Analytical Method Development, Validation and Stability
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 developmentand/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.
Stability Program Management
Xcelience gathers information from our clients to establish the correct parameters of our Stability Studies, including appropriate test conditions, the duration of the stability study, the testing intervals, and the analytical methods. These processes vary with the type of product and type of study (scientific or regulatory). Xcelience has extensive experience at both.
Information is entered into our Stability Laboratory Information Management System (SLIM) – a state-of-the-art database designed specifically for stability operations. SLIM allows us to design a protocol specific to each client’s product needs. SLIM is a closed network that meets the FDA’s standards for 21 CFR Part 11 compliance. No unauthorized person can access SLIM to enter or alter information.
Xcelience has the capability to store stability samples at a variety of temperature and humidity conditions that meet the standards of the International Conference of Harmonization (ICH), including:
- 2° – 8° C
- 25° C/40% RH
- 25° C/60% RH
- 30° C/60% RH
- 30° C/65% RH
- 40° C/15% RH
- 40° C/75% RH
Xcelience stability chambers are fully validated, placed in secure areas, and continually monitored. The chambers are also equipped with alarms that notify staff when conditions move out of specification. This ensures that appropriate personnel are notified immediately so correct conditions can be restored within the time-frame required by our SOPs.
