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Safety Information

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:
378-44-9
Molecular Weight:
392.46
MDL number:
MFCD00062969
UNSPSC Code:
41116107
PubChem Substance ID:
329748930
NACRES:
NA.24
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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

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Related Categories

General description

Betamethasone, a synthetic glucocorticoid, belongs to the corticosteroid family of active pharmaceutical ingredients (APIs).[1]
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.

related product

Product No.
Description
Pricing

1067001

Betamethasone acetate, United States Pharmacopeia (USP) Reference Standard

1067704

Betamethasone dipropionate, United States Pharmacopeia (USP) Reference Standard

1069007

Betamethasone valerate, United States Pharmacopeia (USP) Reference Standard

1068004

Betamethasone sodium phosphate, United States Pharmacopeia (USP) Reference Standard

B1055000

Betamethasone 21-valerate, European Pharmacopoeia (EP) Reference Standard

B1054000

Betamethasone 17-valerate, European Pharmacopoeia (EP) Reference Standard

B1000000

Betamethasone, European Pharmacopoeia (EP) Reference Standard

B1030000

Betamethasone acetate, European Pharmacopoeia (EP) Reference Standard

B1040000

Betamethasone dipropionate, European Pharmacopoeia (EP) Reference Standard

B1045000

Betamethasone sodium phosphate, European Pharmacopoeia (EP) Reference Standard

Y0001065

Betamethasone valerate impurity mixture, European Pharmacopoeia (EP) Reference Standard

Y0001027

Betamethasone valerate for system suitability, European Pharmacopoeia (EP) Reference Standard

PHR1399

Betamethasone Dipropionate, Pharmaceutical Secondary Standard; Certified Reference Material

Y0001416

Betamethasone dipropionate for peak identification, European Pharmacopoeia (EP) Reference Standard

1069018

Betamethasone Valerate Related Compound A, United States Pharmacopeia (USP) Reference Standard

1067307

Betamethasone benzoate, United States Pharmacopeia (USP) Reference Standard

PHR1779

Betamethasone Acetate, Pharmaceutical Secondary Standard; Certified Reference Material

PHR1780

Betamethasone Valerate, Pharmaceutical Secondary Standard; Certified Reference Material

Y0001925

Betamethasone dipropionate for system suitability A, European Pharmacopoeia (EP) Reference Standard

BP041

Betamethasone sodium phosphate, British Pharmacopoeia (BP) Reference Standard

BP575

Betamethasone, British Pharmacopoeia (BP) Reference Standard

BP043

Betamethasone 21-valerate, British Pharmacopoeia (BP) Reference Standard

BP042

Betamethasone valerate, British Pharmacopoeia (BP) Reference Standard

1067045

Betamethasone Acetate Related Compound D, United States Pharmacopeia (USP) Reference Standard

1067726

Betamethasone Dipropionate Related Compound B, United States Pharmacopeia (USP) Reference Standard

1067737

Betamethasone Dipropionate Related Compound C, United States Pharmacopeia (USP) Reference Standard

1067760

Betamethasone Dipropionate Related Compound F , United States Pharmacopeia (USP) Reference Standard

1067781

Betamethasone dipropionate Related Compound H, United States Pharmacopeia (USP) Reference Standard

Pictograms

Health hazard
GHS08

Signal Word

Danger

Hazard Statements

H360FD,H373

Hazard Classifications

Repr. 1B - STOT RE 2

Target Organs

Liver,Kidney,Endocrine system

Storage Class Code

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

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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)
    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)
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