PHR1398

Betamethasone

Pharmaceutical Secondary Standard; Certified Reference Material

• Sinónimos: 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
• Fórmula empírica (notación de Hill): C₂₂H₂₉FO₅
• Número de CAS: 378-44-9
• Peso molecular: 392.46
• Número CE: 206-825-4
• Número MDL: MFCD00062969
• Código UNSPSC: 41116107
• ID de la sustancia en PubChem: 329823372
• NACRES: NA.24

Propiedades

• origen biológico: synthetic
• Nivel de calidad: 300
• grado: certified reference material; pharmaceutical secondary standard
• Agency: BP; EP; USP; traceable to BP 575; traceable to Ph. Eur. B1000000; traceable to USP 1066009
• presión de vapor: <0.0000001 kPa ( 25 °C)
• familia API: betamethasone
• CofA: current certificate can be downloaded
• envase: pkg of 1 g
• condiciones de almacenamiento: protect from light (20 mm aluminium crimp seal for unused portion)
• técnicas: HPLC: suitable; gas chromatography (GC): suitable
• color: white to light yellow
• mp: 235-237 °C (lit.)
• solubilidad: acetone: sparingly soluble; chloroform: very slightly soluble; ethanol: sparingly soluble; ether: very slightly soluble; methanol: sparingly soluble; water: insoluble
• densidad: 0.305 g/cm³ at 25 °C (77°F)
• aplicaciones: pharmaceutical (small molecule)
• Formato: neat
• Condiciones de envío: ambient
• temp. de almacenamiento: 2-30°C
• cadena SMILES: [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
• Clave InChI: UREBDLICKHMUKA-DVTGEIKXSA-N
• Información sobre el gen: human ... NR3C1(2908)

Descripción

Descripción general

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]

Aplicación

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.

Nota de análisis

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

Otras notas

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.

Nota al pie de página

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.

Información de seguridad

• Pictogramas: GHS08
• Palabra de señalización: Danger
• Frases de peligro: H360FD,H373
• Consejos de prudencia: P202 - P260 - P280 - P308 + P313 - P405 - P501
• Clasificaciones de peligro: Repr. 1B - STOT RE 2
• Órganos de actuación: Liver,Kidney,Endocrine system
• Código de clase de almacenamiento: 6.1C - Combustible acute toxic Cat.3 / toxic compounds or compounds which causing chronic effects
• Clase de riesgo para el agua (WGK): WGK 2
• Punto de inflamabilidad (°F): Not applicable
• Punto de inflamabilidad (°C): Not applicable