Amiodarone-d4 HCl - CAS 1216715-80-8
Category: Labelled APIs
Molecular Formula:
Molecular Weight:
Labelled Amiodarone
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Related CAS:
19774-82-4 (unlabelled)
Solid powder
1. Differences in lercanidipine systemic exposure when administered according to labelling: in fasting state and 15 minutes before food intake
Covadonga Álvarez & Estrella Gómez & Marta Simón. Eur J Clin Pharmacol (2012) 68:1043–1047
LER enantiomers were extracted as follows. A sample containing 1,000 μlofplasma,50 μl of amiodarone HCl (Sigma, St. Louis, MO) solution (2.4 μg/ml) and 50 μl of orthophosphoric acid (50%, v/v; Merck KGaA) was loaded onto the extraction cartridges (Oasis HLB, Waters Corp, Milford, MA), which had been preconditioned sequentially using 2×1,000 μl of methanol (Merck KGaA) and 2×1,000 μl of water. The eluted samples were dried in evaporating capsules at 35°C, re-suspended in 1 ml of mobile phase and injected directly into the chromatographic system.
2. The importance of impurity analysis in pharmaceutical products: an integrated approach
Nafisur Rahman, Syed Najmul Hejaz Azmi, Hui-Fen Wu. Accred Qual Assur (2006) 11: 69–74
In what follows, we illustrate the application of Scheme 1 by using a specific example, amiodarone hydrochloride. Scheme 2 represents possible sources of impurity generation in the synthesis of this substance. Chromatographic and spectroscopic techniques will form the backbone of the tools used to determine the impurity information required. There are eight impurity substances related to amiodarone hydrochloride. Two impurities namely, (2-butyl benzofuran-3-yl) (4-hydroxy-3,5-diiodophenyl)methanone (impurityD) and (2-butyl benzofuran-3-yl)(4-hydroxyphenyl) methanone (impurity E) are commercially available. It has been suggested that (2-butyl benzofuran-3-yl)(4-hydroxy-3,5-diiodophenyl) methanone is the key intermediate for the synthesis of amiodarone hydrochloride which is condensed with N-(2-chloroethyl)-N,N-diethylamine HCl. The unreacted intermediate appears as impurity D in the final product of amiodarone HCl. During the synthesis of the key intermediate two more byproducts are formed which appear as impurity E and F. The impurity E and F may also condense with N-(2-chloroethyl)-N,N-diethylamine HCl to give impurity A and C. The authentic standards of impurity D and E are available. The other impurities are separated by preparative HPLC. These impurities such as D and E are identified by preparative HPLC on matching the retention timeswith the authentic samples. ImpuritiesA, C, and F are characterized on the basis of the FTIR, NMR, and ESImass spectrometry.Then the identified impurities are synthesized for using as standard for quantitative determination.
3. Validation of a Stability Indicating LC Method for Amiodarone HCL and Related Substances
M. A. Khan*, S. Kumar, J. Jayachandran, S. V. Vartak, A. Bhartiya, S. Sinha. Chromatographia 2005, 61, June (No. 11/12)
The above mentioned isocratic method for the analysis of Amiodarone HCl and its related substances in Amiodarone HCl active Pharmaceutical Ingredient (API) is found to be simple, rapid and sensitive. The method facilitates the separation of five of known related substances of Amiodarone HCl with a resolution of minimum 3.0. The method is completely evaluated for its linearity, precision, accuracy, robustness, limit of quantitation and detection and stability in the solution. Additionally the specificity is evaluated by forced degradation of the analyte, which shows that the method is stability indicating.
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