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
• UNSPSC Code: 41116107
• NACRES: NA.24
• PubChem Substance ID: 329823602
• EC Number: 244-068-1
• Beilstein/REAXYS Number: 77011
• MDL number: MFCD00003674

Properties

• Product Name: Digoxin, Pharmaceutical Secondary Standard; Certified Reference Material
• InChI key: LTMHDMANZUZIPE-PUGKRICDSA-N
• 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
• 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
• grade: certified reference material; pharmaceutical secondary standard
• agency: traceable to Ph. Eur. D1900000; traceable to USP 1200000
• API family: digoxin
• 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
• Quality Level: 300
• Gene Information: human ... ATP1A1(476), ATP1A2(477), ATP1A3(478), ATP1A4(480), ATP1B1(481), ATP1B2(482), ATP1B3(483), FXYD2(486)

Description

Analysis Note

These secondary standards offer multi-traceability to the USP and EP primary standards, where they are available.

Application

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

A cardiac glycoside, substrate for Pgp.

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.[4]

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.

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
• signalword: Danger
• hcodes: H300,H331,H373
• pcodes: P260 - P264 - P270 - P301 + P310 - P304 + P340 + P311 - P314
• Hazard Classifications: Acute Tox. 2 Oral - Acute Tox. 3 Inhalation - STOT RE 2
• Storage Class: 6.1A - Combustible acute toxic Cat. 1 and 2 / very toxic hazardous materials
• wgk: WGK 3