Method Development and Validation

Advantar Laboratories provides cost efficient approaches to pharmaceutical development and validation services on large and small molecule active pharmaceutical ingredients (APIs), pharmaceutical intermediates and drug products.

Each project starts with a Protocol that defines the project objectives, scope, deliverables, timelines, experimental details and other parameters. We frequently assess whether or not a project is best undertaken with an initial feasibility study. For research or investigational studies, where the parameters are either unknown or not well defined, we can assign a fixed number of billable hours to address a given challenge. All work conducted is considered the clients' intellectual property (IP) and regularly-scheduled meetings provide the most current updates as to the overall progress and direction of the studies. Whether a method needs to be verified or validated for an intermediate, drug substance or drug product, Advantar can support your GLP or cGMP program needs.

Methods are developed and validated in accordance with either client-specific protocols or internal SOPs, and all methods are validated to meet FDA and/or ICH guidelines as follows:

• Specificity and selectivity
• Analyte Precision
• Intermediate Precision
• Linearity and Range
• Accuracy
• LOD / LOQ
• Ruggedness
• Standard and Sample Solution Stability
• Robustness (optional)