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Merck
CN

03936

Supelco

Betamethasone 21-valerate

pharmaceutical impurity standard

Synonym(s):

Betamethasone Related Compound A (USP), Betamethasone impurity E (PhEur)

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About This Item

Empirical Formula (Hill Notation):
C27H37FO6
CAS Number:
2240-28-0
Molecular Weight:
476.58
MDL number:
MFCD00271767
UNSPSC Code:
41116107
PubChem Substance ID:
329747841
NACRES:
NA.24

Key Documents

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grade

analytical standard

Assay

≥95.0% (HPLC)

shelf life

limited shelf life, expiry date on the label

impurities

≤10.0% related substances
≤5.0% solvents
≤5.0% water

application(s)

pharmaceutical (small molecule)

storage temp.

2-8°C

SMILES string

CCCCC(=O)OCC(=O)[C@@]1(O)[C@@H](C)C[C@H]2[C@@H]3CCC4=CC(=O)C=C[C@]4(C)[C@@]3(F)[C@@H](O)C[C@]12C

InChI

1S/C27H37FO6/c1-5-6-7-23(32)34-15-22(31)27(33)16(2)12-20-19-9-8-17-13-18(29)10-11-24(17,3)26(19,28)21(30)14-25(20,27)4/h10-11,13,16,19-21,30,33H,5-9,12,14-15H2,1-4H3/t16-,19-,20-,21-,24-,25-,26-,27-/m0/s1

InChI key

FEROCCAEIIKMJT-SUYDQAKGSA-N

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General description

Betamethasone 21-valerate is an active pharmaceutical ingredient present in various topical pharmaceutical creams.

Application

Betamethasone 21-valerate may be used as a reference standard in the determination of betamethasone 21-valerate in counterfeit drugs using high-performance liquid chromatography coupled with electrospray ionization mass spectrometry (HPLC/ESI‐MS). It may be used as a pharmaceutical impurity standard in the quantification of impurities of betamethasone 21-valerate in topical pharmaceutical creams using high-performance liquid chromatography (HPLC).

Regulatory Information

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Certificates of Analysis (COA)

Lot/Batch Number
BCBS2580V
BCBQ8181V

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An RP-HPLC method for the stability-indicating analysis of impurities of both fusidic acid and betamethasone-17-valerate in a semi-solid pharmaceutical dosage form.
Byrne J, et al.
Journal of Chromatographic Science, 53(9), 1498-1503 (2015)
Metabolism of topical drugs within the skin, in particular glucocorticoids.
K Kubota et al.
Current problems in dermatology, 21, 61-66 (1993-01-01)
F Henry et al.
Skin pharmacology and applied skin physiology, 12(4), 199-210 (1999-07-27)
To assess the effect of the position of a limb (dependency) on the cutaneous vasoconstrictor (blanching) assay (VCA) using topical corticosteroid preparations. Two studies were performed on the forearms of healthy volunteers using tristimulus reflectance colorimetric assessments. The first one
Analysis of betamethasone, dexamethasone and related compounds by liquid chromatography/electrospray mass spectrometry.
Arthur EK, et al.
Rapid Communications in Mass Spectrometry, 18(6), 678-684 (2004)
R De Pasquale et al.
Giornale italiano di dermatologia e venereologia : organo ufficiale, Societa italiana di dermatologia e sifilografia, 145(1), 135-138 (2010-03-04)
Lichen amyloidosis is a primary localized cutaneous amyloidosis without systemic involvement, characterized by a persistent pruritic eruption of multiple discrete hyperkeratotic papules. The etiology is unknown, but chronic irritation of the skin has been proposed as an etiological factor. We
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