Related Experiment Video
Updated: Oct 1, 2026

A Package of Established Analytical Tools to Investigate the Solid-State Alteration of Lipid-Based Excipients
Published on: August 9, 2022
LC determination of diphemanil methylsulfate: application to stability study of stored pharmaceutical formulations
J J Houri1, G Gouaillard, V Acar
1Pharmacie Centrale des Hôpitaux de Paris, Agence Générale des Approvisionnements Médicaux, Service des Affaires Réglementaires, 7, rue du Fer à Moulin, 75005, Paris, France. jea-jacques.houri@pch.ap-hop-paris.fr
Abstract:
Diphemanil methylsulfate (DMS) is a synthetic antimuscarinic agent classically used in infants for vagal hypertonia-related symptoms. A normal-phase, isocratic liquid chromatographic method was developed for the quantitative determination of DMS in bulk drugs and in pharmaceutical forms. The method has been completely validated and robustness of this method has been studied. The limit of detection (LOD) for DMS impurities namely, impurity 1 and 2 were found to be 11 and 46 ng/ml. The limit of quantitation (LOQ) was found to be 49 and 139 ng/ml for impurity 1 and 2, respectively. The stability studies have been performed for 2 and 10 mg DMS tablets subjected at various temperatures: 25 degrees C (long term storage condition) and 40 degrees C (accelerated storage condition) for 18 and 6 months, respectively. At 25 degrees C, the samples were found to be stable for the study period. At 40 degrees C, 2 and 10 mg DMS tablets showed degradation up to 5 and 10% over a 6-month period.
More Related Videos
06:12Using Multiple Light Scattering to Examine the Stability of Phyllanthus emblica L. Extracts Obtained with Different Extraction Methods
Published on: April 14, 2023
06:23Preparation of DMMTAV and DMDTAV Using DMAV for Environmental Applications: Synthesis, Purification, and Confirmation
Published on: March 9, 2018
Related Concept Videos
Drug Product Stability
Pharmaceutical Alternatives: Stability-Related Therapeutic Nonequivalence
Factors Affecting Dissolution: Drug Permeability, Stability and Stereochemistry
Clinically Relevant Drug Product Specifications: Methods of Establishment
Factors Affecting Dissolution: Polymorphism, Amorphism and Pseudopolymorphism
Some polymorphic crystals possess lower aqueous solubility than their amorphous counterparts, leading to incomplete absorption. For instance, the oral suspension of Chloramphenicol, which...
Bioavailability Enhancement: Drug Stability Enhancement and GI Retention