Analytical Method Development & Validation
Analytical Method Development & Validation
Xcelience has been a leader in analytical method development for years. We have experience with a wide array of analytical methods, including the following:
- Assay and Related Substances
- Dosage Uniformity (Content uniformity, weight variation)
- Absence of Active
- ID (FTIR, HPLC)
- Dissolution Test Methods
- Moisture
- Microbial Limits
About our Analytical Method Development and Validation Capabilities
Methods may be developed for any instruments on the Equipment List.
Analytical method development is performed to fulfill specific client specifications. During the method development process, there are continual progress updates and communication between Xcelience and the client.
In addition to our custom tailored analytical method development services, we can also facilitate any formulation development and/or GMP manufacturing needs that may arise, so you get exactly what you need as quickly and efficiently as possible.
Analytical method Validation is protocol-driven and typically includes tests such as linearity, accuracy, precision, specificity, robustness, ruggedness, limit of detection (LOD), limit of quantitation (LOQ), and stability of analytical solutions.
Upon completion of a method validation, a report is written which summarizes the results of the validation and states if predetermined acceptance criteria are met by the analytical method. The report is approved by Xcelience Analytical and Quality Assurance personnel as well as by the client.
Method Qualification is also protocol-driven and can be any combination of the tests listed above, usually determined by the client.
