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PHR1715

Supelco

Sisomicin Sulfate

Pharmaceutical Secondary Standard; Certified Reference Material

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Synonym(s):
Sisomicin sulfate salt
Empirical Formula (Hill Notation):
C19H37N5O7 · 2.5H2O4S
CAS Number:
53179-09-2
Molecular Weight:
692.72
EC Number:
258-414-4
UNSPSC Code:
41116107
NACRES:
NA.24

grade

certified reference material
pharmaceutical secondary standard

Quality Level

300

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

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 coli, P. aeruginosa, Enterobacter and Proteus spp. It is a potential treatment for conjunctiva.

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.

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

Health hazardExclamation mark
GHS08,GHS07

Signal Word

Danger

Hazard Statements

H312 + H332,H360

Hazard Classifications

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

WGK

WGK 3

Flash Point(F)

Not applicable

Flash Point(C)

Not applicable

Regulatory Information

监管及禁止进口产品

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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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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