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PHR1398

Betamethasone

Pharmaceutical Secondary Standard; Certified Reference Material

Synonym(s):

Betamethasone, 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
NACRES:
NA.24
PubChem Substance ID:
329823372
UNSPSC Code:
41116107
EC Number:
206-825-4
MDL number:
MFCD00062969
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biological source

synthetic

Quality Level

300

grade

certified reference material, pharmaceutical secondary standard

agency

BP, EP, USP, traceable to Ph. Eur. B1000000, traceable to USP 1066009

vapor pressure

<0.0000001 kPa ( 25 °C)

API family

betamethasone

CofA

current certificate can be downloaded

packaging

pkg of 1 g

storage condition

protect from light (20 mm aluminium crimp seal for unused portion)

technique(s)

HPLC: suitable, gas chromatography (GC): suitable

color

white to light yellow

mp

235-237 °C (lit.)

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

shipped in

ambient

storage temp.

2-30°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)

General description

Pharmaceutical secondary standards for application in quality control, provide pharma laboratories and manufacturers with a convenient and cost-effective alternative to the preparation of in-house working standards.
Betamethasone belongs to the corticosteriod family of active pharmaceutical ingredients (APIs). It exhibits anti-inflammatory activity and hence is used in the manufacture of various finished pharmaceutical products and is also employed as a starting material to manufacture other APIs that are related to this steroid family.

Application

Betamethasone may be used as a pharmaceutical reference standard for the quantification of the analyte in pharmaceutical formulations by using micellar liquid chromatography technique and reversed-phase high-performance liquid chromatography technique.
These Secondary Standards are qualified as Certified Reference Materials. These are suitable for use in several analytical applications including but not limited to pharma release testing, pharma method development for qualitative and quantitative analyses, food and beverage quality control testing, and other calibration requirements.

Analysis Note

These secondary standards offer multi-traceability to the USP and EP primary standards, where they are available.

Other Notes

This Certified Reference Material (CRM) is produced and certified in accordance with ISO 17034 and ISO/IEC 17025. All information regarding the use of this CRM can be found on the certificate of analysis.
To see an example of a Certificate of Analysis for this material enter LRAA2174 in the slot below. This is an example certificate only and may not be the lot that you receive.

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pictograms

Health hazard
GHS08

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

This item has

Certificates of Analysis (COA)

Search for Certificates of Analysis (COA) by entering the products Lot/Batch Number. Lot and Batch Numbers can be found on a product’s label following the words ‘Lot’ or ‘Batch’.

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Simultaneous determination of dexamethasone and betamethasone in pharmaceuticals by reversed-phase HPLC
Pena-Garcia-Brioles D, et al.
Chromatographia, 39(9), 539-542 (1994)
Development and validation of a stability-indicating RP-HPLC method to separate low levels of dexamethasone and other related compounds from betamethasone
Xiong Y, et al.
Journal of Pharmaceutical and Biomedical Analysis, 49(3), 646-654 (2009)
Amelia Ruffatti et al.
Autoimmunity reviews, 12(7), 768-773 (2013-01-24)
The aim of this report was to evaluate the efficacy and safety of a combined treatment protocol used to treat 2nd and 3rd degree anti-Ro/La-related congenital atrioventricular block (CAVB). Six consecutive women diagnosed with 2nd degree (three cases) or 3rd
View All Related Papers

Global Trade Item Number

SKUGTIN
PHR1398-1G04061835233977