PRODUCT QUALITY TESTS COMMON TO PARENTERAL DOSAGE FORMS
Universal Tests
Universal tests are listed below and are applicable to parenteral dosage forms.
identification
Identification tests are discussed in General Notices, 5.40 Identification should establish the identity of the drug or drugs present in the article and should discriminate between compounds of closely related structure that are likely to be present..
assay
A specific and stability-indicating test should be used to determine the strength (content) of the drug product. In cases where the use of a nonspecific assay is justified, other supporting analytical procedures should be used to achieve overall specificity. A specific procedure should be used when there is evidence of excipient interference with the nonspecific assay.
impurities
Tests for Impurities are discussed in ▲General Notices, 5.60 Impurities and Contaminants in Official Articles▲ (CN 1-Aug-2025). All articles should be tested to ensure that they meet the requirements.
foreign and particulate matter
Articles intended for parenteral administration should be prepared in a manner designed to exclude particulate matter as defined in Subvisible Particulate Matter in Therapeutic Protein Injections 〈787〉, Particulate Matter in Injections 〈788〉, or Subvisible Particulate Matter in Intraocular Solutions 〈789〉, as well as excluding other foreign matter as appropriate for the dosage form. Each final container of all parenteral preparations should be inspected to the extent possible for the presence of observable foreign and particulate matter (hereafter termed visible particulates) in its contents. The inspection process should be designed and qualified to ensure that every lot of all parenteral preparations is essentially free from visible particulates, as defined in Visible Particulates in Injections 〈790〉. Qualification of the inspection process should be performed with reference to particulates in the visible range and those particulates that might emanate from the manufacturing or filling process. Every container in which the contents show evidence of visible particulates must be rejected. The inspection for visible particulates may take place during examination for other defects such as cracked or defective containers or seals, or when characterizing the appearance of a lyophilized product.
When the nature of the contents or the container–closure system permits only limited inspection of the total contents, the 100% inspection of a lot should be supplemented with the inspection of constituted (e.g., dried) or withdrawn (e.g., from a dark amber container) contents of a sample of containers from the lot.
Large-volume injections for single-dose infusion, small-volume injections, and pharmacy bulk packages (PBPs) are subject to the light obscuration or microscopic procedures and limits for subvisible particulate matter set forth in 〈788〉, unless otherwise specified in the chapter or in the individual monograph. An article packaged as both a large-volume and a small-volume injection meets the requirements set forth for small-volume injections where the container is labeled as containing 100 mL or less. It meets the requirements set forth for large-volume injections for single-dose infusion where the container is labeled as containing more than 100 mL.
Source from USP and Please refer to USP for details:
https://online.uspnf.com/uspnf/document/1_GUID-AFAE78DE-CFF4-46D3-9FAA-9507553FC215_5_en-US?
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