Mycophenolate Mofetil EP Impurity B CAS 1094322-91-4
| CAS No. | 1094322-91-4 |
| Molecular Formula | C29H42N2O9 |
| Molecular Weight | 562.65 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
Recommended for quantitative analysis by HPLC, GC, LC-MS/MS, or GC-MS as an external calibration standard; it can also be used for spiked-recovery experiments, LOD/LOQ determination, and LC-MS/MS multiple-reaction-monitoring (MRM) calibration.
As a process- or degradation-related impurity, Mycophenolate Mofetil EP Impurity B (CAS 1094322-91-4, C29H42N2O9) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
Mycophenolate Mofetil EP Impurity B (C29H42N2O9) contains a nitrogen-containing heterocyclic scaffold, 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 aromatic system may exhibit native fluorescence, enabling detection with a fluorescence detector (FLD).
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 | C29H42N2O9 |
| Molecular Weight | 562.65 g/mol |
| Appearance | Pale yellow to yellow crystalline powder |
| 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) | 10.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 1989 |
| Nitrogen Atoms | 2 |
Related Mycophenolate Standards
- Mycophenolate Impurity 23 (CAS CATO-C4X-151523)
- Mycophenolate Mofetil EP Impurity G (CAS 224052-51-1)
- Mycophenolate Mofetil EP Impurity D (CAS 1322681-37-7)
- Mycophenolate Mofetil-d4 (CAS 1132748-21-0)
- Mycophenolate Mofetil (Mixture of E and Z Isomers) (CAS 1076198-64-5)
- Mycophenolate Mofetil (CAS 128794-94-5)
- Mycophenolate Mofetil EP Impurity C (Z-isomer) (CAS 2286278-51-9)
- Mycophenolate Mofetil (CAS 115007-34-6)
Recommended Standards
- 18,21-didehydro-17-demethoxy-18,21-dideoxo-18,21-dihydroxy-15R-methoxy-geldanamycin 91700-91-3 (CAS 91700-91-3)
- Fmoc-(α-Me)-L-Phe-(α-Me)-L-Phe-OH (CAS 2978738-77-9)
- Nonacosan-15-ylbenzene (CAS 56247-97-3)
- 4,6-Bis(3-(9H-carbazol-9-yl)phenyl)pyrimidine (CAS 1262678-77-2)
- Dopamine Impurity 100 (CAS CATO-C4X-1908100)
- Ibutilide Impurity 13 (CAS CATO-C4X-211013)
- Dexmedetomidine Impurity 50 (CAS 583-71-1)
- 4-Butyl-4'-ethynyl-1,1'-biphenyl (CAS 136723-70-1)
- 2-Bromo-3-(chloromethyl)-4-fluoro-1-nitrobenzene (CAS 1805248-59-2)
- Piribedil-d8 (CAS 1398044-45-5)
- 5,7-Dichloro-3-iodoquinolin-4(1H)-one (CAS 1593344-58-1)
- 2-Chloro-4-(m-tolylamino)pyrimidine-5-carboxylic acid (CAS 227449-26-5)
- 6-Benzyloxy-1H-indazole-3-carboxylic Acid (CAS 865887-11-2)
- Tirzepatide Impurity 58 (CAS CATO-C4X-324058)
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