Y0001177

Dexamethasone for system suitability

European Pharmacopoeia (EP) Reference Standard

Synonym(s):
Dexamethasone, 9α-Fluoro-16α-methylprednisolone, 9α-Fluoro-16α-methyl-11β,17α,21-trihydroxy-1,4-pregnadiene-3,20-dione, Prednisolone F, (11β,16α)-9-Fluoro-11,17,21-trihydroxy-16-methylpregna-1,4-diene-3,20-dione
Empirical Formula (Hill Notation):
C22H29FO5
CAS Number:
Molecular Weight:
392.46
Beilstein/REAXYS Number:
2066651
MDL number:
PubChem Substance ID:
NACRES:
NA.24

biological source

synthetic

grade

pharmaceutical primary standard

Agency/Method

EP

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

Featured Industry

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

Dexamethasone belongs to the class of synthetic glucocorticoid steroid drugs.
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

Dexamethasone is used as a pharmaceutical primary standard to quantify the analyte in pharmaceutical formulations using liquid chromatography (LC) technique.

Biochem/physiol Actions

Glucocorticoid anti-inflammatory agent. Regulates T cell survival, growth, and differentiation. Inhibits the induction of nitric oxide synthase.

Packaging

Unit quantity: 10 mg. Subject to change. The product is delivered as supplied by the issuing Pharmacopoeia. For the current unit quantity, please visit the EDQM reference substance catalogue.

Caution

Other Notes

Sales restrictions may apply.

pictograms

Health hazard

signalword

Danger

hcodes

hazcat

Repr. 1B

storage_class_code

6.1C - Combustible, acute toxic Cat.3 / toxic compounds or compounds which causing chronic effects

WGK Germany

WGK 3

Flash Point F

Not applicable

Flash Point C

Not applicable

Certificate of Analysis

Certificate of Origin

Dexamethasone: Therapeutic Uses, Mechanism of Action and Potential Side Effects (2013)
Dexamethasone
European Pharmacopoeia Commission and European Directorate for the Quality of Medicines & Healthcare
European pharmacopoeia, 10(3), 4961-4963 (2021)
S Choi et al.
British journal of anaesthesia, 112(3), 427-439 (2014-01-15)
Brachial plexus nerve blocks (BPBs) have analgesic and opioid sparing benefits for upper extremity surgery. Single-injection techniques are limited by the pharmacological duration and therapeutic index of local anaesthetics (LAs). Continuous catheter techniques, while effective can present management challenges. Off-label...
Sara Bringhen et al.
Blood, 124(1), 63-69 (2014-05-24)
This multicenter, open-label phase 2 trial determined the safety and efficacy of carfilzomib, a novel and irreversible proteasome inhibitor, in combination with cyclophosphamide and dexamethasone (CCyd) in patients with newly diagnosed multiple myeloma (NDMM) ≥65 years of age or who...
A Keith Stewart et al.
The New England journal of medicine, 372(2), 142-152 (2014-12-09)
Lenalidomide plus dexamethasone is a reference treatment for relapsed multiple myeloma. The combination of the proteasome inhibitor carfilzomib with lenalidomide and dexamethasone has shown efficacy in a phase 1 and 2 study in relapsed multiple myeloma. We randomly assigned 792...
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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