B1000000

Betamethasone

European Pharmacopoeia (EP) Reference Standard

Synonym(s):
9α-Fluoro-16β-methyl-11β,17α,21-trihydroxy-1,4-pregnadiene-3,20-dione, 9α-Fluoro-11β,17α,21-trihydroxy-16β-methylpregna-1,4-diene-3,20-dione, 9α-Fluoro-16β-methylprednisolone
Empirical Formula (Hill Notation):
C22H29FO5
CAS Number:
Molecular Weight:
392.46
MDL number:
PubChem Substance ID:
NACRES:
NA.24

biological source

synthetic

grade

pharmaceutical primary standard

Agency/Method

EP

form

neat

packaging

pkg of 60 mg

manufacturer/tradename

EDQM

storage condition

protect from light

color

white

mp

235-237 °C (lit.)
235.6 °C (456.1°F at 1013.0 hPa)

solubility

water: slightly soluble 0.063 g/L at 37 °C

density

0.305 g/cm3 at 25 °C (77°F)

Featured Industry

Pharmaceutical (small molecule)

format

neat

shipped in

ambient

storage temp.

2-8°C

SMILES string

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

InChI

1S/C22H29FO5/c1-12-8-16-15-5-4-13-9-14(25)6-7-19(13,2)21(15,23)17(26)10-20(16,3)22(12,28)18(27)11-24/h6-7,9,12,15-17,24,26,28H,4-5,8,10-11H2,1-3H3/t12-,15-,16-,17-,19-,20-,21-,22-/m0/s1

InChI key

UREBDLICKHMUKA-DVTGEIKXSA-N

Gene Information

human ... NR3C1(2908)

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General description

Betamethasone, a synthetic glucocorticoid, belongs to the corticosteroid family of active pharmaceutical ingredients (APIs).
This product is provided as delivered and specified by the issuing Pharmacopoeia. All information provided in support of this product, including SDS and any product information leaflets have been developed and issued under the Authority of the issuing Pharmacopoeia. For further information and support please go to the website of the issuing Pharmacopoeia.

Application

Betamethasone EP reference standard may be used as a pharmaceutical primary standard for the determination of the analyte in pharmaceutical formulations by chromatographic and spectrophotometric techniques.

Packaging

Unit quantity: 60 mg. Subject to change. The product is delivered as supplied by the issuing Pharmacopoeia. For the current unit quantity, please visit the EDQM reference substance catalogue.

Caution

Other Notes

Sales restrictions may apply.

Pictograms

Health hazard

Signal Word

Danger

Hazard Statements

hazcat

Repr. 1B - STOT RE 2

storage_class_code

6.1C - Combustible, acute toxic Cat.3 / toxic compounds or compounds which causing chronic effects

WGK Germany

WGK 2

Flash Point(F)

Not applicable

Flash Point(C)

Not applicable

Certificate of Analysis

Certificate of Origin

Betamethasone
European Pharmacopoeia Commission and European Directorate for the Quality of Medicines & Healthcare
European pharmacopoeia, 67(3), 4918-4920 (2021)
Simultaneous determination of dexamethasone and betamethasone in pharmaceuticals by reversed-phase HPLC
Santos-Montes A, et al.
Chromatographia, 39(9-10), 539-542 (1994)
Extraction-spectrophotometric method for the determination of betamethasone in pure form and in pharmaceutical formulations
Amin AS and Issa YM
Analytical Letters, 30(1), 69-78 (1997)
Analysis of betamethasone and its organic esters in pharmaceutical products
Graham RE, et al.
Journal of Pharmaceutical Sciences, 67(3), 360-363 (1978)
Method development for betamethasone and dexamethasone by micellar liquid chromatography using cetyl trimethyl ammonium bromide and validation in tablets: Application to cocktails
Pena-Garcia-Brioles D, et al.
Journal of Pharmaceutical and Biomedical Analysis, 36(1), 65-71 (2004)

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