Glycopyrrolate Impurity 1

Determination of the enantiomeric and diastereomeric impurities of RS-glycopyrrolate by capillary electrophoresis using sulfated--cyclodextrin as chiral selectors
Lihua Zuo1 Yunfeng Zhao1 Fenfen Ji2 Min Zhao1 Zhen Jiang1 Tiemin Sun3 ∗ Xingjie Guo
Electrophoresis 2014, 35, 3339–3344
 
In Vitro Characterization of the eFlow Closed System Nebulizer with Glycopyrrolate Inhalation Solution
Stephen Pham, Gary T. Ferguson, Edward Kerwin, Thomas Goodin, Alistair Wheeler, and Andrea Bauer
Journal of aerosol medicine and pulmonary drug delivery volume 31, number 3, 2018 pp. 162–169
 
Synchronous Estimation of Glycopyrrolate and Formoterol in Bulk and Pharmaceutical Dosage Form by RP-HPLC Method
Kishor Kumar Erukulla, Suseem Sundaram Rengitham
Indian Journal of Pharmaceutical Education and Research,  Vol 52, Issue 4 [Suppl], Oct-Dec, 2018

Glycopyrrolate Impurity 1 is chemically 3-Hydroxy-1,1-dimethylpyrrolidin-1-ium bromide. Glycopyrrolate Impurity 1 is supplied with detailed characterization data compliant with regulatory guideline. Glycopyrrolate Impurity 1 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 Glycopyrrolate.

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.