VitiPure® Meglumine LEX
VitiPure® Meglumine LEX improves the solubility and bioavailability of APIs. Meglumine is a multi-talented functional excipient which is used as a counter-ion to form a salt with the API, or as a standard excipient to modify the pH to enhance the API solubility and stability. Traditionally, Meglumine is used as a counter-ion in contrast media. Applications include oral solid, and liquid formulations. And, widely used in sensitive formulations where low bioburden and low endotoxin grade is required.
Product Information
- Manufactured according to IPEC GMP
- Complies to EP and USP
- Low Endotoxin grade is suitable for sensitive applications
- Control of TAMC, TYMC, objectionable bacteria
- Control of elemental impurities per ICH Q3D, according to sensitive applications limits
- In depth analysis of individual nitrosamines and risk assessment
- Excellent solubility and bioavailability enhancement agent
- Alternative to sodium as counter-ion
- Meglumine
- Solublizers
- Neutralizer
VitiPure® Meglumine LEX is used as a counter-ion in contrast media, as a buffering agent, and solubility enhancer of mildly acidic APIs.
Marketed solid formulations with meglumine include APIs such as: Telmisartan, Hydrochlorothiazide, Repaglinide, Amlodipine besylate, Lansoprazole, Rosuvastatin calcium, Esomeprazole magnesium trihydrate, Amlodipine, Ezetimibe etc.
Marketed liquid sensitive formulations with meglumine include APIs such as: Gadopentetate dimeglumine, Gadoterate meglumine, Meloxicam, Gadoteric acid, Delafloxacin meglumine, Fosaprepitant dimeglumine etc.
Ph.Eur: Megluminum; USP: Meglumine
IPEC GMP Pharma Grade
India
Clariant India Limited; Telangana 502313, India
25kg with double PE bags as inner packaging and plastic drum as external packaging; Sample size 0.5kg
24 months
