PHR1527

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: 1177-87-3
• Molecular Weight: 434.50
• Beilstein/REAXYS Number: 2342608
• EC Number: 214-646-8
• MDL number: MFCD00027407
• UNSPSC Code: 41116107
• PubChem Substance ID: 329823439
• NACRES: NA.24

Properties

• biological source: synthetic
• Quality Level: 300
• grade: certified reference material; pharmaceutical secondary standard
• agency: BP; EP; USP; traceable to Ph. Eur. D0710000; traceable to USP 1176506
• 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 (20 mm aluminium crimp seal for unused portion)
• technique(s): HPLC: suitable; gas chromatography (GC): suitable

Description

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.[1][2]

Application

Dexamethasone Acetate may be used as a pharmaceutical reference standard for the determination of the analyte in pharmaceutical formulations[1][2] 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.[3]

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.

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.

Safety Information

• pictograms: GHS08
• signalword: Danger
• hcodes: H360FD
• pcodes: P201 - P202 - P280 - P308 + P313 - P405 - P501
• Hazard Classifications: Repr. 1B
• Storage Class: 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