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Betamethasone

European Pharmacopoeia (EP) Reference Standard

Synonym(s):

9α-Fluoro-11β,17α,21-trihydroxy-16β-methylpregna-1,4-diene-3,20-dione, 9α-Fluoro-16β-methyl-11β,17α,21-trihydroxy-1,4-pregnadiene-3,20-dione, 9α-Fluoro-16β-methylprednisolone

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About This Item

Empirical Formula (Hill Notation):
C22H29FO5
CAS Number:
Molecular Weight:
392.46
NACRES:
NA.24
PubChem Substance ID:
UNSPSC Code:
41116107
MDL number:
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biological source

synthetic

grade

pharmaceutical primary standard

agency

EP

API family

betamethasone

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)

application(s)

pharmaceutical (small molecule)

format

neat

shipped in

ambient

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)

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

The product is delivered as supplied by the issuing Pharmacopoeia. For the current unit quantity, please visit the EDQM reference substance catalogue.

Other Notes

Sales restrictions may apply.

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PHR1398BP5751066009
manufacturer/tradename

EDQM

manufacturer/tradename

-

manufacturer/tradename

BP

manufacturer/tradename

USP

grade

pharmaceutical primary standard

grade

certified reference material, pharmaceutical secondary standard

grade

pharmaceutical primary standard

grade

pharmaceutical primary standard

format

neat

format

neat

format

neat

format

neat

application(s)

pharmaceutical (small molecule)

application(s)

pharmaceutical (small molecule)

application(s)

pharmaceutical
pharmaceutical small molecule

application(s)

pharmaceutical (small molecule)

solubility

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

solubility

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

solubility

-

solubility

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

packaging

pkg of 60 mg

packaging

pkg of 1 g

packaging

-

packaging

pkg of 200 mg


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pictograms

Health hazard

signalword

Danger

Hazard Classifications

Repr. 1B - STOT RE 2

target_organs

Liver,Kidney,Endocrine system

Storage Class

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

wgk

WGK 2

flash_point_f

Not applicable

flash_point_c

Not applicable



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Betamethasone
European Pharmacopoeia Commission and European Directorate for the Quality of Medicines & Healthcare
European pharmacopoeia, 67(3), 4918-4920 (2021)
Analysis of betamethasone and its organic esters in pharmaceutical products
Graham RE, et al.
Journal of Pharmaceutical Sciences, 67(3), 360-363 (1978)
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)



Global Trade Item Number

SKUGTIN
B100000004061833420102

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