Content Handbook P

Reason for Revision

Sample preparation has been harmonized, temperature requirements have been changed from 30 °C to 25 ± 5 °C, the range of applicable concentrations has been set from 0.1 to 10% and the calculations for water soluble bags has been updated.
The concept of performing a “Re-Suspensibility” was introduced as an extension of the method. Some editorially changes have been made and obsolete references have been removed.

Where same conditions are used, results obtained with MT 184.1 are equivalent to those obtained with MT 184. MT 184.1 supersedes MT 184

Outline of method

A suspension of the formulation in Standard Water, is allowed to remain undisturbed for a specified time at ambient temperature before the top 9/10ths are drawn off and the remaining 1/10th is assayed. The suspensibility is calculated as the percentage of particles remaining suspended.

Scope

 This method is intended to determine the suspensibility which is defined as the percentage of one or more active ingredient(s) remaining in suspension after a given time. The method is applicable to formulations forming suspensions on dilution with water at sample concentrations between 0.1% and 10%.