Citalopram EP Impurity C

Semi-preparative isolation and structural elucidation of an impurity in citalopram by LC/MS/MS
Bhanu Ramana,∗, Brajesh A. Sharmaa,b, Pradeep D. Ghugare b, Pravin P. Karmuse b, Ashok Kumar b
Journal of Pharmaceutical and Biomedical Analysis 50 (2009) 377–383
 
Isolation and characterization of degradation products of citalopram and process-related impurities using RP-HPLC
Ramisetti Nageswara Rao Ale Narasa Raju Ramaram Narsimha
J. Sep. Sci. 2008, 31, 1729 – 1738
 
Improved One-Pot Synthesis of Citalopram Diol and Its Conversion to Citalopram
Ravindra Vedantham, VNKV Prasada Raju Vetukuri, Ambaiah Boini, Mukkanti Khagga, and Rakeshwar Bandichhor
Org. Process Res. Dev. 2013, 17, 5, 798–805
 
Characterization of an unknown impurity in citalopram hydrobromide active pharmaceutical ingredient by semi-preparative isolation and lc-esi/msn and nmr
Saji Thomas,1 Ashutosh Agarwal,1 Raghavendra Desai Rao,2 and Chandra S. Mathela
Journal of Liquid Chromatography & Related Technologies, 36:1999–2012, 2013

Citalopram EP Impurity C is chemically (3RS)-6-Cyano-3-[3-(dimethylamino)propyl]-3-(4-fluorophenyl)isobenzofuran-1(3H)-one (as per EP) ; 3-(3-Dimethylaminopropyl)-3-(4-fluorophenyl)-6-cyano-1(3H)-isobenzofuranone (as per USP). It is also known as Citalopram USP Related Compound C. Citalopram EP Impurity C is supplied with detailed characterization data compliant with regulatory guideline. Citalopram EP Impurity C 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 Citalopram.

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.