PHR1526

Supelco

Dexamethasone

Pharmaceutical Secondary Standard; Certified Reference Material

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
EC Number:
MDL number:
PubChem Substance ID:
NACRES:
NA.24

Quality Level

biological source

synthetic

grade

certified reference material
pharmaceutical secondary standard

Agency/Method

BP
EP
USP

vapor pressure

<0.0000001 kPa ( 25 °C)

CofA

current certificate can be downloaded

packaging

pkg of 1 g

storage condition

protect from light

application(s)

HPLC: suitable
gas chromatography (GC): suitable

color

white

mp

262-264 °C (lit.)

solubility

DMSO: soluble
acetone: sparingly soluble
chloroform: slightly soluble
dioxane: soluble
ethanol: sparingly soluble
ether: very slightly soluble
methanol: sparingly soluble
water: practically insoluble

Featured Industry

Pharmaceutical (small molecule)

format

neat

pharmacopeia traceability

traceable to BP 578
traceable to PhEur D0700000
traceable to USP 1176007

shipped in

ambient

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 is a corticosteroid medication, with anti-inflammatory activity. It is widely used for inflammatory ocular conditions and for the treatment of skin-allergic reactions.
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.

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.
Dexamethasone may be used as a pharmaceutical reference standard for the quantification of the analyte in pharmaceutical formulations using voltammentric techniques and reversed-phase high-performance liquid chromatography technique.

Biochem/physiol Actions

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

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 LRAC2894 in the slot below. This is an example certificate only and may not be the lot that you receive.

Pictograms

Health hazard

Signal Word

Danger

Hazard Statements

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

Simultaneous determination of dexamethasone and moxifloxacin in pharmaceutical formulations using stability indicating HPLC method
Razzaq NS, et al.
Arabian Journal of Chemistry, 10(3), 321-328 (2017)
Determination of prednisolone, dexamethasone and hydrocortisone in pharmaceutical formulations and biological fluid samples by voltammetric techniques using b-cyclodextrin modified carbon paste electrode
Balaji K, et al.
African Journal of Pharmacy and Pharmacology, 2(8), 157-166 (2008)
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...

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