Hydrocortisone EP Impurity M CAS 566-35-8
| CAS No. | 566-35-8 |
| Molecular Formula | C21H30O5 |
| Molecular Weight | 362.46 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
The occurrence of Hydrocortisone EP Impurity M is closely related to a flavonoid core, a hydroxyl group, an ether linkage in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.
Hydrocortisone EP Impurity M (CAS 566-35-8) is a certified pharmaceutical impurity reference standard with the molecular formula C21H30O5 and a molecular weight of 362.46 g/mol.
Hydrocortisone EP Impurity M (C21H30O5) contains a flavonoid core, a hydroxyl group, an ether linkage. 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 | C21H30O5 |
| Molecular Weight | 362.46 g/mol |
| Appearance | Off-white to pale yellow crystalline powder |
| Purity | >95% |
| Storage | Store at 2-8°C, 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) | 7.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 1957 |
Related Hydrocortisone Standards
- Hydrocortisone Degradation ProductDISCONTINUED. Offer D229160 (CAS 1960421-03-7)
- Hydrocortisone Impurity 18 (CAS 27149-68-4)
- Hydrocortisone Impurity 53 (CAS 80753-80-6)
- Hydrocortisone Impurity 56 (CAS CATO-C4X-140156)
- Hydrocortisone (CAS 50-23-7)
- Hydrocortisone (9beta,11beta)-Epoxide (CAS 10072-97-6)
- Hydrocortisone EP Impurity A (CAS 50-24-8)
- Hydrocortisone EP Impurity E (CAS 600-99-7)
Recommended Standards
- Solifenacin EP impurity G (CAS 740780-79-4)
- Solifenacin Succinate EP Impurity F (CAS 774517-20-3)
- Solifenacin EP Impurity H (CAS 732228-02-3)
- Loxoprofen Impurity 113 (CAS CATO-C4X-1488113)
- Ceritinib Impurity 74 (CAS CATO-C4X-104874)
- Pregabalin Impurity 130 (CAS CATO-C4X-1312130)
- Pimavanserin Impurity 41 (CAS CATO-C4X-193841)
- 1-Benzyl-6-chloro-1h,2h,3h-pyrrolo[3,2-c]pyridine-7-carbonitrile (CAS 66751-32-4)
- 2-Amino-N-[(benzylcarbamoyl)methyl]acetamide hydrochloride (CAS 1579198-56-3)
- 3-(5-((2,4-Dichlorobenzyl)thio)-4-phenyl-4H-1,2,4-triazol-3-yl)pyridine (CAS 444153-03-1)
- 4-Bromo-2-ethoxyaniline (CAS 57279-73-9)
- tert-Butyl 6-aminooctahydro-1H-cyclopenta[b]pyridine-1-carboxylate (CAS 1559394-24-9)
- Ethyl (5-chloro-1,3,4-thiadiazol-2-yl)carbamate (CAS 60320-58-3)
- Semaglutide Impurity 191 (CAS CATO-C4X-2226191)
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