PHR1527

Supelco

Dexamethasone Acetate

Pharmaceutical Secondary Standard; Certified Reference Material

Synonym(s):
Dexamethasone 21-acetate, 9α-Fluoro-16α-methyl-11β,17α,21-trihydroxy-1,4-pregnadiene-3,20-dione-21-acetate, 9α-Fluoro-16α-methylprednisolone-21-acetate, Prednisolone F acetate
Empirical Formula (Hill Notation):
C24H31FO6
CAS Number:
Molecular Weight:
434.50
Beilstein/REAXYS Number:
2342608
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 (20 mm aluminium crimp seal for unused portion)

application(s)

HPLC: suitable
gas chromatography (GC): suitable

color

white

mp

460.4-464 °F (238—240°C)

solubility

acetone: freely soluble
dichloromethane: slightly soluble
methanol: freely soluble
water: practically insoluble

Featured Industry

Pharmaceutical (small molecule)

format

neat

pharmacopeia traceability

traceable to PhEur D0710000
traceable to USP 1176506

shipped in

ambient

SMILES string

[H][C@@]12CCC3=CC(=O)C=C[C@]3(C)[C@@]1(F)[C@@H](O)C[C@@]4(C)[C@@]2([H])C[C@@H](C)[C@]4(O)C(=O)COC(C)=O

InChI

1S/C24H31FO6/c1-13-9-18-17-6-5-15-10-16(27)7-8-21(15,3)23(17,25)19(28)11-22(18,4)24(13,30)20(29)12-31-14(2)26/h7-8,10,13,17-19,28,30H,5-6,9,11-12H2,1-4H3/t13-,17+,18+,19+,21+,22+,23+,24+/m1/s1

InChI key

AKUJBENLRBOFTD-RPRRAYFGSA-N

Gene Information

human ... NR3C1(2908)

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General description

Dexamethasone acetate (Decadron-LA) belongs to the class of long-acting glucocorticoids. 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.
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.
Dexamethasone Acetate is a steroid used for the treatment of various diseases because of its anti-inflammatory and inmunosuppresor effects. It is a common component of ointments, creams, lotions, aerosols and microemulsions.

Application

Dexamethasone Acetate may be used as a pharmaceutical reference standard for the determination of the analyte in pharmaceutical formulations by various chromatography techniques.
Dexamethasone acetate is used as a pharmaceutical reference standard for the quantification the analyte in pharmaceutical formulations using liquid chromatography (LC) 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.

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 LRAA3645 in the slot below. This is an example certificate only and may not be the lot that you receive.

Pictograms

Exclamation mark

Signal Word

Warning

Hazard Statements

Precautionary Statements

RIDADR

NONH for all modes of transport

WGK Germany

WGK 3

Flash Point(F)

Not applicable

Flash Point(C)

Not applicable

Certificate of Analysis
Certificate of Origin
Development and validation of HPLC method for analysis of dexamethasone acetate in microemulsions.
Urban MCC, et al.
Brazilian Journal of Pharmaceutical Sciences , 45(1), 87-92 (2009)
Determination of dexamethasone acetate in cream by HPLC.
Garcia CV, et al.
Journal of Pharmaceutical and Biomedical Analysis, 31(3), 597-600 (2003)
Daniele de Paula Faria et al.
Journal of nuclear medicine : official publication, Society of Nuclear Medicine, 55(8), 1330-1335 (2014-06-11)
The experimental autoimmune encephalomyelitis model is a model of multiple sclerosis that closely mimics the disease characteristics in humans. The main hallmarks of multiple sclerosis are neuroinflammation (microglia activation, monocyte invasion, and T-cell infiltration) and demyelination. PET imaging may be...
Dexamethasone
European Pharmacopoeia Commission and European Directorate for the Quality of Medicines & Healthcare
European pharmacopoeia, 10(3), 4961-4963 (2021)
Dunja Drakulić et al.
Journal of molecular neuroscience : MN, 55(4), 959-967 (2014-11-05)
Although dexamethasone (DEX), a synthetic glucocorticoid receptor (GR) analog with profound effects on energy metabolism, immune system, and hypothalamic-pituitary-adrenal axis, is widely used therapeutically, its impact on the brain is poorly understood. The aim of the present study was to...

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