1066009

USP

Betamethasone

United States Pharmacopeia (USP) 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

USP

vapor pressure

<0.0000001 kPa ( 25 °C)

packaging

pkg of 200 mg

manufacturer/tradename

USP

color

white to off-white

mp

235-237 °C (lit.)
447.8-473 °F (231—245°C; decomposes)

solubility

acetone: sparingly soluble
chloroform: very slightly soluble
ethanol: sparingly soluble
ether: very slightly soluble
methanol: sparingly soluble
water: insoluble

density

0.305 g/cm3 at 25 °C (77°F)

Featured Industry

Pharmaceutical (small molecule)

format

neat

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

Analysis Note

These products are for test and assay use only. They are not meant for administration to humans or animals and cannot be used to diagnose, treat, or cure diseases of any kind.  ​

Other Notes

USP issued SDS can be found here.
Sales restrictions may apply.

Pictograms

Health hazard

Signal Word

Danger

Hazard Statements

Precautionary Statements

RIDADR

NONH for all modes of transport

WGK Germany

WGK 2

Flash Point(F)

Not applicable

Flash Point(C)

Not applicable

Certificate of Analysis

Certificate of Origin

Betamethasone
USP43-NF38: United States Pharmacopeia and National Formulary
United States Pharmacopeia, 44(1), 541-541 (2020)
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)
Simultaneous determination of dexamethasone and betamethasone in pharmaceuticals by reversed-phase HPLC
Santos-Montes A, et al.
Chromatographia, 39(9-10), 539-542 (1994)
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)
Protocols
A simple, precise and sensitive Reverse-Phase High Pressure Liquid Chromatography gradient method was adapted for traceability, homogeneity and total chromatographic analysis of Dexamethasone. The given experimental conditions follow the USP43-NF38 monograph method for Dexamethasone Assay and Organic Impurity Profiling. Dexamethasone, Betamethasone, Dexamethasone acetate and Desoximetasone were baseline resolved within 20 minutes using a Titan C18 UHPLC column (2.1 x 100 mm, 1.9 µm).
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