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PHR1487

Kanamycin Sulfate

Pharmaceutical Secondary Standard; Certified Reference Material

Synonym(s):

Kanamycin sulfate from Streptomyces kanamyceticus, Kanamycin A, Kanamycin sulfate salt

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About This Item

Empirical Formula (Hill Notation):
C18H36N4O11 · H2O4S
CAS Number:
25389-94-0
Molecular Weight:
582.58
NACRES:
NA.24
PubChem Substance ID:
329823411
UNSPSC Code:
41116107
EC Number:
246-933-9
MDL number:
MFCD00070253

Key Documents

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Product Name

Kanamycin Sulfate, Pharmaceutical Secondary Standard; Certified Reference Material

InChI key

OOYGSFOGFJDDHP-KMCOLRRFSA-N

InChI

1S/C18H36N4O11.H2O4S/c19-2-6-10(25)12(27)13(28)18(30-6)33-16-5(21)1-4(20)15(14(16)29)32-17-11(26)8(22)9(24)7(3-23)31-17;1-5(2,3)4/h4-18,23-29H,1-3,19-22H2;(H2,1,2,3,4)/t4-,5+,6-,7-,8+,9-,10-,11-,12+,13-,14-,15+,16-,17-,18-;/m1./s1

SMILES string

OS(O)(=O)=O.NC[C@H]1O[C@H](O[C@@H]2[C@@H](N)C[C@@H](N)[C@H](O[C@H]3O[C@H](CO)[C@@H](O)[C@H](N)[C@H]3O)[C@H]2O)[C@H](O)[C@@H](O)[C@@H]1O

grade

certified reference material
pharmaceutical secondary standard

agency

traceable to Ph. Eur. K0200000
traceable to USP 1355006

API family

kanamycin

CofA

current certificate can be downloaded

packaging

pkg of 500 mg

technique(s)

HPLC: suitable
gas chromatography (GC): suitable

application(s)

pharmaceutical (small molecule)

format

neat

storage temp.

2-8°C

Quality Level

300

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Analysis Note

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

Application

Kanamycin Sulfate may be used as a pharmaceutical reference standard for the determination of the analyte in pharmaceutical formulations by various 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.

Biochem/physiol Actions

Mode of Action: The product acts by binding to the 70S ribosomal subunit, inhibiting translocation and eliciting miscoding.

Mode of Resistance:Aminoglycoside-modifying enzymes (including acetyltransferase, phosphotransferase, nucleotidyltransferase) can alter this antibiotic, preventing its interaction with ribosomes.

Antimicrobial spectrum: Kanamycin sulfate is effective against gram-negative and gram-postiive bacteria, and mycoplasma.

General description

Pharmaceutical secondary standards for application in quality control provide pharma laboratories and manufacturers with a convenient and cost-effective alternative to the preparation of in-house working standards.
Kanamycin Sulfate, generated by specific strains of Streptomyces kanamyceticus, belongs to the class of aminoglycoside antibiotics. It is known to act effectively against a broad spectrum of Gram-negative and Gram-positive bacteria.

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 LRAB7808 in the slot below. This is an example certificate only and may not be the lot that you receive.

pictograms

Health hazard
GHS08

signalword

Danger

hcodes

H360D

Hazard Classifications

Repr. 1B

Storage Class

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

wgk

WGK 2

flash_point_f

Not applicable

flash_point_c

Not applicable

Regulatory Information

涉药品监管产品
This item has

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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Development and validation of a novel LC non-derivatization method for the determination of amikacin in pharmaceuticals based on evaporative light scattering detection
Galanakis EG, et al.
Journal of Pharmaceutical and Biomedical Analysis, 40(5), 1114-1120 (2006)
Development and validation of a novel LC/ELSD method for the quantitation of gentamicin sulfate components in pharmaceuticals
Megoulas NC and Koupparis MA
Journal of Pharmaceutical and Biomedical Analysis, 36(1), 73-79 (2004)
Quantitative determination and separation of analogues of aminoglycoside antiobiotcs by high-performance liquid chromatography
Gambardella P, et al.
Journal of Chromatography A, 348(12), 229-240 (1985)
Determination of aminoglycosides in pharmaceutical formulations-II. High-performance liquid chromatography
Fabre H, et al.
Journal of Pharmaceutical and Biomedical Analysis, 7(12), 1711-1718 (1989)

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