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Merck
CN

03936

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:
Molecular Weight:
476.58
NACRES:
NA.24
PubChem Substance ID:
UNSPSC Code:
41116107
MDL number:
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grade

analytical standard

Quality Level

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

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).


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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)
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)
K Kubota et al.
Dermatology (Basel, Switzerland), 188(1), 13-17 (1994-01-01)
The metabolism of betamethasone 17-valerate was estimated using an artificial living skin equivalent (LSE). Betamethasone 17-valerate, betamethasone 21-valerate and betamethasone were measured by a normal-phase high-performance liquid chromatographic (HPLC) method. Betamethasone 17-valerate was added to the culture medium with or