Tacrolimus impurity 44 CAS 135635-46-0
| CAS No. | 135635-46-0 |
| Molecular Formula | C43H69NO12 |
| Molecular Weight | 792.01 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 Tacrolimus impurity 44.
Tacrolimus impurity 44 (CAS 135635-46-0) is a certified pharmaceutical impurity reference standard with the molecular formula C43H69NO12 and a molecular weight of 792.01 g/mol.
Structurally, Tacrolimus impurity 44 (C43H69NO12) contains a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage. The molecule exhibits a degree of unsaturation (DBE) of 10.0, corresponding to approximately 10 ring(s) or double-bond equivalent(s). With a molecular weight of 792.01 g/mol, it falls into the high-molecular-weight range. 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 | C43H69NO12 |
| Molecular Weight | 792.01 g/mol |
| Purity | >85% |
| Storage | Store at room temperature, protect from light, keep sealed and dry |
| Solubility (reference) | Soluble in methanol, acetonitrile, DMSO, water (slightly soluble) |
| Stability | May oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light |
| Degree of Unsaturation (DBE) | 10.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 1995 |
| Nitrogen Atoms | 1 |
Related Tacrolimus Standards
- Tacrolimus EP Impurity B (CAS CATO-C4X-130045)
- Tacrolimus Impurity 53 (CAS CATO-C4X-130053)
- Tacrolimus EP Impurity A (CAS 104987-12-4)
- Tacrolimus impurity 71 (CAS CATO-C4X-130071)
- Tacrolimus 31 DMT (CAS 135635-47-1)
- Tacrolimus 15-DMT (CAS 151039-41-7)
- Tacrolimus 31-DMT (CAS 127984-76-3)
- Tacrolimus EP Impurity C (CAS CATO-C4X-130025)
Recommended Standards
- Triethyl 5,5',5''-((nitrilotris(methylene))tris(1H-benzo[d]imidazole-2,1-diyl))tripentanoate (CAS 956299-56-2)
- Band 3 Protein (824-829) (human) H-Tyr-Val-Lys-Arg-Val-Lys-OH (CAS 158475-15-1)
- DPP48-DCV-Br (CAS 2059936-87-5)
- Velpatasvir Impurity 2 (CAS 1378391-45-7)
- Vitamin K1 Impurity 60 (CAS 2580987-83-1)
- Bisoprolol Impurity 63 (CAS 704200-67-9)
- Pregabalin Impurity 119 (CAS CATO-C4X-1312119)
- Methyl 1-Phenanthroate (CAS 25308-62-7)
- Promethazine impurity 58 (CAS CATO-C4X-141858)
- 1-(2,4-Dimethyl-1H-imidazol-5-yl)thiourea (CAS 750643-45-9)
- Ertugliflozin impurity 18 (CAS 1210344-55-0)
- Thienyl Fentanyl-d3 Hydrochloride (1.0mg/ml in Acetonitrile) (CAS 1189677-23-3)
- Ethyl 4-(methylthio)-2-thioxo-3-(p-tolyl)-2,3-dihydrothiazole-5-carboxylate (CAS 478261-54-0)
- Semaglutide impurity 201 (CAS CATO-C4X-2226201)
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