PHR1771

Digoxin

Pharmaceutical Secondary Standard; Certified Reference Material

• Synonym(s): Digoxin, 12β-Hydroxydigitoxin
• Empirical Formula (Hill Notation): C₄₁H₆₄O₁₄
• CAS Number: 20830-75-5
• Molecular Weight: 780.94
• Beilstein: 77011
• EC Number: 244-068-1
• MDL number: MFCD00003674
• PubChem Substance ID: 329823602
• NACRES: NA.24

Properties

• grade: certified reference material; pharmaceutical secondary standard
• Quality Level: 300
• Agency: traceable to Ph. Eur. D1900000; traceable to USP 1200000
• CofA: current certificate can be downloaded
• packaging: pkg of 300 mg
• technique(s): HPLC: suitable; gas chromatography (GC): suitable
• application(s): pharmaceutical (small molecule)
• format: neat
• storage temp.: 2-30°C
• SMILES string: C[C@H]1O[C@H](C[C@H](O)[C@@H]1O)O[C@H]2[C@@H](O)C[C@@H](O[C@@H]2C)O[C@H]3[C@@H](O)C[C@@H](O[C@@H]3C)O[C@H]4CC[C@@]5(C)[C@H](CC[C@@H]6[C@@H]5C[C@@H](O)[C@]7(C)[C@H](CC[C@]67O)C8=CC(=O)OC8)C4
• InChI: 1S/C41H64O14/c1-19-36(47)28(42)15-34(50-19)54-38-21(3)52-35(17-30(38)44)55-37-20(2)51-33(16-29(37)43)53-24-8-10-39(4)23(13-24)6-7-26-27(39)14-31(45)40(5)25(9-11-41(26,40)48)22-12-32(46)49-18-22/h12,19-21,23-31,33-38,42-45,47-48H,6-11,13-18H2,1-5H3/t19-,20-,21-,23-,24+,25-,26-,27+,28+,29+,30+,31-,33+,34+,35+,36-,37-,38-,39+,40+,41+/m1/s1
• InChI key: LTMHDMANZUZIPE-PUGKRICDSA-N
• Gene Information: human ... ATP1A1(476) , ATP1A2(477) , ATP1A3(478) , ATP1A4(480) , ATP1B1(481) , ATP1B2(482) , ATP1B3(483) , FXYD2(486)

Description

General description

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.
Digoxin is one of the digitalis glycosides, extensively utilized for the treatment of congestive heart failure (CHF). It exhibits positive inotropic effects, antiarrhythmic as well as vasoconstrictor actions. It is reported that digoxin and other cardiac glycosides could play important role in the prevention and/or treatment of proliferative diseases like cancer.[1]

Application

Digoxin may be used as a pharmaceutical reference standard for the determination of the analyte in pharmaceutical formulations[2][3][4] and plasma samples[1] by various chromatography techniques.

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

A cardiac glycoside, substrate for Pgp, upregulates Pgp expression and down regulates SXR (Steroid Xenobiotic Receptor).

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 LRAA8515 in the Documents slot below. This is an example certificate only and may not be the lot that you receive.

Safety Information

• Pictograms: GHS06,GHS08
• Signal Word: Danger
• Hazard Statements: H300 - H331 - H373
• Precautionary Statements: P260 - P264 - P270 - P301 + P310 - P304 + P340 + P311 - P314
• Hazard Classifications: Acute Tox. 2 Oral - Acute Tox. 3 Inhalation - STOT RE 2
• Storage Class Code: 6.1A - Combustible, acute toxic Cat. 1 and 2 / very toxic hazardous materials
• WGK: WGK 3