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PHR1526

Supelco

Dexamethasone

Pharmaceutical Secondary Standard; Certified Reference Material

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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
Empirical Formula (Hill Notation):
C22H29FO5
CAS Number:
50-02-2
Molecular Weight:
392.46
Beilstein:
2066651
EC Number:
200-003-9
MDL number:
MFCD00064136
UNSPSC Code:
41116107
PubChem Substance ID:
329823438
NACRES:
NA.24

biological source

synthetic

Quality Level

300

grade

certified reference material
pharmaceutical secondary standard

Agency

BP
EP
USP
traceable to BP 578
traceable to Ph. Eur. D0700000
traceable to USP 1176007

vapor pressure

<0.0000001 kPa ( 25 °C)

API family

dexamethasone

CofA

current certificate can be downloaded

packaging

pkg of 1 g

storage condition

protect from light

technique(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

application(s)

pharmaceutical (small molecule)

format

neat

shipped in

ambient

storage temp.

2-30°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 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

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.
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.

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.

Recommended products

Find a digital Reference Material for this product available on our online platform ChemisTwin® for NMR. You can use this digital equivalent on ChemisTwin® for your sample identity confirmation and compound quantification (with digital external standard). An NMR spectrum of this substance can be viewed and an online comparison against your sample can be performed with a few mouseclicks. Learn more here and start your free trial.

related product

Product No.
Description
Pricing

1177000

Dexamethasone phosphate, United States Pharmacopeia (USP) Reference Standard

D0710000

Dexamethasone acetate, European Pharmacopoeia (EP) Reference Standard

D0720000

Dexamethasone sodium phosphate, European Pharmacopoeia (EP) Reference Standard

D0700000

Dexamethasone, European Pharmacopoeia (EP) Reference Standard

D0718000

Dexamethasone pivalate, European Pharmacopoeia (EP) Reference Standard

Y0000511

Dexamethasone isonicotinate for impurity C identification, European Pharmacopoeia (EP) Reference Standard

Y0000538

Dexamethasone isonicotinate, European Pharmacopoeia (EP) Reference Standard

Y0001177

Dexamethasone for system suitability, European Pharmacopoeia (EP) Reference Standard

Y0001169

Dexamethasone acetate impurity E, European Pharmacopoeia (EP) Reference Standard

Y0001477

Dexamethasone sodium phosphate for peak identification, European Pharmacopoeia (EP) Reference Standard

Y0001593

Dexamethasone for peak identification, European Pharmacopoeia (EP) Reference Standard

1176506

Dexamethasone acetate, United States Pharmacopeia (USP) Reference Standard

1176007

Dexamethasone, United States Pharmacopeia (USP) Reference Standard

PHR1527

Dexamethasone Acetate, Pharmaceutical Secondary Standard; Certified Reference Material

BP578

Dexamethasone, British Pharmacopoeia (BP) Assay Standard

1177032

Dexamethasone sodium phosphate, United States Pharmacopeia (USP) Reference Standard

PHR1768

Dexamethasone Sodium Phosphate, Pharmaceutical Secondary Standard; Certified Reference Material

BP108

Dexamethasone sodium phosphate, British Pharmacopoeia (BP) Reference Standard

PHR1628

Dexamethasone Phosphate, Pharmaceutical Secondary Standard; Certified Reference Material

BP811

Dexamethasone impurity standard, British Pharmacopoeia (BP) Reference Standard

Pictograms

Health hazard
GHS08

Signal Word

Danger

Hazard Statements

H360FD

Hazard Classifications

Repr. 1B

WGK

WGK 3

Flash Point(F)

Not applicable

Flash Point(C)

Not applicable

Regulatory Information

监管及禁止进口产品

Certificates of Analysis (COA)

Search for Certificates of Analysis (COA) by entering the products Lot/Batch Number. Lot and Batch Numbers can be found on a product’s label following the words ‘Lot’ or ‘Batch’.

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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)
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
Lotfi Benboubker et al.
The New England journal of medicine, 371(10), 906-917 (2014-09-04)
The combination melphalan-prednisone-thalidomide (MPT) is considered a standard therapy for patients with myeloma who are ineligible for stem-cell transplantation. However, emerging data on the use of lenalidomide and low-dose dexamethasone warrant a prospective comparison of the two approaches. We randomly
Michael J White et al.
Cell, 159(7), 1549-1562 (2014-12-20)
Activated caspases are a hallmark of apoptosis induced by the intrinsic pathway, but they are dispensable for cell death and the apoptotic clearance of cells in vivo. This has led to the suggestion that caspases are activated not just to kill
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