Скачать или смотреть Dissolution Test Procedure of Omeprazole in QC Lab 2020 in Urdu/Hindi

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what is dissolution test?
Dissolution is the process in which a substance forms a solution. Dissolution testing measures the extent and rate of solution formation from a dosage form, such as tablet, capsule, ointment, etc. The dissolution of a drug is important for its bioavailability and therapeutic effectiveness. Dissolution and drug release are terms used interchangeably.

To properly evaluate the dissolution of drug products, it is critical for procedures to be standardized. This standardization helps to show consistent quality in production and may serve as a predictive measure of efficacy.
A dissolution test uses an apparatus with specific test conditions in combination with acceptance criteria to evaluate the performance of the product.
There are two stages of Dissolution test
1.acidic Stage
2. Buffer Stage
Method A—
Procedure (unless otherwise directed in the individual monograph) .
ACID STAGE :
Place 500 mL of 0.1 N hydrochloric acid in the vessel, and assemble the apparatus.
Allow the medium to equilibrate to a temperature of 37 ± 0.5 . Place 100mg dosage unit in the apparatus,
cover the vessel, and operate the apparatus at the specified rate given in the monograph .
Time 2h
!00 rpm
After 2 hours of operation in 0.1 N hydrochloric acid, withdraw an aliquot of the fluid, and proceed
immediately as directed under Buffer Stage.
Perform an analysis of the aliquot using a suitable assay method. The procedure is specified in the
individual monograph.
BUFFER STAGE — [NOTE—Complete the operations of adding the buffer and adjusting the pH within 5
minutes.]
With the apparatus operating at the rate specified in the monograph , add to the fluid in the
vessel 900mL of 0.20 M tribasic sodium phosphate that has been equilibrated to 37 ± 0.5 . Adjust, if
necessary, with 30% hydrochloric acid or 2 N sodium hydroxide to a pH of 6.8 ± 0.05. Continue to
operate the apparatus for 30 minutes, or for the specified time given in the individual monograph .
At the end of the time period, withdraw an aliquot of the fluid, and perform the analysis using a suitable
assay method. The procedure is specified in the individual monograph. The test may be concluded in
a shorter time period than that specified for the Buffer Stage if the requirement for the minimum
amount dissolved is met at an earlier time.

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