Contents Uniformity (Weight or Volume) of Packaged Dosage Forms

The following tests and specifications apply to oral dosage forms and preparations intended for topical use that are packaged in containers in which the labeled net quantity is not more than 100 g or 300 ml or 1000 units, as the case may be. For higher labeled quantities the test and limits given in the standards of Weights and Measures (Packaged commodities) Rules, 1977 may be followed.

Ointments, Creams, Pastes, Granules and Powders for Oral Liquids

Select a sample of 10 filled containers and remove any labeling that might be altered in weight while removing the contents of the containers. Clean and dry the outer surfaces of the containers and weigh each container. Remove quantitatively the contents from each container. If necessary, cut open the container and wash each empty container with a suitable solvent, taking care to ensure that the closure and other parts of the container are retained. Dry and again weigh each empty container together with its parts which may have been removed. The difference between the two weights is the net weight of the contents of the container.

The average net weight of the contents of the 10 containers is not less than the labeled amount and the net weight of the contents of any single containers is not less than 91 % and not more than 109 % of the labeled amount where the labeled amount is 50 g or less, or not less than 95.5 % and not more than 104.5 % of the labeled amount where the labeled is more than 50 g but not more than 100g.

If this requirement is not met, determine the net weight of the contents of 10 additional containers. The average net weight of the contents of the 20 containers is not less than the labeled amount, and the net weight of the contents of not more than 1 of the 20 containers is less than 91 % or more than 109 % of the labeled amount where the labeled amount is 50 g or less than 95 % or more than 104.5 % of the labeled amount is more than 50 g but not more than 100 g.
Related: Uniformity of Weight of Single-Dose Preparations

Liquids and suspensions

Viscous preparations- Select a sample of 10 filled containers and determine the weight of the contents of each container as directed under Ointments, Creams, Pastes, Granules and Powders for Oral Liquids. Determine the weight per ml and calculate the net volume of the contents of each container.

Non-viscous and free-flowing liquids- Pour completely the contents of each container into calibrated volume measures of the appropriate size and determine the volume of the contents of the 10 containers.

The average net volume of the contents of the 10 containers is not less than the labeled amount, and the net volume of the contents of any single containers is not less than 91 % and not more than 109 % of the labeled amount where the labeled amount is 50 ml or less, or not less than 95.5 % and not more than 104.5 % of the labeled amount where the labeled amount is more than 50 ml but not more than 200 ml, or not less than 97 % but not more than 103 % of the labeled amount where the labeled amount is more than 200 m1 but not more than 300 ml, If this requirement is not met, determine the net volume of the contents of 10 additional containers. 

The average net volume of the contents of the 20 containers is not less than the labeled amount, and the net volume of the contents of not more than 1 of the 20 containers is less than 91 % or more than 109 % of the labeled amount where the labeled amount is 50 ml or less or less than 95.5 percent or more than 104.5 % of the labeled amount where the labeled amount is more than 50 ml but not more than 200 ml or less than 97 % or more than 103 % of the labeled amount where the labeled amount is more than 200 ml but not more than 300 ml.

Capsules, Pessaries, Suppositories and Tablets

Select a sample of 10 containers and count the number of capsules, pessaries, suppositories or tablets in each container. The average number of the contents in the 10 containers is not less than the labeled amount and the number in any single container is not less than 98 % and not more than 102 % of the labeled amount. If this requirement is not met, count the number of the contents in 10 additional containers. The average number in the 20 containers is not less than the labeled amount, and the number is not more than 1 of the 20 containers is less than 98 % or more than 102 % of the labeled amount.

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