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Nystatin Oral Suspension
» Nystatin Oral Suspension contains not less than 90.0 percent and not more than 130.0 percent of the labeled amount of USP Nystatin Units. It contains suitable dispersants, flavors, preservatives, and suspending agents.
Packaging and storage
Preserve in tight, light-resistant containers.
Change to read:
Uniformity of dosage units
FOR SUSPENSION PACKAGED IN SINGLE-UNIT CONTAINERS:
meets the requirements.
Procedure for content uniformity
[noteUse low-actinic glassware. The correction factor, F, calculated as directed in section (4) of Content Uniformity under Uniformity of Dosage Units
(CL/D)(AU / AS)
in which C is the concentration, in USP Nystatin Units per mL, of the Standard solution; L is the labeled quantity, in USP Nystatin Units, in the container; D is the concentration, in USP Nystatin Units, in the test solution, on the basis of the labeled quantity in the container and the extent of dilution; and AU and AS are the absorbances of the test solution and the Standard solution, respectively.
Deliverable volume
pH
Assay
Proceed as directed for Nystatin under AntibioticsMicrobial Assays
Auxiliary Information
Please check for your question in the FAQs before contacting USP.
Chromatographic Column
USP32NF27 Page 3123
Pharmacopeial Forum: Volume No. 34(1) Page 103
Chromatographic columns text is not derived from, and not part of, USP 32 or NF 27.
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