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PHR1164

Amiodarone hydrochloride

Pharmaceutical Secondary Standard; Certified Reference Material

Synonym(s):

(2-Butyl-3-benzofuranyl)[4-[2-(diethylamino)ethoxy]-3,5-diiodophenyl]methanone hydrochloride, 2-Butyl-3-benzofuranyl-4-[2-(diethylamino)ethoxy]-3,5-diiodophenyl ketone hydrochloride

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About This Item

Empirical Formula (Hill Notation):
C25H29I2NO3 · HCl
CAS Number:
19774-82-4
Molecular Weight:
681.77
EC Number:
243-293-2
MDL number:
MFCD00069204
UNSPSC Code:
41116107
PubChem Substance ID:
329823181
NACRES:
NA.24

Key Documents

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grade

certified reference material
pharmaceutical secondary standard

Quality Level

300

Agency

traceable to Ph. Eur. A0575000
traceable to USP 1027302

API family

amiodarone

CofA

current certificate can be downloaded

technique(s)

HPLC: suitable
gas chromatography (GC): suitable

application(s)

pharmaceutical (small molecule)

format

neat

storage temp.

2-8°C

SMILES string

C(=O)(C=1C=2C(OC1CCCC)=CC=CC2)C3=CC(I)=C(OCCN(CC)CC)C(I)=C3.Cl

InChI

1S/C25H29I2NO3.ClH/c1-4-7-11-22-23(18-10-8-9-12-21(18)31-22)24(29)17-15-19(26)25(20(27)16-17)30-14-13-28(5-2)6-3;/h8-10,12,15-16H,4-7,11,13-14H2,1-3H3;1H

InChI key

ITPDYQOUSLNIHG-UHFFFAOYSA-N

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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.
Amiodarone hydrochloride is an antiarrhythmic drug used for the treatment of ventricular and supraventricular tachycardia.

Application

Amiodarone hydrochloride may be used as a pharmaceutical reference standard for the determination of the analyte in pharmaceutical formulations by high performance liquid chromatography.
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

Non-selective ion channel blocker. Amiodarone induces an immediate influx of Ca2+ in Saccharomyces cerevisiae, followed by mitochondrial fragmentation and cell death.

Analysis Note

These secondary standards offer multi-traceability to the USP and EP (PhEur) 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 LRAC3555 in the slot below. This is an example certificate only and may not be the lot that you receive.
Values of analytes vary lot to lot.

Signal Word

Warning

Hazard Classifications

Aquatic Acute 1 - Aquatic Chronic 1 - Carc. 2 - Eye Irrit. 2 - Lact. - Repr. 2 - Skin Irrit. 2 - STOT SE 3

Target Organs

Respiratory system

Storage Class Code

11 - Combustible Solids

WGK

WGK 3

Flash Point(F)

Not applicable

Flash Point(C)

Not applicable

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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Minhui Wang et al.
Pharmacological reports : PR, 66(6), 1022-1030 (2014-12-03)
The antiarrhythmic potential of a novel multichannel blocker CPUY102122 (CY22) was investigated in the present study. The effect of CY22 on rapid delayed rectifier potassium channel current (IKr) was studied using whole-cell patch clamp techniques in Chinese Hamster Ovary cells
S Karmarkar et al.
Journal of pharmaceutical and biomedical analysis, 100, 167-174 (2014-08-30)
The USP monograph describes an HPLC method for seven impurities in the amiodarone drug substance using a L1 column, 4.6mm×150mm, 5μm packing (PF listed ODS2 GL-Science, Inertsil column) at 30°C with detection at 240nm. The standard contains 0.01mg/mL of amiodarone

Protocols

LC/MS/MS Analysis of Interacting Cardiac Drugs Digoxin, Quinidine, Amiodarone and Verapamil on Titan™ C18

LC/MS/MS Analysis of Interacting Cardiac Drugs Digoxin, Quinidine, Amiodarone and Verapamil on Titan™ C18

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