Add the following:
697 CONTAINER CONTENT FOR INJECTIONS
Official May 1, 2016
Each container of an injection contains sufficient excess to allow withdrawal of the labeled quantity of drug (see Pharmaceutical Dosage Forms 1151, Excess Volume in Injections). Such withdrawal shall be performed according to labeled directions, if provided.

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— Select 1 container if the volume of the container is 10 mL or more, 3 containers if the nominal volume is more than 3 mL and less than 10 mL, or 5 containers if the nominal volume is 3 mL or less. Take up individually the total contents of each container selected into a dry syringe of a capacity not exceeding three times the volume to be measured and fitted with a 21-gauge needle NLT 2.5 cm (1 inch) in length. Expel any air bubbles from the syringe and needle, and then discharge the contents of the syringe, without emptying the needle, into a standardized, dry cylinder (graduated to contain rather than to deliver the designated volumes) of such size that the volume to be measured occupies at least 40% of its graduated volume. Alternatively, the volume of the contents in mL may be calculated as the mass, in g, divided by the density. For containers with a nominal volume of 2 mL or less, the contents of a sufficient number of containers may be pooled to obtain the volume required for the measurement, provided that a separate, dry syringe assembly is used for each container. The contents of containers holding 10 mL or more may be determined by means of opening them and emptying the contents directly into the graduated cylinder or tared beaker.
The volume is NLT the nominal volume in the case of containers examined individually or, in the case of containers with a nominal volume of 2 mL or less, is NLT the sum of the nominal volumes of the containers taken collectively.
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 is such that each syringe delivers NLT the stated dose.
Injections in Cartridges or Prefilled Syringes— Select 1 container if the volume is 10 mL or more, 3 containers if the nominal volume is more than 3 mL and less than 10 mL, or 5 containers if the nominal volume is 3 mL or less. 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 constantly depressing the piston. Determine the volume, in mL, calculated as the mass, in g, divided by the density.
The volume measured for each of the containers is NLT the nominal volume.
Large-Volume Intravenous Solutions— For intravenous solutions, select 1 container. Transfer the contents into a dry measuring cylinder of such a capacity that the volume to be determined occupies at least 40% of the nominal volume of the cylinder. Measure the volume transferred.
The volume is NLT the nominal volume.USP38
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General Chapter Desmond G. Hunt, Ph.D.
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USP38–NF33 Page 478
Pharmacopeial Forum: Volume No. 38(6)