Mass Uniformity Of Single Dose Preparations

  • For tablet:

    • Weigh individually twenty units taken at random or, for single-dose preparations presented in individual containers the contents of twenty units, and determine the average mass.
    • Not more than two of the individual masses deviate from the average mass by more than the percentage deviation shown in table 1 and none deviates by more than twice that percentage.
  • Powders for parenteral use:

    • Remove any paper labels from a container and wash and dry the outside.
    • Open the container and without delay weigh the container and its contents.
    • Empty the container as completely as possible by gentle tapping, rinse it if necessary with water R and alcohol R and dry at 100 °C to 105 °C for 1 h.
    • If the nature of the container precludes heating at this temperature, dry at a lower temperature to constant mass.
    • Allow to cool in a desiccator and weigh.
    • The mass of the contents is the difference between the weighing.
    • Repeat the procedure with another 19 containers.

 

  • Uniformity of weight (mass) of delivered doses from multi-dose containers:

    • The following test is intended for oral dosage forms such as granules, powders for oral use and liquids for oral use, which are supplied in multi-dose containers fitted with an integral measuring device.
    • Weigh individually twenty doses taken at random from one or more containers with the integral measuring device.
    • Determine the individual and average weights (masses).
    • Not more than two of the individual weights (masses) deviate from the average weight (mass) by more than 10% and none deviates by more than 20%.