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Merck
CN

1458009

USP

硫酸新霉素

United States Pharmacopeia (USP) Reference Standard

别名:

新霉素 三硫酸盐

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关于此项目

经验公式（希尔记法）:
C23H46N6O13 · 3H2SO4
CAS Number:
1405-10-3
分子量:
908.88
MDL编号:
MFCD00037007
UNSPSC代码:
41116107
NACRES:
NA.24

主要文件

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等级

pharmaceutical primary standard

API类

neomycin

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

[S](=O)(=O)(O)O.N[C@H]1[C@H](O[C@@H]([C@H]([C@@H]1O)O)CN)O[C@H]2[C@@H]([C@H]([C@@H](C[C@@H]2N)N)O)O[C@@H]3O[C@@H]([C@H]([C@H]3O)OC4O[C@H]([C@H]([C@@H]([C@H]4N)O)O)CN)CO

InChI

1S/C23H46N6O13.H2O4S/c24-2-7-13(32)15(34)10(28)21(37-7)40-18-6(27)1-5(26)12(31)20(18)42-23-17(36)19(9(4-30)39-23)41-22-11(29)16(35)14(33)8(3-25)38-22;1-5(2,3)4/h5-23,30-36H,1-4,24-29H2;(H2,1,2,3,4)/t5-,6+,7-,8+,9-,10-,11-,12+,13-,14-,15-,16-,17-,18-,19-,20-,21-,22?,23+;/m1./s1

InChI key

OIXVKQDWLFHVGR-GQTDVWSESA-N

一般描述

Neomycin sulfate is a complex aminoglycoside antibiotic comprising multiple neomycin components. It is active against Gram-negative bacteria and inhibits protein synthesis by binding to the 30S ribosomal subunit. The USP standard supports microbiological potency assays and chromatographic analysis of bulk and finished products.

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

Neomycin sulfate USP reference standard, intended for use in specified quality tests and assays as specified in the USP compendia. Also, for use with USP monographs such as:
  • Neomycin Sulfate Tablets
  • Neomycin Sulfate Cream
  • Neomycin Sulfate Ointment
  • Neomycin Sulfate Ophthalmic Ointment
  • Neomycin Sulfate Oral Solution
  • Neomycin Sulfate and Hydrocortisone Cream

制备说明

Neomycin sulfate is soluble in H2O at 50 mg/mL, yielding a clear solution.

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

Stock solutions should be filter sterilized and stored at 2-8°C, and are stable at 37°C for 5 days. A 1 mg/mL neomycin solution in .1 M phosphate buffer, pH 8.0 should be used within 14 days when stored at 0-5°C. Solutions should be protected from light or moisture.

象形图

Health hazard
GHS08

警示用语：

Danger

危险声明

H317,H334

危险分类

Resp. Sens. 1 - Skin Sens. 1

储存分类代码

11 - Combustible Solids

WGK

WGK 3

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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Neomycin and Polymyxin B Sulfates, Bacitracin Zinc, and Lidocaine Ointment
USP43-NF38 ? 3120: United States Pharmacopeia and National Formulary
United States Pharmacopeia, 28(4) (2013)
Neomycin Sulfate and Hydrocortisone Otic Suspension
USP43-NF38 - 3109: United States Pharmacopeia and National Formulary
United States Pharmacopeia, 49(5) (2013)
Neomycin and Polymyxin B Sulfates and Hydrocortisone Otic Suspension
USP43-NF38 - 3124: United States Pharmacopeia and National Formulary
United States Pharmacopeia (2013)
Neomycin and Polymyxin B Sulfates and Lidocaine Cream
USP43-NF38 - 3126: United States Pharmacopeia and National Formulary
United States Pharmacopeia, 47(4) (2013)
Neomycin Sulfate
USPNF 2023 ISSUE 2 - online: United States Pharmacopeia and National Formulary
United States Pharmacopeia, 48(1) (2023)
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