Y0001177
Dexamethasone for system suitability
European Pharmacopoeia (EP) Reference Standard
Synonym(s):
Dexamethasone, (11β,16α)-9-Fluoro-11,17,21-trihydroxy-16-methylpregna-1,4-diene-3,20-dione, 9α-Fluoro-16α-methyl-11β,17α,21-trihydroxy-1,4-pregnadiene-3,20-dione, 9α-Fluoro-16α-methylprednisolone, Prednisolone F
About This Item
Recommended Products
biological source
synthetic
grade
pharmaceutical primary standard
Agency
EP
API family
dexamethasone
form
powder
packaging
pkg of 10 mg
manufacturer/tradename
EDQM
storage condition
protect from light
mp
262-264 °C (lit.)
262-264 °C
solubility
water: <0.1 g/L
application(s)
pharmaceutical (small molecule)
format
neat
shipped in
ambient
storage temp.
2-8°C
SMILES string
C[C@@H]1C[C@H]2[C@@H]3CCC4=CC(=O)C=C[C@]4(C)[C@@]3(F)[C@@H](O)C[C@]2(C)[C@@]1(O)C(=O)CO
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+/m1/s1
InChI key
UREBDLICKHMUKA-CXSFZGCWSA-N
Gene Information
human ... NR3C1(2908)
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General description
This product is provided as delivered and specified by the issuing Pharmacopoeia. All information provided in support of this product, including SDS and any product information leaflets have been developed and issued under the Authority of the issuing Pharmacopoeia. For further information and support please go to the website of the issuing Pharmacopoeia.
Application
Biochem/physiol Actions
Packaging
Other Notes
related product
Signal Word
Danger
Hazard Statements
Precautionary Statements
Hazard Classifications
Repr. 1B
Storage Class Code
6.1C - Combustible, acute toxic Cat.3 / toxic compounds or compounds which causing chronic effects
WGK
WGK 3
Flash Point(F)
Not applicable
Flash Point(C)
Not applicable
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Protocols
A simple, precise and sensitive Reverse-Phase High Pressure Liquid Chromatography gradient method was adapted for traceability, homogeneity and total chromatographic analysis of Dexamethasone. The given experimental conditions follow the USP43-NF38 monograph method for Dexamethasone Assay and Organic Impurity Profiling. Dexamethasone, Betamethasone, Dexamethasone acetate and Desoximetasone were baseline resolved within 20 minutes using a Titan C18 UHPLC column (2.1 x 100 mm, 1.9 µm).
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