Product Information

Amikacin EP Impurity I

Amikacin EP Impurity I
Catalogue number AMK-007
Product Name Amikacin EP Impurity I
Sub Category Pharma Reference Standard; Pharmaceutical/API Drug Impurities/Metabolites
API Amikacin
CAS Number 40371-51-5
HS Code 29339900
Molecular formula C4H9NO3
Molecular Weight 119.1 g/mol
Synonyms Amikacin Sulfate Impurity I (As per 35.1 EP Monograph); (S)-(-)-4-Amino-2-hydroxybutyric Acid; (S)-4-Amino-2-hydroxybutanoic Acid; (S)-4-Amino-2-hydroxybutyric Acid; 4-Amino-(2S)-hydroxybutyric Acid;L-γ-Amino-α-hydroxybutyric Acid; L-(-)-γ-Amino-α-hydroxybutyric Acid; L-4-Amino-2-hydroxybutyric Acid
Chemical Name (2S)-4-amino-2-hydroxybutanoic acid
Appearance Off-White Solid
Storage 2-8°C Hygroscopic, Refrigerator, under inert atmosphere
Applications The product can be used as reference standard.
Information Amikacin EP Impurity I is supplied with detailed characterization data compliant with regulatory guideline. Amikacin EP Impurity I 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 EP Impurity I

Synonym: Amikacin Sulfate Impurity I (As per 35.1 EP Monograph); (S)-(-)-4-Amino-2-hydroxybutyric Acid; (S)-4-Amino-2-hydroxybutanoic Acid; (S)-4-Amino-2-hydroxybutyric Acid; 4-Amino-(2S)-hydroxybutyric Acid;L-γ-Amino-α-hydroxybutyric Acid; L-(-)-γ-Amino-α-hydroxybutyric Acid; L-4-Amino-2-hydroxybutyric Acid

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