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Includes: HPLC, MASS/LC-MS, 1H NMR, FT-IR, Potency, Structure Elucidation Report (SER), and additional analytical data depending on the product.

53-03-2Prednisolone EP Impurity B

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Catalogue No.:	VE007735
CAS No.:	53-03-2
Mol. Formula:	C21H26O5
Mol. Weight:	358.43 g/mol

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Additional information on CAS 53-03-2

Parent drug

Prednisolone

IUPAC Name

17,21-Dihydroxypregna-1,4-diene-3,11,20-trione

Pharmacopeial Synonyms

N/A

Synonyms

1,4-Pregnadiene-17alpha,21-diol-3,11,20-trione; (8S,9S,10R,13S,14S,17R)-17-hydroxy-17-(2-hydroxyacetyl)-10,13-dimethyl-6,7,8,9,12,14,15,16-octahydrocyclopenta[a]phenanthrene-3,11-dione

Smiles

C[C@@]1(C2)[C@](C(CO)=O)(O)CC[C@@]1([H])[C@]3([H])CCC4=CC(C=C[C@]4(C)[C@@]3([H])C2=O)=O

InChI

InChI=1S/C21H26O5/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/h5,7,9,14-15,18,22,26H,3-4,6,8,10-11H2,1-2H3/t14-,15-,18+,19-,20-,21-/m0/s1

Characterization Data (Included)

HPLC, MASS/LC-MS, 1H NMR, FT-IR, Potency, and Structure Elucidation Report (SER).

Additional Characterization Data

QNMR, D2O Exchange, 13C NMR, 13C APT, COSY NMR, NOESY NMR, 15N NMR, HSQC NMR, HMQC NMR, and HMBC NMR. These are available upon request and may be free or subject to additional charges.

Shipping Condition

Ambient Temperature

Description

Prednisolone EP Impurity B (CAS 53-03-2) is a steroidal process- and/or degradation-related impurity structurally assigned to 1,4-pregnadiene-17alpha,21-diol-3,11,20-trione, with molecular formula C21H26O5 and molecular weight 358.43 g/mol. The molecule retains the corticosteroid tetracyclic scaffold but differs from prednisolone by oxidation state and side-chain functionality, consistent with oxidative rearrangement or synthetic intermediate carryover. Because structurally related corticosteroid impurities may influence assay specificity and stability-indicating methods, its measurement typically relies on LC-MS/MS, high-resolution LC-MS, and impurity-resolved HPLC with UV detection, supported by orthogonal spectral confirmation.