สารบัญ

4.21 DELIVERABLE VOLUME

      The following tests are designed to provide assurance that oral solutions and suspensions will, when transferred from the original container, deliver the volume of dosage form that is declared on the label of the article. These tests are applicable to products labelled to contain not more than 250 ml, whether supplied as liquid preparations or liquid preparations that are constituted from solids upon the addition of a designated volume of a specific diluent. They are not required for an article packaged in single-unit containers when the monograph includes “Uniformity of Dosage Units” (Appendix 4.28).

      For the determination of deliverable volume, select not fewer than 30 containers, and proceed as follows for the dosage form designated.

      ORAL SOLUTIONS, ORAL SUSPENSIONS AND SYRUPS Mix the contents of 10 containers individually.

      POWDERS THAT ARE LABELLED TO STATE THE VOLUME OF ORAL SOLUTION OR ORAL SUSPENSION THAT RESULTS WHEN THE POWDER IS CONSTITUTED WITH THE VOLUME OF DILUENT STATED IN THE LABELLING Constitute 10 containers with the volume of diluent stated in the labelling accurately measured and mix.

¹Thai Pharmacopoeia Vol. I Part 2, Bangkok, Department of Medical Sciences, Ministry of Public Health, 1993, p. 1075.

      PROCEDURE

      SINGLE-UNIT CONTAINERS Gently pour the contents of each container into a separate dry graduated cylinder of a rated capacity not exceeding two and a half times the volume to be measured and calibrated “to contain”, being careful to avoid the formation of bubbles and allowing them to drain for a period not to exceed 5 seconds unless otherwise specified in the monograph. When free from air bubbles, measure the volume of each mixture. Alternatively, in the case of products of low volume, it can be computed by discharging into a suitable tared container (allowing drainage for not more than 5 seconds), by determining the weight by difference and by computing the volume after determining the apparent density. The average volume of solution, suspension, or syrup obtained from the 10 containers is not less than 100 per cent and the volume of no container is less than 95 per cent and more than 110 per cent of the volume declared in the labelling. If A, the average volume is less than 100 per cent of that declared in the labelling, but the volume of no container is less than 95 per cent of the labelled amount, or B, the volume of not more than one container is less than 95 per cent, but is not less than 90 per cent of the labelled volume, perform the test on 20 additional containers. The average volume of solution, suspension, or syrup obtained from the containers is not less than 100 per cent of the volume declared in the labelling; and the volume of solution, suspension, or syrup obtained from not more than one of the 30 containers is less than 95 per cent, but not less than 90 per cent of that declared in the labelling; and is more than 110 per cent, but not more than 115 per cent of that declared on the labelling.

      MULTIPLE-UNIT CONTAINERS Gently pour the contents of each container into a separate dry graduated cylinder of a rated capacity not exceeding two and a half times the volume to be measured, and calibrated “to contain”, being careful to avoid the formation of bubbles and allowing them to drain for a period not to exceed 30 minutes unless otherwise specified in the monograph. When free from air bubbles, measure the volume of each mixture. The average volume of solution, suspension, or syrup obtained from the 10 containers is not less than 100 per cent and the volume of no container is less than 95 per cent of the volume declared in the labelling. If A, the average volume is less than 100 per cent of that declared in the labelling, but the volume of no container is less than 95 per cent of the labelled amount, or B, the volume of not more than one container is less than 95 per cent, but is not less than 90 per cent of the labelled volume, perform the test on 20 additional containers. The average volume of solution, suspension, or syrup obtained from the containers is not less than 100 per cent of the volume declared in the labelling; and the volume of solution, suspension, or syrup obtained from not more than one of the 30 containers is less than 95 per cent, but not less than 90 per cent of that declared in the labelling.