Why Dissolution Test Apparatus Calibration with Salicylic Acid Tablets was Stopped? : Pharmaceutical Guidelines

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Why Dissolution Test Apparatus Calibration with Salicylic Acid Tablets was Stopped?

Know the reasons behind the withdrawal of the salicylic acid tablets from the dissolution test apparatus 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.

Dissolution test apparatus calibration is described in General Chapter DISSOLUTION <711> but the calibration with Salicylic acid tablets USP is no longer available now because USP had withdrawn the Salicylic acid calibration part on December 01, 2009.

Reference StandardsFDA published the change in dissolution test apparatus calibration in January 2010 in cGMP guideline for calibration of dissolution apparatus while USP published a toolkit for calibration for the dissolution test apparatus in March 2010 describing the dissolution test apparatus calibration procedure only with Prednisone tablets. 

But FDA and USP do not describe the requirement for the change.

Following are some possible reasons for the withdrawal of Salicylic acid tablets from the dissolution test apparatus calibration.

1. Salicylic acid tablets were non-disintegrating and uncoated tablets but practically uncoated and non-disintegrating formulations are very rare, so there was no requirement for the calibration the dissolution apparatus with the non-disintegrating tablets.

2. Salicylic acid tablets are unstable and stuck together. Due to this, these tablets violates the quality of analytical standard.
Therefore the Salicylic acid tablets had withdrawn from the calibration of dissolution test apparatus.

Suggest below for comments if you have any opinion on the change.







Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
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3 comments: Post Yours! Read Comment Policy ▼

  1. i think, there might be a reason for withdrawal of salicylic acid tablets, because of those Dissolution run time was around 24hrs. To reduce time and minimise analytical & possible errors, Prednisone tablets proposed, whose run completed within 30mins in front of analyst.

    ReplyDelete
  2. Different between master file and master formula

    ReplyDelete


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