Testimonial by Dr. Jegan Jayabalan, Recipharm Pharmaservices Pvt Ltd, Bangalore (An Analytical excellence center for Recipharm group of companies) Senior Director of Analytical R&D.
Recipharm, a Contract Research Organization, conducts in vitro release testing (IVRT) using Teledyne Hanson's
Phoenix diffusion instrument, duly qualified to meet regulatory standards. Our expert team has developed an in-house IVRT method for topical formulations, involving rigorous steps such as receptor medium selection, sink condition evaluation, membrane selection, and mass balance studies. The release profile aligns with regulatory guidelines for semisolid dosage forms and was submitted to the USFDA, successfully defended during an audit.
Our experience with Teledyne Hanson's IVRT instrument has been exceptionally positive. Its user-friendly operation, accurate performance, and strong technical support have greatly enhanced our testing capabilities.
This instrument has empowered us to handle semisolid products in-house and enables us to compare in-vitro release testing of in-house samples with RLD samples for Bioequivalence purposes, complying with 21 CFR Part 11 requirements. This extends our analytical capacities to diverse formulations, allowing us to serve a broader spectrum of customer needs effectively.
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