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PHR1715

Supelco

Sisomicin Sulfate

Pharmaceutical Secondary Standard; Certified Reference Material

Synonym(s):
Sisomicin sulfate salt
Empirical Formula (Hill Notation):
C19H37N5O7 · 2.5H2O4S
CAS Number:
Molecular Weight:
692.72
EC Number:
NACRES:
NA.24

Quality Level

grade

certified reference material
pharmaceutical secondary standard

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

pharmacopeia traceability

traceable to PhEur S0660000
traceable to USP 1612801

storage temp.

-10 to -25°C

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

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

InChI key

CIKNYWFPGZCHDL-ZHFUJENKSA-N

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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.

Application

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.
Sisomicin Sulfate may be used as a pharmaceutical reference standard for the quantification of the analyte in pharmaceutical formulations using chromatography techniques.

Analysis Note

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

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.

Footnote

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

Exclamation markHealth hazard

Signal Word

Danger

Hazard Statements

Hazard Classifications

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

Storage Class Code

6.1D - Non-combustible, acute toxic Cat.3 / toxic hazardous materials or hazardous materials causing chronic effects

WGK

WGK 3

Flash Point(F)

Not applicable

Flash Point(C)

Not applicable

Certificate of Analysis

Certificate of Origin

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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