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PHR1398 Supelco

Betamethasone

Pharmaceutical Secondary Standard; Certified Reference Material

Synonym: 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, Betamethasone

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Properties

Related Categories A-B, Analytical Standards, Analytical/Chromatography, Pharmaceutical Secondary Standards, Pharmacopeia & Metrological Institutes Standards More...
Quality Level   300
biological source   synthetic
grade   certified reference material
  pharmaceutical secondary standard
Agency/Method   BP
  EP
  USP
vapor pressure   <0.0000001 kPa ( 25 °C)
form   neat
packaging   pkg of 1 g
storage condition   protect from light
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
storage temp.   room temp
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)

Description

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, 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.

Safety & Documentation

Safety Information

Symbol 
GHS08  GHS08
Signal word 
Danger
Hazard statements 
Precautionary statements 
RIDADR 
NONH for all modes of transport
WGK Germany 
WGK 2
Flash Point(F) 
Not applicable
Flash Point(C) 
Not applicable

Documents

Certificate of Analysis (COA)

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Protocols & Articles

Articles

HPLC Analysis of Glucocorticoids on Ascentis® C8

From our library of Articles, Sigma-Aldrich presents HPLC Analysis of Glucocorticoids on Ascentis® C8
Keywords: Chromatography, Clinical, High performance liquid chromatography, Hormones

Peer-Reviewed Papers
15

References

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