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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.

14622-47-0Dexamethasone EP Impurity I

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Catalogue No.:	VL273006
CAS No.:	14622-47-0
Mol. Formula:	C22H28O5
Mol. Weight:	372.45 g/mol

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Additional information on CAS 14622-47-0

Parent drug

Dexamethasone

IUPAC Name

9α,11α-Epoxy-17,21-dihydroxy-16α-methylpregna-1,4-diene-3,20-dione

Pharmacopoeial Synonyms

N/A

Other Synonyms

Dexamethasone 9, 11- α Epoxide

Smile

C[C@@]12[C@](C(CO)=O)(O)[C@H](C)C[C@@]1([H])[C@]3([H])CCC4=CC(C=C[C@]4(C)[C@@]3(O5)[C@H]5C2)=O

InChI

InChI=1S/C22H28O5/c1-12-8-16-15-5-4-13-9-14(24)6-7-19(13,2)22(15)18(27-22)10-20(16,3)21(12,26)17(25)11-23/h6-7,9,12,15-16,18,23,26H,4-5,8,10-11H2,1-3H3/t12-,15+,16+,18-,19+,20+,21+,22+/m1/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.

Description

Dexamethasone EP Impurity I is a meticulously characterized reference material that complies with rigorous regulatory requirements, including those defined by USP, EMA, JP, and BP. This product plays a crucial role in Abbreviated New Drug Applications (ANDA), New Drug Applications (NDA), and the commercial manufacturing of Dexamethasone. It is further supported by a detailed Structure Elucidation Report (SER), ensuring high accuracy and reliability across a broad range of analytical applications. Dexamethasone EP Impurity I is an impurity of Dexamethasone. It is also chemically known as Dexamethasone-9(11)-α-Epoxide. It is an impurity formed in dexamethasone that depicts an influential role and has been broadly utilized in the treatment of inflammation, allergy, and diseases linked to adrenal cortex insufficiency therapy.

References

Das, Saibal Kumar, et al. “Improvements in Corticosteroid 21-Acetoxy-17a-Hydroxy-16a-Methyl-Pregna-1, 4, 9(11)-Triene-3, 20-Dione Synthesis and Its Use as Common Intermediate in the Synthesis of Some Impurities Related to Dexamethasone and Mometasone.” Steroids, vol. 148, Aug. 2019, pp. 47–55, https://doi.org/10.1016/j.steroids.2019.04.008.?