Nateglinide EP Impurity B CAS 105816-05-5
| CAS No. | 105816-05-5 |
| Molecular Formula | C19H27NO3 |
| Molecular Weight | 317.42 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
Nateglinide EP Impurity B (CAS 105816-05-5) is a certified pharmaceutical impurity reference standard with the molecular formula C19H27NO3 and a molecular weight of 317.42 g/mol.
Structurally, Nateglinide EP Impurity B (C19H27NO3) contains a steroid core, an amide group, a hydroxyl group, an ether linkage. The molecule exhibits a degree of unsaturation (DBE) of 7.0, corresponding to approximately 7 ring(s) or double-bond equivalent(s). With a molecular weight of 317.42 g/mol, it falls into the moderately-high-molecular-weight range. 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).
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.
As a certified reference material (CRM), Nateglinide EP Impurity B 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 | C19H27NO3 |
| Molecular Weight | 317.42 g/mol |
| Appearance | Off-white to pale yellow crystalline powder |
| Purity | 97%+ |
| Storage | Store at 2-8°C, protect from light, keep sealed and dry |
| Solubility (reference) | Soluble in chloroform, dichloromethane, ethyl acetate, DMSO |
| Stability | May oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light |
| Degree of Unsaturation (DBE) | 7.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 1987 |
| Nitrogen Atoms | 1 |
Related Nateglinide Standards
- Nateglinide Impurity 3 (CAS 491828-09-2)
- Nateglinide (CAS 105816-04-4)
- Nateglinide EP Impurity C (CAS 105816-06-6)
- Nateglinide EP Impurity C (CAS CATO-C4X-13209)
- Nateglinide-d5 (phenyl-d5) (CAS 1227666-13-8)
- Nateglinide Impurity 2 (CAS 105746-38-1)
- Nateglinide EP Impurity E (CAS 105746-45-0)
- Nateglinide Impurity 8 (CAS 105746-47-2)
Recommended Standards
- 32293-42-8 Benzeneethanamine,4-(phenylmethoxy)-N-(phenylmethyl)- CTK4G8465 (CAS 32293-42-8)
- Dutasteride EP Impurity A (CAS 104239-97-6)
- Tetrabenazine Related Compound C (CAS 86457-13-8)
- Dutasteride Impurity 31 (CAS CATO-C4X-110331)
- Formoterol impurity 146 (CAS CATO-C4X-1525146)
- Bortezomib Impurity 20 (CAS 862894-96-0)
- Galanthamine Impurity 22 (CAS 1351436-26-4)
- tert-Butyl 2,5-diazaspiro[3.4]octane-2-carboxylate hemioxalate (CAS 1523618-32-7)
- 3-(2-Bromo-4-chloropyridin-3-yl)oxetan-3-ol (CAS 1434051-16-7)
- 2-(1-Mercaptoethyl)-4-methoxyphenol (CAS 1039963-85-3)
- Betamethasone EP Impurity H (CAS 185613-71-2)
- 2-Chloro-N-isobutylpyrimidin-4-amine (CAS 1201176-19-3)
- 948292-34-0 4,6-Dichloro-8-methylquinoline DTXSID80589020 (CAS 948292-34-0)
- Semaglutide impurity 67 (CAS CATO-C4X-222667)
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