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PHR1771

Digoxin

Pharmaceutical Secondary Standard; Certified Reference Material

Synonym(s):

Digoxin, 12β-Hydroxydigitoxin

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About This Item

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
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Quality Level

300

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

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)

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.

Application

Digoxin may be used as a pharmaceutical reference standard for the determination of the analyte in pharmaceutical formulations and plasma samples 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.

Analysis Note

These secondary standards offer multi-traceability to the USP and EP 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.
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.

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pictograms

Skull and crossbonesHealth hazard
GHS06,GHS08

signalword

Danger

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

Regulatory Information

危险化学品

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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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High-performance liquid chromatographic analysis of digoxin formulations.
Desta B and McErlane KM
Journal of Pharmaceutical Sciences, 71(7), 777-780 (1982)
Selective and quantitative analysis of 4-hydroxybenzoate preservatives by microemulsion electrokinetic chromatography.
Mahuzier PE, et al.
Journal of Chromatography A, 924(1-2), 465-470 (2001)
Simultaneous determination of digoxin and digitoxin by micellar electrokinetic chromatography and application to drug formulations.
Tseng HH, et al.
Journal of Separation Science, 26(18), 1693-1698 (2003)
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Global Trade Item Number

SKUGTIN
PHR1771-300MG04061835080083