Gentamycin Sulfate EP Impurity C (Gentamicin B1) CAS 36889-16-4
| CAS No. | 36889-16-4 |
| Molecular Formula | C20H40N4O10 |
| Molecular Weight | 496.55 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
Recommended for quantitative analysis by HPLC, GC, LC-MS/MS, or GC-MS as an external calibration standard; it can also be used for spiked-recovery experiments, LOD/LOQ determination, and LC-MS/MS multiple-reaction-monitoring (MRM) calibration.
As a process- or degradation-related impurity, Gentamycin Sulfate EP Impurity C (Gentamicin B1) (CAS 36889-16-4, C20H40N4O10) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
The molecular framework of Gentamycin Sulfate EP Impurity C (Gentamicin B1) (C20H40N4O10) is characterized by an amide group, a carboxylic acid group, a hydroxyl group, an ether linkage. In reversed-phase chromatography, its retention is governed primarily by the protonation state of its nitrogen-containing groups, which provides a practical basis for HPLC-UV/DAD or LC-MS method development. The presence of an aromatic ring or conjugated system gives the compound characteristic absorption bands in the UV-Vis region, making it well suited to UV or diode-array detection (DAD).
As a certified reference material (CRM), Gentamycin Sulfate EP Impurity C (Gentamicin B1) meets the metrological traceability requirements of ISO/IEC 17025 laboratories. Batch-to-batch consistency is monitored via control charts to guarantee comparable assigned values across lots.
Physical & Chemical Properties
| Molecular Formula | C20H40N4O10 |
| Molecular Weight | 496.55 g/mol |
| Appearance | White to pale yellow crystalline powder |
| Purity | >95% |
| Storage | Store in a cool place (≤25°C), protect from light, keep sealed and dry |
| Solubility (reference) | Soluble in DMSO, DMF, methanol |
| Stability | May oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light; Hygroscopic; reseal immediately after opening |
| Degree of Unsaturation (DBE) | 3.0 |
| UV Absorption | UV-absorbing |
| CAS Registry Year (est.) | 1967 |
| Nitrogen Atoms | 4 |
Related Gentamycin Standards
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