Amikacin EP Impurity I CAS 40371-51-5
| CAS No. | 40371-51-5 |
| Molecular Formula | C4H9NO3 |
| Molecular Weight | 119.12 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
The occurrence of Amikacin EP Impurity I is closely related to an amino-acid-derived structure, an amide group, a hydroxyl group, an ether linkage in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.
Amikacin EP Impurity I (CAS 40371-51-5) is a certified pharmaceutical impurity reference standard with the molecular formula C4H9NO3 and a molecular weight of 119.12 g/mol.
Based on its molecular formula C4H9NO3, Amikacin EP Impurity I contains an amino-acid-derived structure, an amide group, a hydroxyl group, an ether linkage; these features give the compound characteristic functional-group stretching vibrations in infrared spectroscopy. The molecular weight of 119.12 g/mol is directly relevant to the identification of the molecular ion in mass spectrometry. Nitrogen-containing functional groups confer excellent ionization efficiency in positive-ion electrospray (ESI) mode, making the compound well suited to LC-MS/MS analysis.
This reference standard supports related-substances testing and method development in line with ICH Q3A/Q3B guidance on impurity control, and is suitable for system suitability testing and forced-degradation studies.
The assigned purity is verified by mass-balance and quantitative NMR (qNMR) approaches, with the expanded uncertainty reported at a 95% confidence level (k=2). Batch homogeneity and stability are independently assessed for every lot.
Physical & Chemical Properties
| Molecular Formula | C4H9NO3 |
| Molecular Weight | 119.12 g/mol |
| Purity | >95% |
| Storage | Store at 2-8°C, protect from light, keep sealed and dry |
| Solubility (reference) | Soluble in methanol, ethanol, DMSO, water |
| Stability | Light-sensitive; avoid direct strong light; Hygroscopic; reseal immediately after opening |
| Degree of Unsaturation (DBE) | 1.0 |
| CAS Registry Year (est.) | 1968 |
| Nitrogen Atoms | 1 |
Related Amikacin Standards
- Amikacin impurity 27 (CAS 102419-16-9)
- Amikacin Sulfate (CAS 149022-22-0)
- Amikacin Dihydrate (CAS 37517-28-5（free base）)
- Amikacin B Sulfate (Amikacin EP Impurity H Sulfate) (CAS 48237-20-3(free base))
- Amikacin EP Impurity G ·X HCl (CAS 50896-99-6(Free Base))
- Amikacin Impurity 23 (CAS 84064-35-7)
- Amikacin hydrate (CAS 1257517-67-1)
- Amikacin Sulfate (CAS 39831-55-5)
Recommended Standards
- Benserazide EP Impurity A (CAS 64616-76-8)
- H-D-Homoser-OH (CAS 6027-21-0)
- Avanafil Impurity 73 (CAS 59566-45-9)
- 1H-Benzotriazole (CAS 95-14-7)
- Clofazimine Impurity 16 (CAS CATO-C4X-207116)
- Olmesartan impurity 7 (CAS 144690-33-5)
- Rosuvastatin Impurity 61 (CAS 124752-23-4)
- (E)-Methyl 3-(3-aminophenyl)acrylate (CAS 163487-10-3)
- YK-VP-004 (CAS CATO-C3D-262767)
- (s)-2-(1-Hydroxyethyl)-4-methylphenol (CAS 1344912-98-6)
- 1-((R,2E,4E,6E)-8-hydroxy-6-methyldodeca-2,4,6-trienoyl)pyrrolidin-2-one (CAS 19504-77-9)
- 7-Bromo-4-chloro-2-(chloromethyl)quinazoline (CAS 573681-19-3)
- (3-Aminopiperidin-1-yl)(pyrazin-2-yl)methanone hydrochloride (CAS 1185316-35-1)
- Des-Leu14-Tirzepatide (CAS CATO-CPTD788959)
Why CATO?
- ISO 17034 accredited reference material producer (CNAS + ANAB dual accreditation)
- 130,000+ catalog items in stock, COA supplied with every batch
- Worldwide shipping with full export documentation (HS code guidance available)
- Technical support: +86 18665070610 / Nicole.chen@cato-chem.com