Pirfenidone Impurity 35 CAS 2412-49-9
| CAS No. | 2412-49-9 |
| Molecular Formula | C10H16N2 |
| Molecular Weight | 164.25 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
As a certified reference material (CRM), Pirfenidone Impurity 35 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.
CATO supplies Pirfenidone Impurity 35 (CAS 2412-49-9), a pharmacopoeial impurity reference standard (molecular formula C10H16N2, MW 164.25 g/mol) used for the identification and quantification of trace impurities in APIs.
Owing to a nitrogen-containing heterocyclic scaffold, a nitrile group, Pirfenidone Impurity 35 is typically off-white to pale yellow crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 164.25 g/mol — guide the selection of appropriate sample preparation and analytical techniques. The high carbon-to-hydrogen ratio imparts good lipophilicity, allowing liquid-liquid extraction with non-polar solvents such as n-hexane or ethyl acetate.
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.
Physical & Chemical Properties
| Molecular Formula | C10H16N2 |
| Molecular Weight | 164.25 g/mol |
| Appearance | Off-white to pale yellow crystalline powder. (faint amine-like odor) |
| Purity | 97%+ |
| Storage | Store at 2-8°C, protect from light |
| Solubility (reference) | Soluble in DMSO, DMF, methanol |
| Stability | Light-sensitive; avoid direct strong light |
| Degree of Unsaturation (DBE) | 4.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 1957 |
| Nitrogen Atoms | 2 |
Related Pirfenidone Standards
- Pirfenidone Impurity 32 (CAS 92-53-5)
- Pirfenidone Impurity 33 (CAS 108-86-1)
- Pirfenidone Impurity 42 (CAS 3510-66-5)
- Pirfenidone Impurity 43 (CAS 7464-14-4)
- Pirfenidone Impurity 44 (CAS 21901-18-8)
- Pirfenidone (CAS 53179-13-8)
- Pirfenidone Impurity 14 (CAS 51933-81-4)
- Pirfenidone Impurity 29 (CAS 53427-93-3)
Recommended Standards
- 1-Ethyl-6-methyl-1,2,3,4-tetrahydro-pyrrolo[1,2-a]pyrazine 1330AF 876715-62-7 C10H16N2 (CAS 876715-62-7)
- N,N,N＇,N＇-Tetramethyl-p-phenylenediamine (CAS 100-22-1)
- 622373-91-5 N~1~-[(2-Methylphenyl)methyl]ethane-1,2-diamine DTXSID30608593 (CAS 622373-91-5)
- N,N-Diethyl-p-phenylenediamine (CAS 93-05-0)
- Pantoprazole Impurity 77 (CAS CATO-C4X-139977)
- Posaconazole impurity 230 (CAS CATO-C4X-1208230)
- Tryptophan EP Impurity H (CAS 6052-68-2)
- Flunitrazepam-D7 (CAS 1286448-08-5)
- 3,5,5-Trimethylhexyl 3,5,5-trimethylhexanoate (CAS 59219-71-5)
- [S(R)]-N-[(1S)-1-[2-(Di-tert-butylphosphanyl)phenyl]phenylmethyl]-N,2-dimethyl-2-propanesulfinamide (CAS 2253984-99-3)
- ((2S,4S)-2-methylpiperidin-4-yl)methanol hydrochloride (CAS 1807939-86-1)
- 1-Bromopentane-1,1,2,2-d4 (CAS 1219803-61-8)
- 3-(2-Ethylbutanamido)benzoic acid (CAS 915923-97-6)
- Semaglutide impurity 109 (CAS CATO-C4X-2226109)
Why CATO?
- ISO 17034 accredited reference material producer (CNAS + ANAB dual accreditation)
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- Technical support: +86 18665070610 / Nicole.chen@cato-chem.com