DETERMINATION OF VOLUME OF INJECTION IN CONTAINERS
This section is harmonized with the corresponding texts of the European Pharmacopoeia and/or the Japanese Pharmacopoeia. These pharmacopeias have undertaken not to make any unilateral change to this harmonized section. A portion of the present text (see below) is national USP text, and therefore not part of the harmonized text; it is marked with symbols (⧫⧫) to specify this fact.
Suspensions and emulsions must be shaken before withdrawal of the contents and before the determination of the density. Oily and viscous preparations may be warmed according to the instructions on the label, if necessary, and thoroughly shaken immediately before removing the contents. The contents are then cooled to 20°–25° before measuring the volume. ⧫Sterile solid formulations must be constituted according to labeled directions before removing the contents. Contents are then to be measured following the procedures for suspensions, emulsions, or solutions, as appropriate.⧫
Single-Dose Containers
Determine an appropriate number of containers to be tested, based on the number of units available and a suitable statistical approach. Following the instructions on the label, extract the total contents of each container selected into a suitable dry syringe fitted with a suitable needle, e.g., a 21-gauge needle NLT 2.5 cm (1 inch) in length. Expel any air bubbles from the syringe and needle, taking care not to spill out any product. Then discharge the contents of the syringe, without emptying the needle, into acalibrated dry cylinder (graduated to contain rather than to deliver the designated volumes) of such sizecapacity that the volume to be measured occupies at least 40% of its graduated volume. Alternatively, the volume of the contents in milliliters may be calculated as the mass, in grams, divided by the density. The volume in each container tested is NLT the nominal volume.
Multi-Dose Containers
For Injections in multiple-dose containers labeled to yield a specific number of doses of a stated volume, select 1 container and proceed as directed for single-dose containers, using the same number of separate syringe assemblies as the number of doses specified. The volume extracted into each syringe is such that it delivers NLT the dose stated on the label.
Injections in Cartridges or Prefilled Syringes
Determine an appropriate number of containers to be tested, based on the number of units available and a suitable statistical approach. If necessary, fit the containers with the accessories required for their use (needle, piston, syringe) and transfer the entire contents of each container without emptying the needle into a dry tared beaker by slowly and continuously depressing the piston. Calculate the volume, in milliliters, by calculating the mass, in grams, divided by the density.
The volume measured in each of the containers tested is NLT the nominal volume.
Source from USP and Please refer to USP for details:https://online.uspnf.com/uspnf/document/2_GUID-36AE7C6F-5983-4F42-9426-24574CEDB1A4_10101_en-US?source=TOC
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