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
• 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

Properties

• grade: certified reference material; pharmaceutical secondary standard
• Quality Level: 300
• Agency: traceable to BP 532; 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

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.
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, EP (PhEur) 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.

Values of analytes vary lot to lot.

Footnote

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.

Safety Information

• Pictograms: GHS08,GHS07,GHS09
• Signal Word: Warning
• Hazard Statements: H315,H319,H335,H351,H361fd,H362,H410
• Precautionary Statements: P260 - P263 - P273 - P302 + P352 - P305 + P351 + P338 - P308 + P313
• 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