 900mL to account for volume displacement from the product and stirring shaft. This gives some wiggle room in the test, so that the vessel doesn’t spill over during the dissolution.

How many dissolution apparatus are in USP?

4 standardized
General chapter <711> Dissolution includes 4 standardized apparatus: basket, paddle, reciprocating cylinder, and flow-through cell. Where specified in a monograph, USP dissolution tests are legal requirements.

How do you calibrate dissolution apparatus?

CALIBRATION FOR DISINTEGRATING TYPE PREDNISONE TABLETS 50 MG

1. Ensure that mains of instrument and supply are “ON”.
2. Set the time program for 30 minutes, temperature 37° C + 0.5° C and for 50 RPM.
3. Place 900 ml of deaerated water.
4. After achieving the temperature place one tablet in each bowl and start the time program.

How many types of USP dissolution apparatus are available?

seven different types
Currently, there are seven different types of dissolution apparatus defined in the United States Pharmacopeia (USP)-basket type, paddle type, reciprocating cylinder, flow through cell, paddle over disc, rotating cylinder, and reciprocating disc.

Why do we use 6 tablets for dissolution?

Six units are tested to provide the minimal statistical significance. *Mean & Standard deviation (SD)* of any in-process or finished product CQA represents *Accuracy & Precision* of any Statistically Contolled Stable Process or Method.

Why are prednisone tablets used for dissolution calibration?

Prednisone and Salicylic acid tablets USP were used for the calibration of dissolution test apparatus. Prednisone tablets were disintegration type and Salicylic acid tablets were non-disintegration type.

What is type 4 dissolution apparatus?

USP apparatus IV (Flow-through-Cell) The flow-through-cell apparatus (Apparatus I is consists of a reservoir for the dis¬solution medium and a pump that force dissolution medium through the cell holding the test sample. Flow rate ranges from 4 to 16 ml/min. six samples are tested during the dissolution testing.

What is the USP method of deaeration?

The USP method was used as a benchmark and other deaeration techniques were compared to this method. Various deaeration techniques (involving different degrees of complexity and expense) were found to be comparable to the USP method of deaeration (3,4).

Does deaeration prevent air from being trapped in pockets in dissolution?

Deaeration will not prevent air from being trapped in pockets in the dissolution apparatus. Air pockets have been discussed elsewhere (2) and are beyond the scope of this work. The USP recommends deaeration by a combina-tion of heating and vacuum filtration followed by vigorous stirring of the medium under vacuum (1).

How does the USP Dissolution toolkit work?

The protocol relies in large part on the information available in the USP Dissolution Toolkit. The Dissolution Toolkit describes techniques enhanced beyond those in <711> to control the operation and configuration of the test assemblies. The assumption in imposing these enhanced requirements is that the data will not suffer thereby.

What are some questions about dissolution test apparatus and protocols?

See below for answers to questions about dissolution test apparatus, performance verification testing, and protocols—sinkers, peak vessels, mini paddles, mesh size and more. 1. Can I use a sinker when the USP monograph does not specify one? Typically if a sinker is needed in a dissolution test the procedure will mention the fact.