Product Information

Amikacin Impurity 1

Amikacin Impurity 1
Catalogue number AMK-015
Product Name Amikacin Impurity 1
Sub Category Pharma Reference Standard; Pharmaceutical/API Drug Impurities/Metabolites
API Amikacin
CAS Number 50866-72-3
HS Code 29339900
Molecular formula C22H43N5O13
Molecular Weight 585.6 g/mol
Synonyms Amikacin Sulfate Impurity E (As per 35.1 EP Monograph); 6-O-(6-amino-6-deoxy-a-D-glucopyranosyl)-4-O-[5-[[(2S)-4-amino-2-hydroxybutanoyl]amino]-3-deoxy-a-Dglucopyranosyl]-2-deoxy-D-streptamine; (S)-4-Amino-N-(((2R,3S,4S,5R,6R)-6-(((1R,2R,3S,4R,6S)-4,6-diamino-3-(((2S,3R,4S,5S,6R)-4-amino-3,5-dihydroxy-6-(hydroxymethyl)tetrahydro-2H-pyran-2-yl)oxy)-2-hydroxycyclohexyl)oxy)-3,4,5-trihydroxytetrahydro-2H-pyran-2-yl)methyl)-2-hydroxybutanamide
Chemical Name (S)-4-amino-N-(((2R,3S,4S,5R,6R)-6-(((1R,2R,3S,4R,6S)-4,6-diamino-3-(((2S,3R,4S,5S,6R)-4-amino-3,5-dihydroxy-6-(hydroxymethyl)tetrahydro-2H-pyran-2-yl
Appearance white or off-white, crystalline powder
Storage 2-8°C Refrigerator
Applications The product can be used as reference standard.
Information Amikacin Impurity 1 is supplied with detailed characterization data compliant with regulatory guideline. Amikacin Impurity 1 can be used for the analytical method development, method validation (AMV), Quality Controlled (QC) application for Abbreviated New Drug Application (ANDA) or during commercial production of Amikacin.
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Chemical Name: Amikacin Impurity 1

Synonym: Amikacin Sulfate Impurity E (As per 35.1 EP Monograph); 6-O-(6-amino-6-deoxy-a-D-glucopyranosyl)-4-O-[5-[[(2S)-4-amino-2-hydroxybutanoyl]amino]-3-deoxy-a-Dglucopyranosyl]-2-deoxy-D-streptamine; (S)-4-Amino-N-(((2R,3S,4S,5R,6R)-6-(((1R,2R,3S,4R,6S)-4,6-diamino-3-(((2S,3R,4S,5S,6R)-4-amino-3,5-dihydroxy-6-(hydroxymethyl)tetrahydro-2H-pyran-2-yl)oxy)-2-hydroxycyclohexyl)oxy)-3,4,5-trihydroxytetrahydro-2H-pyran-2-yl)methyl)-2-hydroxybutanamide

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