Category
Amikacin
CAS Number
Amikacin STD-37517-28-5;39831-55-5(Amikacin sulphate - API (Disulphate Salt)): IMP-A-50725-24-1;NA(Sulphate Salt): IMP-B-927821-99-6: IMP-F-197909-67-4;NA(Sulphate Salt): IMP-H-48237-20-3;NA(Sulphate Salt)
Molecular Formula
Amikacin STD-C22H43N5O13: IMP-A-C22H43N5O13: IMP-B-C26H50N6O15: IMP-F-C26H50N6O15: IMP-H-C22H44N6O12
Molecular Weight
Amikacin STD-585.60: IMP-A-585.6: IMP-B-686.71: IMP-F-686.71: IMP-H-584.62
Synonym

Amikacin STD-(2S)-4-amino-N-[(1R,2S,3S,4R,5S)-5-amino-2-[(2S,3R,4S,5S,6R)-4-amino-3,5-dihydroxy-6-(hydroxymethyl)oxan-2-yl]oxy-4-[(2R,3R,4S,5S,6R)-6-(aminomethyl)-3,4,5-trihydroxyoxan-2-yl]oxy-3-hydroxycyclohexyl]-2-hydroxybutanamide; Amikacin - API (IP); 6-O-(3-Amino-3-deoxy-α-D-glucopyranosyl)-4-O-(6-amino-6-deoxy-α-D- glucopyranosyl)-1-N-[(2S)-4-amino-2-hydroxybutanoyl]-2-deoxy-D-streptamine; Amikacillin; Amikozit; Amukin; Antibiotic BB-K 8; Arikace; Lukadin; Potentox;(S)-O-3-Amino-3-deoxy-α-D-glucopyranosyl-(1→6)-O-[6-amino-6-deoxy-α-D-glucopyranosyl-(1→4)]-N1-(4-amino-2-hydroxy-1-oxobutyl)-2-deoxy-D-streptamine; 1-N-[L-(-)-γ-Amino-α-hydroxybutyryl]kanamycin A; Amicacin; BAY 41-6551; BAY 416651; BB-K 8; (S)-4-amino-N-((1R,2S,3S,4R,5S)-5-amino-2-(((2S,3R,4S,5S,6R)-4-amino-3,5-dihydroxy-6-(hydroxymethyl)tetrahydro-2H-pyran-2-yl)oxy)-4-(((2R,3R,4S,5S,6R)-6-(aminomethyl)-3,4,5-trihydroxytetrahydro-2H-pyran-2-yl)oxy)-3-hydroxycyclohexyl)-2-hydroxybutanamide (USP)

Amikacin EP-Impurity-A-(2S)-4-amino-N-[(1S,2R,3R,4S,5R)-5-amino-4-[(2S,3R,4S,5S,6R)-4-amino-3,5-dihydroxy-6-(hydroxymethyl)oxan-2-yl]oxy-2-[(2R,3R,4S,5S,6R)-6-(aminomethyl)-3,4,5-trihydroxyoxan-2-yl]oxy-3-hydroxycyclohexyl]-2-hydroxybutanamide; 4-O-(3-Amino-3-deoxy-a-D-glucopyranosyl)-6-O-(6-amino-6-deoxy-a-D-glucopyranosyl)-1-N-[(2S)-4-amino-2-hydroxybutanoyl]-2-deoxy-L-streptamine

Amikacin EP-Impurity-B-(2S)-4-amino-N-[(1R,2S,5S)-2-[(2S,4S,5S)-4-amino-3,5-dihydroxy-6-(hydroxymethyl)oxan-2-yl]oxy-5-[[(2S)-4-amino-2-hydroxybutanoyl]amino]-4-[(2R,5S)-6-(aminomethyl)-3,4,5-trihydroxyoxan-2-yl]oxy-3-hydroxycyclohexyl]-2-hydroxybutanamide; 4-O-(3-Amino-3-deoxy-a-D-glucopyranosyl)-6-O-(6-amino-6-deoxy-a-D-glucopyranosyl)-1,3-N-bis[(2S)-4-amino-2-hydroxybutanoyl]-2-deoxy-L-streptamine

Amikacin EP-Impurity-F-(2S)-4-amino-N-[[(3S,6R)-6-[(3S,4R,6S)-6-amino-3-[(2S,4S,5S)-4-amino-3,5-dihydroxy-6-(hydroxymethyl)oxan-2-yl]oxy-4-[[(2S)-4-amino-2-hydroxybutanoyl]amino]-2-hydroxycyclohexyl]oxy-3,4,5-trihydroxyoxan-2-yl]methyl]-2-hydroxybutanamide; 6-O-(3-Amino-3-deoxy-α-D-glucopyranosyl)-4-O-[6-[(2S)-4-amino-2-hydroxybutanoyl]amino-6-deoxy-α-D-glucopyranosyl]-1-N-[(2S)-4-amino-2-hydroxybutanoyl]-2-deoxy-D-streptamine

Amikacin EP-Impurity-H-(2S)-4-amino-N-[(1R,4R,5R)-5-amino-4-[(2R,4R,5S)-3-amino-6-(aminomethyl)-4,5-dihydroxyoxan-2-yl]oxy-2-[(2S,4S,5S)-4-amino-3,5-dihydroxy-6-(hydroxymethyl)oxan-2-yl]oxy-3-hydroxycyclohexyl]-2-hydroxybutanamide; 6-O-(3-Amino-3-deoxy-α-D-glucopyranosyl)-1-N-[(2S)-4-amino-2-hydroxybutanoyl]-4-O-(2,6-diamino-2,6-dideoxy-α-D-glucopyranosyl)-2-deoxy-D-streptamine

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Purity:

Above - 95.0%

Technical Data:

We will provide complete documentation support for every Standard Material. All analytical reports such as ¹H NMR, ¹³C NMR, Mass, FT-IR, HPLC Purity/GC Purity/QNMR Purity, Water content by KF/ Loss on Drying/TGA (Thermo-gravimetric Analysis). Certificate of Analysis with potency report. Each Standard Material SER (Structure Elucidation Report) with NMR, Mass, IR spectral interpretation. This whole analytical document can be included in eCTD, ANDA, DMF submissions to regulatory agencies.

Amikacin for System Suitability CRS refers to using a certified reference standard of amikacin to verify that an analytical system (like HPLC, LC-MS, or UV spectrophotometry) is performing correctly before analyzing test samples. It ensures the system’s precision, accuracy, resolution, and reproducibility, confirming that results obtained for amikacin in formulations are reliable and compliant with pharmacopeial requirements.