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Merck
CN

PHR1715

硫酸西索米星

Pharmaceutical Secondary Standard; Certified Reference Material

别名:

紫苏雷素 硫酸盐

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关于此项目

经验公式(希尔记法):
C19H37N5O7 · 2.5H2O4S
化学文摘社编号:
分子量:
692.72
NACRES:
NA.24
UNSPSC Code:
41116107
EC Number:
258-414-4
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产品名称

硫酸西索米星, Pharmaceutical Secondary Standard; Certified Reference Material

InChI key

CIKNYWFPGZCHDL-ZHFUJENKSA-N

InChI

1S/2C19H37N5O7.5H2O4S/c2*1-19(27)7-28-18(13(26)16(19)24-2)31-15-11(23)5-10(22)14(12(15)25)30-17-9(21)4-3-8(6-20)29-17;5*1-5(2,3)4/h2*3,9-18,24-27H,4-7,20-23H2,1-2H3;5*(H2,1,2,3,4)/t2*9-,10+,11-,12+,13-,14-,15+,16-,17-,18-,19+;;;;;/m11...../s1

SMILES string

OS(O)(=O)=O.OS(O)(=O)=O.OS(O)(=O)=O.OS(O)(=O)=O.OS(O)(=O)=O.CN[C@@H]1[C@@H](O)[C@H](OC[C@]1(C)O)O[C@H]2[C@H](N)C[C@H](N)[C@@H](O[C@H]3OC(CN)=CC[C@H]3N)[C@@H]2O.CN[C@@H]4[C@@H](O)[C@H](OC[C@]4(C)O)O[C@H]5[C@H](N)C[C@H](N)[C@@H](O[C@H]6OC(CN)=CC[C@H]6N)[C@@H]5O

grade

certified reference material
pharmaceutical secondary standard

agency

traceable to Ph. Eur. S0660000
traceable to USP 1612801

API family

sisomicin

CofA

current certificate can be downloaded

packaging

pkg of 1 g

technique(s)

HPLC: suitable
gas chromatography (GC): suitable

application(s)

pharmaceutical (small molecule)

format

neat

storage temp.

-10 to -25°C

Quality Level

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Analysis Note

These secondary standards offer multi-traceability to the USP and EP primary standards, where they are available.

Application

Sisomicin Sulfate may be used as a pharmaceutical reference standard for the quantification of the analyte in pharmaceutical formulations using chromatography techniques.
These Secondary Standards are qualified as Certified Reference Materials. These are suitable for use in several analytical applications including but not limited to pharma release testing, pharma method development for qualitative and quantitative analyses, food and beverage quality control testing, and other calibration requirements.

General description

Sisomicin Sulfate is the sulfate salt of sisomicin, an aminoglycoside antibiotic isolated from Micromonopora inyoensis. It is highly effective against most strains of Klebsiella spp., Escherichia coliP. aeruginosaEnterobacter and Proteus spp. It is a potential treatment for conjunctiva.

Other Notes

This Certified Reference Material (CRM) is produced and certified in accordance with ISO 17034 and ISO/IEC 17025. All information regarding the use of this CRM can be found on the certificate of analysis.
To see an example of a Certificate of Analysis for this material enter LRAC3939 in the Documents slot below. This is an example certificate only and may not be the lot that you receive.

pictograms

Health hazardExclamation mark

signalword

Danger

Hazard Classifications

Acute Tox. 4 Dermal - Acute Tox. 4 Inhalation - Repr. 1B

存储类别

6.1C - Combustible acute toxic Cat.3 / toxic compounds or compounds which causing chronic effects

wgk

WGK 3

flash_point_f

Not applicable

flash_point_c

Not applicable

法规信息

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Determination of gentamicin sulphate composition and related substances in pharmaceutical preparations by LC with charged aerosol detection
Stypulkowska K, et al.
Chromatographia, 72(11-12), 1225-1229 (2010)
Arul Joseph et al.
Journal of pharmaceutical and biomedical analysis, 51(3), 521-531 (2009-10-10)
Gentamicin sulfate is a potent broad spectrum aminoglycoside antibiotic which is used as an active pharmaceutical ingredient (API) against both Gram-positive and Gram-negative bacteria. A reversed-phase high performance liquid chromatographic (RP-HPLC) method has been developed and validated to determine the

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