Famciclovir Impurity 36 CAS 172645-79-3
| CAS No. | 172645-79-3 |
| Molecular Formula | C14H19N5O5 |
| Molecular Weight | 337.33 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 Famciclovir Impurity 36.
Famciclovir Impurity 36 (CAS 172645-79-3) is a certified pharmaceutical impurity reference standard with the molecular formula C14H19N5O5 and a molecular weight of 337.33 g/mol.
Structurally, Famciclovir Impurity 36 (C14H19N5O5) contains a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage. The molecule exhibits a degree of unsaturation (DBE) of 8.0, corresponding to approximately 8 ring(s) or double-bond equivalent(s). With a molecular weight of 337.33 g/mol, it falls into the moderately-high-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 | C14H19N5O5 |
| Molecular Weight | 337.33 g/mol |
| Appearance | Pale yellow to yellow crystalline powder |
| Purity | 97%+ |
| Storage | Store at 2-8°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) | 8.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 2006 |
| Nitrogen Atoms | 5 |
Related Famciclovir Standards
- Famciclovir Impurity 22 (CAS CATO-C4X-164222)
- Famciclovir Impurity 4 (CAS 172529-93-0)
- Famciclovir-d4 (CAS 1020719-42-9)
- Famciclovir Impurity 5 (CAS CATO-C4X-16425)
- Famciclovir Impurity 8 (CAS 126589-69-3)
- Famciclovir N7-Isomer (CAS 131266-15-4)
- Famciclovir (CAS 104227-87-4)
- Famciclovir Impurity 3 (CAS CATO-C4X-16423)
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