Validation - Assay Method
At Bio-Concept, we are highly experienced in developing, qualifying, validating, and comprehensively documenting analytical methods for raw materials, process streams, dosage forms and cleaning operations. Our method development services cover a full range of analytical methodology including wet chemical, high-pressure liquid chromatography (HPLC), gas chromatography (GC). The analytical group employs state-of-the-art Water's Alliance 2690 HPLCs and routinely applies a photo-diode array detector for method development and validation.
For bulk drug and final dosage form, we develop stability-indicating assays and validate the method for active compounds and excipients. These procedures support finished product testing, stability studies, the analysis of batch residuals and cleaning agents.
Customized to your needs
Bio-Concept will customize a method
validation protocol to your specifications and to meet current ICH or USP/NF
requirements. Methods are validated for the following parameters:
- Accuracy
- Linearity
- Ruggedness (Intermediate Precision)
- Limit of Quantitation (LOQ)
- Limit of Detection (LOD)
- Precision
- Recovery
- Robustness
- Range
- Specificity
Our Method Development Guarantee
Bio-Concept is so sure of our process
for method development that we guarantee timely and successful completion of your
validated test method.