| CAS No. | 201340-97-8 |
| Molecular Formula | C18H28N5O10P |
| Molecular Weight | N/A |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
CATO supplies Tenofovir Disoproxil Impurity 44 (CAS 201340-97-8), a pharmacopoeial impurity reference standard (molecular formula C18H28N5O10PC4H4O4, MW 621.49 g/mol) used for the identification and quantification of trace impurities in APIs.
Owing to a flavonoid core, an amide group, a phosphate ester group, a hydroxyl group, an ether linkage, Tenofovir Disoproxil Impurity 44 is typically pale yellow to yellow amorphous powder. Its solid-state physicochemical attributes — including a molecular weight of 621.49 g/mol — guide the selection of appropriate sample preparation and analytical techniques. 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.
As a certified reference material (CRM), Tenofovir Disoproxil Impurity 44 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.
| Molecular Formula | C18H28N5O10P C4H4O4 |
| Molecular Weight | 621.49 g/mol |
| Purity | 97%+ |
| 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) | 9.5 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 2014 |
| Nitrogen Atoms | 5 |