February 6th, 2019 by Adam C. Fox
By Adam C. Fox, Senior Vice President, Analytical Operations, Nitto Avecia Pharma Services
Why is this service needed?
Improper detection and removal of residual solvents in raw materials and drug products can cause significant risks to quality and safety.
In many cases, solvents used to maximize production yields are difficult to eliminate. Too often, residual amounts of acetonitrile; chlorobenzene; 1,2-dimethoxyethane; and other powerful yet potentially harmful solvents remain in drug substances, excipients, and products.
U.S. Pharmacopeia (USP) Chapter <467> divides residual solvents into three classes based on toxicity. Class 1 solvents are to be avoided. They are either known or suspected human carcinogens. Class 2 solvents are effective yet potentially toxic. Class 3 solvents have low toxicity but are less effective as purification agents.
Traditional manufacturing techniques do not adequately remove most residual solvents.
What is the Nitto Avecia Pharma Services solution?
The company provides expert, rapid analysis, identification, and quantification of all three classes of residual solvents. Its USP-/ICH-compliant, state-of-the-art laboratory and experienced team of scientists allow clients to manage the many methods that may be involved in identification and quantification of impurities, including residual solvents.
How is Nitto Avecia Pharma Services different?
Detecting and managing residual solvents using gas chromatography (GC) is an organizational specialty. Nitto Avecia Pharma Services uses both GC and high-performance liquid chromatography (HPLC) to separate complex samples into their constituents. Additionally, over the years it has developed specific expertise and high capacity for utilizing GC technology for residual solvents.
Compared to other providers of its size, Nitto Avecia Pharma Services has a surprisingly large number of GC systems. This provides clients with high throughput processing and faster turnaround times. The company continually updates this infrastructure to meet advanced standards. And, it combines GC technology with sophisticated method development and validation techniques that give clients a competitive advantage.
This experience is especially important because product approvals and continued licensing depend on clear and conclusive method validation reports.
Nitto Avecia Pharma Services has detailed knowledge of residual solvent study designs that will meet agency expectations and it knows which protocols work best for specific samples. In many cases, clients have reported that final method validation reports provided by Nitto Avecia Pharma Services were the key factor in getting agency approval.
Why work with Nitto Avecia Pharma Services?
Nitto Avecia Pharma Services supports product quality and safety with unmatched speed, flexibility, high capacity, and highly developed expertise in detecting and quantifying residual solvents.
Posted in: Outsourced Pharma