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Merck
CN

1066009

USP

Betamethasone

United States Pharmacopeia (USP) 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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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

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 key

UREBDLICKHMUKA-DVTGEIKXSA-N

biological source

synthetic

grade

pharmaceutical primary standard

agency

USP

vapor pressure

<0.0000001 kPa ( 25 °C)

API family

betamethasone

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)

application(s)

pharmaceutical (small molecule)

format

neat

storage temp.

2-8°C

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, intended for use in specified quality tests and assays as specified in the USP compendia. Also, for use with USP monographs such as:
  • Betamethasone Acetate
  • Betamethasone Oral Solution
  • Betamethasone Valerate Cream
  • Betamethasone Valerate Lotion
  • Betamethasone Valerate Ointment
  • Dexamethasone

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

Sales restrictions may apply.

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

Regulatory Information

监管及禁止进口产品
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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)
Simultaneous determination of dexamethasone and betamethasone in pharmaceuticals by reversed-phase HPLC
Santos-Montes A, et al.
Chromatographia, 39(9-10), 539-542 (1994)
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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