Deliverable volume testing checks that a liquid container delivers the volume stated on its label. USP <698> applies to oral solutions, suspensions and similar liquids labelled to contain 250 mL or less. The test matters because a container that under-delivers gives the patient less than the labelled dose, even when the fill looks correct on paper.
The calculator converts each measured volume into a percentage of the labelled volume and applies the acceptance windows for multiple-unit and single-unit containers at Stage 1 (10 containers) and Stage 2 (30 containers).
Multiple-unit bottles labelled 100 mL, with 10 containers measured at 101.2, 100.8, 102.0, 99.9, 101.5, 100.4, 101.0, 100.6, 100.2 and 101.9 mL.
The average is at or above 100% and no container is below 95%, so Stage 1 passes. If the lowest container had been 92.0 mL, it would be in the borderline zone (90–95%) and Stage 2 testing would be needed.
Record the labelled volume, the container type and whether the product is multiple-unit or single-unit before you start, because the acceptance window depends on that classification and cannot be corrected afterwards. Use measuring equipment suited to the volume, such as calibrated graduated cylinders, and read the meniscus at eye level.
Allow suspensions and viscous liquids to drain for the time given in the method, and keep the technique the same for every container. Differences in pouring speed or draining time are a frequent cause of results that drift between analysts.
If a result is borderline, do not repeat single containers until one passes. Follow the staged procedure, document each stage in the same record and pool the data as the chapter requires. Trending the average and the lowest container across batches helps production spot a filling problem long before a failure occurs.
The checks on this page relate to the documents below. Standards are revised from time to time, so confirm the current edition and follow your own approved procedures.
The volume that can actually be withdrawn from a container, compared with the labelled volume.
When Stage 1 gives a borderline result that the standard allows to be retested. Then 20 more containers are tested and all 30 are evaluated together.
It applies to liquids labelled 250 mL or less within the scope of the chapter. Check the chapter for exemptions.
No. Individual containers must also meet the limits.
Related tools and guides: Deliverable Volume Testing Guide · Unit Converter · Batch Size Calculator
By Sajjad Ahmad. For reference and education only; verify limits against your SOPs and the current pharmacopoeia. See the methodology.