Gentamicin Sulfate EP Impurity E CAS 2037-48-1
| CAS No. | 2037-48-1 |
| Molecular Formula | C6H14N2O3 |
| Molecular Weight | 162.19 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
Under current pharmacopoeial and regulatory frameworks, quality-control requirements for this class of reference material explicitly involve the control of targets including Gentamicin Sulfate EP Impurity E.
As a process- or degradation-related impurity, Gentamicin Sulfate EP Impurity E (CAS 2037-48-1, C6H14N2O3) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
Owing to an amino-acid-derived structure, an amide group, a hydroxyl group, an ether linkage, Gentamicin Sulfate EP Impurity E is typically white to off-white crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 162.19 g/mol — guide the selection of appropriate sample preparation and analytical techniques. 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 | C6H14N2O3 |
| Molecular Weight | 162.19 g/mol |
| Purity | >80% |
| 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.) | 1957 |
| Nitrogen Atoms | 2 |
Related Gentamicin Standards
- Gentamicin Impurity 13 (CAS 49751-51-1)
- Gentamicin B Sulfate (CAS 43169-50-2)
- Gentamicin Sulfate C1 (CAS 38539-12-7)
- Gentamicin (CAS 1403-66-3)
- Gentamicin Impurity 11 Pentaacetate Salt (CAS 25876-10-2(free base))
- Gentamicin B1 • xAcetate Salt (CAS 36889-16-4（free base）)
- Gentamicin C2b Pentatrifluoroacetate (CAS 52093-21-7 (free base))
- Gentamicin C1 Pentaacetate Salt (CAS CATO-C4X-148019)
Recommended Standards
- Indapamide EP Impurity A (Mixture of Diastereomers) (CAS 85440-79-5)
- Butylphthalide Impurity 30 (CAS 17475-41-1)
- Indapamide Impurity 43 (CAS CATO-C4X-140043)
- Selegiline Impurity 7 (CAS CATO-C4X-19167)
- Gadoteridol Impurity 21 (CAS CATO-C4X-225721)
- Acyclovir EP Impurity P (CAS 23169-33-7)
- Omeprazole Impurity 50 (CAS CATO-C4X-125550)
- Methyl 2-(benzo[d][1,3]dioxol-5-yl)-2-hydroxyacetate (CAS 86259-32-7)
- 5,5-Dimethyl-1,4,5,6-tetrahydrocyclopenta[b]pyrrole-2-carboxylic acid (CAS 1936533-04-8)
- 51996-41-9 Methyl 2,3,6-Trideoxy-3-[(2,2,2-trifluoroacetyl)amino]-L-lyxo-hexopyranoside Methyl N-Trifluoroacetyldaunosaminide (CAS 51996-41-9)
- 2,2,2-trifluoro-1-(3-{1H-imidazo[4,5-b]pyridin-2-yl}azetidin-1-yl)ethan-1-one (CAS 2626047-51-4)
- Prochlorperazine RC 5 (CAS 367274-46-2)
- 6-Bromo-3H-spiro[isobenzofuran-1,4'-piperidin]-3-one (CAS 1780517-32-9)
- Tau Peptide (244-274) (Repeat 1 Domain) trifluoroacetate salt (CAS 330456-24-1)
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