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13951-70-7Budesonide EP Impurity A

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Catalogue No.:	VL34001
CAS No.:	13951-70-7
Mol. Formula:	C21H28O6
Mol. Weight:	376.44 g/mol

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Additional information on CAS 13951-70-7

Parent drug

Budesonide/ Prednisolone/ Desonide

IUPAC Name

11β,16α,17,21-Tetrahydroxypregna-1,4-diene-3,20-dione

Pharmacopeial Synonyms

16α-Hydroxy prednisolone

Synonyms

Desonide Impurity A; (8S,9S,10R,11S,13S,14S,16R,17S)-11,16,17-trihydroxy-17-(2-hydroxyacetyl)-10,13-dimethyl-7,8,9,11,12,14,15,16-octahydro-6H-cyclopenta[a]phenanthren-3-one; Pregna-1,4-diene-3,20-dione, 11,16,17,21-tetrahydroxy-, (11b,16a)-

Smiles

C[C@]12C[C@@H]([C@H]3[C@H]([C@@H]1C[C@H]([C@@]2(C(=O)CO)O)O)CCC4=CC(=O)C=C[C@]34C)O

InChI

InChI=1S/C21H28O6/c1-19-6-5-12(23)7-11(19)3-4-13-14-8-16(25)21(27,17(26)10-22)20(14,2)9-15(24)18(13)19/h5-7,13-16,18,22,24-25,27H,3-4,8-10H2,1-2H3/t13-,14-,15-,16+,18+,19-,20-,21-/m0/s1

Shipping Condition

Ambient Temperature

Description

Budesonide EP Impurity A, also designated 16α-Hydroxy prednisolone or Desonide Impurity A, is a corticosteroid-related process and degradation impurity with CAS 13951-70-7. It corresponds to C21H28O6 and a molecular weight of 376.44 g/mol. Structurally, it is a hydroxylated prednisolone-type steroid bearing the 16α-hydroxy functionality, which reflects altered oxidative or biotransformational pathways within the pregnane framework. Because of its close structural similarity to active glucocorticoids, its determination typically requires selective LC-MS/MS or LC-HRMS, often supported by HPLC-UV for profile characterization. It is not a nitrosamine, and no specific ICH M7 concern is established.