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Merck
CN

1477003

USP

制霉菌素即用型溶液

United States Pharmacopeia (USP) Reference Standard

别名:

制霉素, 制霉菌素

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关于此项目

CAS Number:
1400-61-9
MDL编号:
MFCD25541651
UNSPSC代码:
41116107
PubChem化学物质编号:
329750594
NACRES:
NA.24

主要文件

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等级

pharmaceutical primary standard

API类

nystatin

表单

solid

制造商/商品名称

USP

应用

USP Biologics
pharmaceutical (small molecule)

包装形式

neat

SMILES字符串

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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一般描述

Nystatin is a polyene antifungal antibiotic produced by Streptomyces noursei. It binds to ergosterol in fungal cell membranes, causing pore formation and leakage of intracellular contents. The USP reference standard is used in microbiological assays to determine potency and confirm identity in nystatin formulations.

The USP biologics antibiotics category includes a wide range of antimicrobial agents that are essential in treating bacterial infections. These antibiotics are derived from various natural sources or synthesized to combat specific pathogens effectively. The USP provides comprehensive standards, reference materials, and analytical procedures to ensure the identity, quality, purity, and consistency of antibiotic therapeutics throughout their lifecycle.

The United States Pharmacopeia (USP) provides quality standards for biologics to ensure their safety, efficacy, and quality throughout the manufacturing process. These standards assist manufacturers in adhering to regulatory requirements and help safeguard public health by reducing risks associated with biologics.

应用

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

生化/生理作用

作用机制：制霉菌素通过与真菌细胞膜中的麦角甾醇结合，增加膜的渗透性和产生基于制霉菌素/麦角甾醇的离子通道起作用。 它还可作为脂筏抑制剂和膜相关胆固醇。

抗菌谱：制霉菌素可对抗真菌、酵母和霉菌。

分析说明

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.  ​

其他说明

This product is part of the USP Biologics program.

法律信息

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.

免责声明

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. ?

储存分类代码

11 - Combustible Solids

WGK

WGK 2

闪点(°F)

Not applicable

闪点(°C)

Not applicable

法规信息

监管及禁止进口产品

历史批次信息供参考:

分析证书(COA)

Lot/Batch Number

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Nystatin
USP43-NF38: United States Pharmacopeia and National Formulary
United States Pharmacopeia, 47(1) (2022)
Nystatin Oral Suspension
USP43-NF38: United States Pharmacopeia and National Formulary
United States Pharmacopeia, 34(1), 3221-3221 (2013)
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 prophylaxis for fungal peritonitis: to be or not to be?
Wai-Choong Lye
Peritoneal dialysis international : journal of the International Society for Peritoneal Dialysis, 27(5), 511-513 (2007-08-21)
M E Alvarez Alvarez et al.
Revista espanola de quimioterapia : publicacion oficial de la Sociedad Espanola de Quimioterapia, 11(4), 295-315 (1999-02-17)
The incidence of oropharyngeal candidiasis is growing. The species of the genus Candida are extremely frequent among human colonizers. The changes in the yeast-human interaction by aging, debilitating, and immunosuppressive diseases, and the more aggressive medical interventions can explain this
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