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50-24-8Hydrocortisone EP Impurity A

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Catalogue No.:	VE006173
CAS No.:	50-24-8
Mol. Formula:	C21H28O5
Mol. Weight:	360.44 g/mol

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Additional information on CAS 50-24-8

Parent drug

Hydrocortisone/ Prednicarbate/ Prednisone/ Methylprednisolone

IUPAC Name

11β,17,21-trihydroxypregna-1,4-diene-3,20-dione

Pharmacopeial Synonyms

Prednisolone; Prednisolone Acetate EP Impurity B; Prednicarbate EP Impurity A; Prednisone EP Impurity B; Methylprednisolone EP Impurity K

Synonyms

8S,9S,10R,11S,13S,14S,17R)-11,17-dihydroxy-17-(2-hydroxyacetyl)-10,13-dimethyl-7,8,9,11,12,14,15,16-octahydro-6H-cyclopenta[a]phenanthren-3-one

Smiles

O=C1C=C[C@]2(C)[C@@]3([H])[C@](O)([H])C[C@]4(C)[C@](C(CO)=O)(O)CC[C@@]4([H])[C@]3([H])CCC2=C1

InChI

InChI=1S/C21H28O5/c1-19-7-5-13(23)9-12(19)3-4-14-15-6-8-21(26,17(25)11-22)20(15,2)10-16(24)18(14)19/h5,7,9,14-16,18,22,24,26H,3-4,6,8,10-11H2,1-2H3/t14-,15-,16-,18+,19-,20-,21-/m0/s1

Shipping Condition

Ambient Temperature

Description

Hydrocortisone EP Impurity A, also recognized as prednisolone and related compendial impurity designations, is the 11β,17α-dihydroxy-1,4-pregnadiene-3,20-dione corticosteroid nucleus bearing CAS 50-24-8, molecular formula C21H28O5, and molecular weight 360.44 g/mol. It is a structurally defined steroidal process-related and degradative impurity arising through oxidation, Δ1,2 isomerization, or selective dehydrogenation within glucocorticoid manufacturing and storage. Because of close chromatographic behavior with parent corticosteroids, quantification often requires LC-MS/MS, HPLC with diode-array detection, and occasionally GC-MS after derivatization. It is not a nitrosamine and is not classically addressed under ICH M7.