Tenofovir disoproxil Impurity 4 CAS 1217542-13-6(Free base)
| CAS No. | 1217542-13-6(Free base) |
| Molecular Formula | C19H30N5O10P |
| Molecular Weight | N/A |
| 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 Tenofovir disoproxil Impurity 4.
Tenofovir disoproxil Impurity 4 (CAS 1217542-13-6(Free base)) is a certified pharmaceutical impurity reference standard with the molecular formula C19H30N5O10PC4H4O4 and a molecular weight of 635.52 g/mol.
Tenofovir disoproxil Impurity 4 (C19H30N5O10PC4H4O4) contains a flavonoid core, an amide group, a phosphate ester group, a hydroxyl group, an ether linkage. It is notably hygroscopic, the carboxyl group imparts weak acidity; these physicochemical properties determine the optimal preparation and storage of its standard solutions. The aromatic system may exhibit native fluorescence, enabling detection with a fluorescence detector (FLD).
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 | C19H30N5O10P C4H4O4 |
| Molecular Weight | 635.52 g/mol |
| Purity | >95% |
| 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 |
| Nitrogen Atoms | 5 |
Related Tenofovir Standards
- Tenofovir alafenamide Impurity 79 (CAS 102-10-3)
- rac Tenofovir-d6 (CAS 1020719-94-1)
- Tenofovir disoproxil Impurity 142 (CAS 102537-97-3)
- Tenofovir Disoproxil Dimer (CAS 1093279-76-5)
- Tenofovir disoproxil Impurity 6 (CAS 1093279-77-6)
- Tenofovir disoproxil Impurity 28 (CAS 1115-59-9)
- Tenofovir Impurity 59 (CAS 116384-56-6)
- Tenofovir alafenamide impurity 85 (CAS 121149-98-2)
Recommended Standards
- Adenosine Impurity 19 (CAS 166735-83-7)
- Pramipexole Impurity 57 (CAS CATO-C4X-110757)
- Dolutegravir Impurity 17 (CAS CATO-C4X-162017)
- 4-Cyano-5-(difluoromethyl)-2-iodonicotinoyl chloride (CAS 1805086-18-3)
- 5-Bromo-N-(2,2-dimethylthietan-3-yl)furan-2-carboxamide (CAS 1866969-66-5)
- 2,2-Bis(4-aminophenyl)hexafluoropropane (CAS 1095-78-9)
- Endotoxin Inhibitor (CAS 147396-10-9)
- 2-[1-(Aminomethyl)cyclopropyl]acetic acid (CAS 1520003-13-7)
- (R)-1-(2,3-dimethylphenyl)propan-1-amine hydrochloride (CAS 856563-02-5)
- Neuroendocrine Regulatory Peptide-4 (human, mouse, rat) (H-7266.1000) (CAS 922704-18-5)
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