Amiodarone Metabolite M11-5

N° de SZ CAT:	SZ-A007024
Número CAS	1547401-07-9
Mol.F.	C25H29I2NO4
Peso Molecular	661.3
Status de Fatura

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Nome Químico: (2-Butyl-6-hydroxybenzofuran-3-yl)(4-(2-(diethylamino)ethoxy)-3,5-diiodophenyl)methanone

Shipping Temperature: Ambient

HSN Code: 38229010

Country of Origin: India

Sorrisos: O=C(C(C=C1I)=CC(I)=C1OCCN(CC)CC)C(C(C2=C3)=CC=C3O)=C(O2)CCCC

Quality by design (QbD) based development and validation of an HPLC method for amiodarone hydrochloride and its impurities in the drug substance
S. Karmarkar ∗, X. Yang, R. Garber, A. Szajkovics, M. Koberda
Journal of Pharmaceutical and Biomedical Analysis 100 (2014) 167–174

Validation of a Stability-Indicating HPLC Method for the Determination of Amiodarone HCl and Its Related Substances in Amiodarone HCl Injection
Matthew J. Christopherson,* Kenton J. Yoder, and R. Brent Miller
Journal of liquid chromatography & related technologies vol. 27, No. 1, pp. 95–111, 2004

Stability-indicating HPLC method for determination of amiodarone hydrochloride and its impurities in tablets: a detailed forced degradation study
Ana Silva Coelho1 , Igor Felipe Rodrigues Ribeiro1 , Eduardo Burgarelli Lages
Braz. J. Pharm. Sci. vol.56

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 volume 61, pages599–607(2005)

Amiodarone Metabolite M11-5 is chemically (2-Butyl-6-hydroxybenzofuran-3-yl)(4-(2-(diethylamino)ethoxy)-3,5-diiodophenyl)methanone. Amiodarone Metabolite M11-5 is supplied with detailed characterization data compliant with regulatory guideline. Amiodarone Metabolite M11-5 can be used for the analytical method development, method validation (AMV), Quality Controlled (QC) application for Abbreviated New Drug Application (ANDA) or during commercial production of Amiodarone.

The product can be used as reference standards and further traceability against pharmacopeial standards (USP or EP) can be provided based on feasibility. SynZeal products are for analytical purpose only and not for human use.

Amiodarone Metabolite M11-5

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