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PHR1398

Supelco

Betamethasone

Pharmaceutical Secondary Standard; Certified Reference Material

Synonym(s):
Betamethasone, 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
EC Number:
MDL number:
PubChem Substance ID:

Quality Level

biological source

synthetic

grade

certified reference material
pharmaceutical secondary standard

Agency/Method

BP
EP
USP

vapor pressure

<0.0000001 kPa ( 25 °C)

CofA

current certificate can be downloaded

packaging

pkg of 1 g

storage condition

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

application(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)

Featured Industry

Pharmaceutical (small molecule)

format

neat

pharmacopeia traceability

traceable to BP 575
traceable to PhEur B1000000
traceable to USP 1066009

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)

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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

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.
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.

Analysis Note

These secondary standards offer multi-traceability to the USP, EP and BP 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.

Footnote

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.

Pictograms

Health hazard

Signal Word

Danger

Hazard Statements

Hazard Classifications

Repr. 1B - STOT RE 2

Storage Class Code

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

WGK Germany

WGK 2

Flash Point(F)

Not applicable

Flash Point(C)

Not applicable

Certificate of Analysis

Certificate of Origin

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)
Development and validation of a stability-indicating RP-HPLC method for assay of betamethasone and estimation of its related compounds
Fu Q, et al.
Journal of Pharmaceutical and Biomedical Analysis, 51(3), 617-625 (2010)
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)
Brian W Blakley et al.
The Laryngoscope, 124(5), 1209-1213 (2013-10-22)
To determine whether betamethasone (BM) reduces the cochlear toxicity of otic gentamicin (GM) if given together. Controlled animal study. Thirty-four mice were assigned at random to receive intratympanic injections of either 0.1 % BM (11 mice), 0.3% GM (13 mice)...

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