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
• Empirical Formula (Hill Notation): C₂₂H₂₉FO₅
• CAS Number: 378-44-9
• Molecular Weight: 392.46
• EC Number: 206-825-4
• MDL number: MFCD00062969
• UNSPSC Code: 41116107
• PubChem Substance ID: 329823372
• NACRES: NA.24

Properties

• biological source: synthetic
• Quality Level: 300
• grade: certified reference material; pharmaceutical secondary standard
• Agency: BP; EP; USP; traceable to BP 575; 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)

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).[1] It exhibits anti-inflammatory activity[1] 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.[2]

Application

Betamethasone may be used as a pharmaceutical reference standard for the quantification of the analyte in pharmaceutical formulations[3][4] by using micellar liquid chromatography technique[3] and reversed-phase high-performance liquid chromatography technique.[4]

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 Information

• Pictograms: GHS08
• Signal Word: Danger
• Hazard Statements: H360FD,H373
• Precautionary Statements: P202 - P260 - P280 - P308 + P313 - P405 - P501
• 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