Orlistat Impurity 2

Comparison of impurity profiles of Orlistat pharmaceutical products using HPLC tandem mass spectrometry
A Schneider, L A Wessjohann
J Pharm Biomed Anal. 2010 Nov 2;53(3):767-72
 
Quantification of ssrr impurity of orlistat in orlistat capsules by normal phase hplc uv detector
Palakurthi Ashok Kumar*, Vinta Bhanu Prakash Reddy, Sivaranjani Thiyaharajan
international research journal of pharmacy 2012, 3 (4)
 
Development and Validation of an HPLC Method for Quantitative Determination of Seven Impurities in Orlistat Capsules and Characterization of Two Novel Impurities
Wenning Yang, Wei Peng, Yang Liu, Chengbo Hou, Zhiqiang Luo, Guopeng Wang, Mingmin Tang, Ruirui Yang, Hua Zhang, Jingjuan Wang
Current Pharmaceutical Analysis Volume 12 , Issue 3 , 2016
 
Stability Indicating RP-HPLC Method for the Estimation of ORLISTAT in Bulk and Pharmeceutical Dosage Forms
N.V. Venkataramana, Nivedita R Desai, Swamy Sreenivasa, D.B. Aruna Kumar
Eurasian Journal of Analytical Chemistry 2019 14 (2): 27-35

Orlistat Impurity 2 is chemically N-Formyl-L-leucine (3S,4S,6S)-3-Hexyltetrahydro-2-oxo-6-undecyl-2H-pyran-4-yl Ester. Orlistat Impurity 2 is supplied with detailed characterization data compliant with regulatory guideline. Orlistat Impurity 2 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 Orlistat .

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.