Tadalafil Impurity 35 CAS 2169996-11-4
| CAS No. | 2169996-11-4 |
| Molecular Formula | C24H25N3O5 |
| Molecular Weight | 435.47 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 Tadalafil Impurity 35.
Tadalafil Impurity 35 (CAS 2169996-11-4) is a certified pharmaceutical impurity reference standard with the molecular formula C24H25N3O5 and a molecular weight of 435.47 g/mol.
Tadalafil Impurity 35 (C24H25N3O5) contains a flavonoid core, an amide 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 presence of an aromatic ring or conjugated system gives the compound characteristic absorption bands in the UV-Vis region, making it well suited to UV or diode-array detection (DAD).
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 | C24H25N3O5 |
| Molecular Weight | 435.47 g/mol |
| Appearance | Pale yellow to yellow crystalline powder |
| 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) | 14.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 1998 |
| Nitrogen Atoms | 3 |
Related Tadalafil Standards
- Tadalafil Impurity 59 (CAS CATO-C4X-108759)
- Tadalafil Impurity 157 (CAS CATO-C4X-1087157)
- Tadalafil Impurity 177 (CAS CATO-C4X-1087177)
- Tadalafil Impurity 91 (CAS CATO-C4X-108791)
- Tadalafil Impurity 123 (CAS 2520114-73-0)
- Tadalafil Impurity 182 (CAS 2237219-65-5)
- Tadalafil Impurity 183 (CAS CATO-C4X-1087183)
- Tadalafil Impurity 158 (CAS 1863191-32-5)
Recommended Standards
- Erlotinib Impurity 48 (CAS 2055840-54-3)
- Trimazosin Hydrochloride (CAS 35795-16-5)
- Carvedilol Impurity 26 (CAS 2248746-67-8)
- N-(Benzo[d][1,3]dioxol-5-yl)-1-(2-(2-oxopyrrolidin-1-yl)benzoyl)piperidine-4-carboxamide (CAS 924254-69-3)
- Carprofen EP Impurity D (CAS 92841-22-0)
- Lifitegrast Impurity 25 (CAS CATO-C4X-240925)
- (S)-2-Amino-3-(4-(4,4,5,5-tetramethyl-1,3,2-dioxaborolan-2-yl)phenyl)propanoic acid (CAS 878384-69-1)
- 2,4-Dimethyl-1-penten-3-ol (CAS 19781-54-5)
- (R)-(-)-Citramalic Acid DISCONTINUED PLEASE SEE C525525 (CAS 6236-10-8)
- 4-(4-aminopiperidin-1-yl)-N,N-dimethylbenzenesulfonamide hydrochloride (CAS 1185310-65-9)
- 2-Chlorobenzo[d]oxazole-6-carboxylic acid (CAS 1198793-52-0)
- 4-Iodo-3-methoxy-2-(trifluoromethoxy)pyridine-5-sulfonyl chloride (CAS 1804362-47-7)
- 3-Acetyl-5-(trifluoromethyl)benzoic acid (CAS 1393583-81-7)
- Tau Peptide (301-315) trifluoroacetate salt (CAS 330456-48-9)
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