N-Nitroso Leucine Impurity 1 CAS 78814-91-2
| CAS No. | 78814-91-2 |
| Molecular Formula | C8H14N2O4 |
| Molecular Weight | 202.21 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 N-Nitroso Leucine Impurity 1.
N-Nitroso Leucine Impurity 1 (CAS 78814-91-2) is a certified pharmaceutical impurity reference standard with the molecular formula C8H14N2O4 and a molecular weight of 202.21 g/mol.
Structurally, N-Nitroso Leucine Impurity 1 (C8H14N2O4) contains an amino-acid-derived structure, an amide group, a hydroxyl group, an ether linkage. The molecule exhibits a degree of unsaturation (DBE) of 3.0, corresponding to approximately 3 ring(s) or double-bond equivalent(s). With a molecular weight of 202.21 g/mol, it falls into the medium-molecular-weight range. 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 | C8H14N2O4 |
| Molecular Weight | 202.21 g/mol |
| Appearance | White to pale yellow crystalline powder. (faint amine-like odor) |
| Purity | >95% |
| Storage | Store at 2-8°C, protect from light, keep sealed and dry |
| Solubility (reference) | Soluble in methanol, ethanol, DMSO |
| 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.) | 1979 |
| Nitrogen Atoms | 2 |
Related N Standards
- N-nitroso Cyclen Impurity 127(Gadobutrol Impurity 127) (CAS CATO-C4X-2120127)
- N-Nitroso Buspirone EP Impurity A-d8 (CAS CATO-C4X-125841)
- 3-Methyl-4-nitroso-1-phenyl-1H-pyrazol-5-ol (CAS 87085-88-9)
- 5-Methyl-4-nitroso-2-phenyl-2,4-dihydro-3H-pyrazol-3-one (CAS 56634-85-6)
- Nitroso L-Arginine (CAS 2492451-27-9)
- N-Nitroso Rasagiline-D3 (CAS CATO-C4X-191368)
- 2-(1-nitroso-1H-indol-3-yl)acetic acid (CAS 140843-80-7)
- N-Nitroso Cinacalcet Impurity 9 (CAS CATO-C4X-105980)
Recommended Standards
- Methyl 6-Hydroxy-2-naphthoate (CAS 17295-11-3)
- Tepotinib impurity 22 (CAS 1369761-19-2)
- Ethosuximide impurity 19 (CAS CATO-C4X-262519)
- 2-Naphthoxyacetic Acid (CAS 120-23-0)
- Ibrutinib Impurity 188 (CAS CATO-C4X-1064188)
- Cefcapene Impurity 95 (CAS CATO-C4X-182495)
- Parecoxib Impurity 52 (CAS 2304623-37-6)
- Pentafluoro(4-phenoxyphenyl)-lambda6-sulfane (CAS 1126968-86-2)
- 5-Oxopyrrolidin-3-yl (4-methoxyphenyl)carbamate (CAS 88015-92-3)
- N-(2-ethoxybenzyl)ethanamine (CAS 869942-06-3)
- H-Glu(4MβNA)-OH (CAS 24723-50-0)
- (R)-2-((tert-butoxycarbonyl)amino)-4-(3,4-difluorophenyl)butanoic acid (CAS 1260588-78-0)
- 2-(2-(4-(Dibenzo[b,f][1,4]thiazepin-11-yl)piperazin-1-yl)ethoxy-1,1,2,2-d4)ethan-1-ol (CAS 1031703-35-1)
- Semaglutide impurity 78 (CAS CATO-C4X-222678)
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