(nye stat' in).
» Nystatin is a substance, or a mixture of two or more substances, produced by the growth of Streptomyces noursei Brown et al. (Fam. Streptomycetaceae). It has a potency of not less than 4400 USP Nystatin Units per mg, or, where intended for use in the extemporaneous preparation of oral suspensions, not less than 5000 USP Nystatin Units per mg.
Packaging and storage Preserve in tight, light-resistant containers.
Labeling Where packaged for use in the extemporaneous preparation of oral suspensions, the label so states.
USP Reference standards 11
Identification, Ultraviolet Absorption 197U
Solution: 10 µg per mL, prepared as follows. Transfer about 50 mg to a glass-stoppered, 100-mL volumetric flask, add 25 mL of methanol and 5 mL of glacial acetic acid to dissolve the specimen, dilute with methanol to volume, and mix. Pipet 2 mL of this solution into a 100-mL volumetric flask, dilute with methanol to volume, and mix.
Ratio: the ratio (A230/A279(sh)) is between 0.90 and 1.25.
Solution A Prepare a mixture of 0.05 M ammonium acetate and acetonitrile (71:29).
Solution B Prepare a mixture of acetonitrile and 0.05 M ammonium acetate (60:40).
Mobile phase Use variable mixtures of Solution A and Solution B as directed for Chromatographic system. Make adjustments if necessary (see System Suitability under Chromatography 621).
Standard solution Quantitatively dissolve an accurately weighed quantity of USP Nystatin RS in dimethyl sulfoxide to obtain a solution having a known concentration of about 0.4 mg per mL. [noteProtect this solution from light and use within 24 hours, if stored in the refrigerator. ]
Test solution Transfer about 20 mg of Nystatin, accurately weighed, to a low-actinic 50-mL volumetric flask, dissolve in and dilute with dimethyl sulfoxide to volume, and mix. [noteUse this solution within 24 hours, if stored in the refrigerator. ]
System suitability solution Dissolve about 20 mg of Nystatin in 25 mL of methanol, dilute with water to 50 mL, and mix. To 10.0 mL of this solution add 2.0 mL of diluted hydrochloric acid, and allow to stand at room temperature for 1 hour.
Chromatographic system (see Chromatography 621) The liquid chromatograph is equipped with a 304-nm detector and a 4.6-mm × 15-cm column that contains base-deactivated end-capped 5-µm packing L1. The column is maintained at a constant temperature of about 30. The flow rate is about 1 mL per minute. The chromatograph is programmed as follows.
Procedure Inject about 20 µL of the Test solution into the chromatograph, record the chromatogram, and measure the peak area responses for all of the peaks, disregarding any peaks eluting in less than 2 minutes. Calculate the percentage of each peak by the formula:
100ri / rTin which ri is the response of an individual peak; and rT is the total of all of the responses, any peaks eluting in less than 2 minutes being disregarded. Not less than 85.0% of nystatin A1 is found; and not more than 4.0% of any other individual component is found.
Suspendibility (where packaged for use in the extemporaneous preparation of oral suspensions) Transfer about 200 mg, accurately weighed, to a 250-mL beaker containing 200.0 mL of water, and disperse by stirring gently with a stirring rod. Allow to stand for 2 minutes, and observe the suspension: the material is in suspension, and little or no sediment is present on the bottom of the beaker. If there is any sediment, assay the undisturbed suspension as directed for nystatin under AntibioticsMicrobial Assays 81, using an accurately measured volume of it blended in a high-speed blender for 3 to 5 minutes with a sufficient accurately measured volume of dimethylformamide to give a concentration of about 400 USP Nystatin Units per mL. Dilute this stock solution quantitatively with Buffer No. 6 to obtain a Test Dilution having a concentration assumed to be equal to the median dose level of the Standard: not less than 90.0% of the expected number of USP Nystatin Units is found, based on the potency obtained in the Assay.
Crystallinity (where packaged for use in the extemporaneous preparation of oral suspensions) 695: meets the requirements.
pH 791: between 6.0 and 8.0, in a 3% aqueous suspension.
Loss on drying 731 Dry about 100 mg, accurately weighed, in a capillary-stoppered bottle in vacuum at a pressure not exceeding 5 mm of mercury at 60 for 3 hours: it loses not more than 5.0% of its weight.
Assay Proceed with Nystatin as directed under AntibioticsMicrobial Assays 81.
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USP35NF30 Page 4090Pharmacopeial Forum: Volume No. 30(1) Page 141