Richman Chemical Inc. Newsletter
Method Development and Validation of Analytical Methods
for Drug Development
Issue XI | May 2017
FDA regulations require Investigational New Drug Applications (IND) that includes identity, strength, and purity data. Richman Chemical helps emerging technology, biotech, and pharmaceutical companies develop the necessary analytical methods to accurately identify new chemical entities via high performance liquid chromatography (HPLC), gas chromatography (GC), mass spectrometry (MS), infrared spectroscopy (IR), nuclear magnetic resonance spectroscopy (NMR), and particle size determination.
New analytical methods must be validated before they can be used under current Good Manufacturing Practices (cGMPs). Validation requires that the method perform acceptably for its intended use even while subjected to external stressors. Stressors include variations in temperature and sample concentration. In addition, proper identification of impurities via appropriate validated analytical methods is needed when identifying and quantifying the active component.
Richman Chemical aids many companies in achieving successful analytical method development and validation for critical IND filings and important clinical and commercial phases. To benefit from Richman Chemical’s thirty years of expertise, contact Christopher Kulp, Executive Vice President, at (215) 628-2946 ext 13 or via email at clk@richmanchemical.com. For more information regarding the custom services Richman Chemical has to offer, CLICK HERE.
Richman Chemical Inc.(RCI) was founded in 1988 and pioneered the independent outsourcing model. It is the only company in the market that provides its services throughout many markets including biotech, pharmaceutical and medical devices, specialty chemicals, nanotechnology, food and beverage, and flavor and fragrance.
Featured Products and Services
Featured Service: Customized Stability Studies
As part of a comprehensive CMC program offering, RCI offers ICH-compliant stability studies for both drug substance and drug product candidates. Click Here for more Information
Featured Unit Operations: Particle Size Reduction
For a sampling of the particle size reduction services we offer on lab to truck load scale from industrial to food GMP processing, Click Here.
Featured Product: 5-Sulfoisophthalic Salt, Sodium Salt
Also known as NaSIP, it is used in a wide range of polymer systems, particularly polyesters and nylons. It polymerizes into the polymer backbone giving permanence to its performance. The sulfonic functionality imparts anti-static properties, soil protection and cationic dyeability for premium fiber applications.