Betamethasone
SIAL/PHR1398 - Pharmaceutical Secondary Standard; Certified Reference Material
Synonym: 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
CAS Number: 378-44-9
Empirical Formula (Hill Notation): C22H29FO5
Molecular Weight: 392.46
EC Number: 206-825-4
MDL Number: MFCD00062969
Linear Formula: C22H29FO5
Product Type: Chemical
| agency | BP |
| EP | |
| traceable to BP 575 | |
| traceable to Ph. Eur. B1000000 | |
| traceable to USP 1066009 | |
| USP | |
| application(s) | pharmaceutical (small molecule) |
| biological source | synthetic |
| CofA | current certificate can be downloaded |
| color | white to light yellow |
| density | 0.305 g/cm3 at 25 °C (77°F) |
| format | neat |
| grade | certified reference material |
| pharmaceutical secondary standard | |
| InChI | 1S/C22H29FO5/c1-12-8-16-1 |
| InChI key | UREBDLICKHMUKA-DVTGEIKXSA |
| mp | 235-237 °C (lit.) |
| packaging | pkg of 1 g |
| Quality Level | 300  |
| shipped in | ambient |
| SMILES string | [H][C@@]12C[C@H](C)[C@](O |
| solubility | acetone: sparingly soluble |
| chloroform: very slightly soluble | |
| ethanol: sparingly soluble | |
| ether: very slightly soluble | |
| methanol: sparingly soluble | |
| water: insoluble | |
| storage condition | protect from light (20 mm aluminium crimp seal for unused portion) |
| storage temp. | 2-30°C |
| technique(s) | gas chromatography (GC): suitable |
| HPLC: suitable | |
| vapor pressure | <0.0000001 kPa ( 25 °C) |
| Analysis Note: | These secondary standards offer multi-traceability to the USP, EP and BP primary standards, where they are available. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| Symbol |  GHS08 |
| Signal word | Danger |
| Hazard statements | H360FD - H373 |
| Precautionary statements | P202 - P260 - P280 - P308 + P313 - P405 - P501 |
| Hazard Codes | T |
| Risk Statements | 61-48/20/21 |
| Safety Statements | 53-45 |
| RIDADR | NONH for all modes of transport |
| WGK Germany | WGK 2 |
| Flash Point(F) | Not applicable |
| Flash Point(C) | Not applicable |
| mp | 235-237 °C (lit.) |
| Density | 0.305 g/cm3 at 25 °C (77°F) |
| Storage Temp. | 2-30°C |
| UNSPSC | 41116107 |