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1477003

USP

Nystatin

United States Pharmacopeia (USP) Reference Standard

Synonym(s):

Fungicidin, Mycostatin

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About This Item

CAS Number:
MDL number:
UNSPSC Code:
41116107
PubChem Substance ID:
NACRES:
NA.24

grade

pharmaceutical primary standard

API family

nystatin

manufacturer/tradename

USP

application(s)

pharmaceutical (small molecule)

format

neat

SMILES string

O[C@@H]([C@H](C)[C@H](C)O1)[C@@H](C)/C=C/C=C/CC/C=C/C=C/C=C/C=C/[C@H](O[C@@H]2O[C@H](C)[C@@H](O)[C@H](N)[C@@H]2O)C[C@@]3([H])[C@H](C(O)=O)[C@@H](O)C[C@](O)(O3)C[C@@H](O)[C@H](O)CC[C@@H](O)C[C@@H](O)C[C@@H](O)CC1=O

InChI

1S/C47H75NO17/c1-27-17-15-13-11-9-7-5-6-8-10-12-14-16-18-34(64-46-44(58)41(48)43(57)30(4)63-46)24-38-40(45(59)60)37(54)26-47(61,65-38)25-36(53)35(52)20-19-31(49)21-32(50)22-33(51)23-39(55)62-29(3)28(2)42(27)56/h5-6,8,10-18,27-38,40-44,46,49-54,56-58,61H,7,9,19-26,48H2,1-4H3,(H,59,60)/b6-5+,10-8+,13-11+,14-12+,17-15+,18-16+/t27-,28+,29-,30+,31+,32+,33+,34-,35+,36+,37-,38-,40+,41-,42+,43+,44-,46-,47+/m0/s1

InChI key

VQOXZBDYSJBXMA-QEKUPDCNSA-N

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Application

Nystatin USP reference standard suitable for use in specified USP compendial quality tests and assays.

Also used to prepare standard, and system suitability solution for the assay, composition analysis and content uniformity by using liquid chromatography in conjunction with UV detector according to the given below monographs of United States Pharmacopeia (USP): 
  • Nystatin, Neomycin Sulfate, Thiostrepton, and Triamcinolone Acetonide Ointment
  • Nystatin Oral Suspension
  • Nystatin

Biochem/physiol Actions

Mode of Action: Nystatin acts by binding to ergosterols in fungal cell membranes, increasing permeability of the membrane, and creating nystatin/ergosterol based ion channels. It also functions as a lipid raft-inhibiting reagent and as membrane associated cholesterol.

Antimicrobial spectrum: Nystatin acts against fungi, yeasts and molds.

Caution

Nystatin in tissue culuture media is stable at 37°C for three days. It is also stable in moderately alkaline media. Solutions and aqueous suspensions begin to lose activity soon after preparation, with heat, light, and oxygen accelerating the decomposition. Aqueous suspensions are stable for 10 minutes when heating to 100°C at pH 7.
Nystatin is soluble at 28°C in methanol (11.2 mg/mL), ethanol (1.2 mg/mL), carbon tetrachloride (1.23 mg/mL), chloroform (0.48 mg/mL), benzene (0.28 mg/mL), and ethylene glycol (8.75 mg/mL). It is also soluble in DMSO at 5 mg/mL and freely soluble in DMF and formamide. It is not recommended to autoclave or sterile filter solutions of Nystatin. Nystatin is also effective as a suspension, stable at 37°C for 3 days. Prepare 50 mg/mL stock suspensions in water and store at -20°C. ?

Analysis Note

These products are for test and assay use only. They are not meant for administration to humans or animals and cannot be used to diagnose, treat, or cure diseases of any kind.  ​

Other Notes

This product is part of the USP Biologics program.

Legal Information

This product is provided as delivered and specified by the issuing Pharmacopoeia. All information provided in support of this product, including SDS and any product information leaflets have been developed and issued under the Authority of the issuing Pharmacopoeia.For further information and support please go to the website of the issuing Pharmacopoeia.

related product

Product No.
Description
Pricing

Storage Class Code

11 - Combustible Solids

WGK

WGK 2

Flash Point(F)

Not applicable

Flash Point(C)

Not applicable


Certificates of Analysis (COA)

Search for Certificates of Analysis (COA) by entering the products Lot/Batch Number. Lot and Batch Numbers can be found on a product’s label following the words ‘Lot’ or ‘Batch’.

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Nystatin, Neomycin Sulfate, Thiostrepton, and Triamcinolone Acetonide Ointment
USP43-NF38: United States Pharmacopeia and National Formulary
United States Pharmacopeia, 49(4), 3223-3223 (2013)
Nystatin Oral Suspension
USP43-NF38: United States Pharmacopeia and National Formulary
United States Pharmacopeia, 34(1), 3221-3221 (2013)
Nystatin
USP43-NF38: United States Pharmacopeia and National Formulary
United States Pharmacopeia, 47(1) (2022)
P C Gøtzsche et al.
The Cochrane database of systematic reviews, (4)(4), CD002033-CD002033 (2003-01-10)
Nystatin is sometimes used prophylactically in patients with severe immunodeficiency or in the treatment of fungal infection in such patients, although the effect seems to be equivocal. To study whether nystatin decreases morbidity and mortality when given prophylactically or therapeutically
M Schäfer-Korting et al.
Mycoses, 39(9-10), 329-339 (1996-09-01)
Systemic candidosis is currently a major concern among certain groups of patients at particular risk because of recent treatment modalities. To prevent spread of Candida albicans, in particular, from the orogastrointestinal tract antimycotic treatment would appear beneficial. So far, however

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