As of April 11, 2022
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The following chapters all contain methods relevant to the quantitation of the amount of dosage form contained in a package for a liquid or semisolid product.
• <697> Container Content for Injections
• <698> Deliverable Volume
• <755> Minimum Fill
• <905> Uniformity of Dosage Units
If the product is an injectable product, then <697> should apply. If the product is a liquid in a single-dose unit or gel capsule, then <905> should apply. If the product is an oral liquid, then <698> should apply. For all other cases, then <755> should apply.
USP GC <698> Deliverable Volume is intended to assure that the patient receives the intended volume of the packaged contents as indicated on the product label with a variety of dosing and delivery systems for oral liquids. Other than using the testing procedures described in the chapter, you can use alternative methods to satisfy the <698> requirements per USP General Notice 6.30. Alternative and Harmonized Methods and Procedures. The requirements of this chapter can also be met by following the described testing procedures in <755> Minimum Fill to satisfy these testing requirements and account for any product holdup with the approved packaging components. Such studies may be done during development or post-development. Such an approach should be supported by study data to justify the approved fill volume target and then confirmed for each batch produced using the method described in USP GC <755> Minimum Fill.