Details

1. Specificity:

Selectivity Assessment: Demonstrating the ability of the analytical method to accurately identify and quantify the analyte of interest in the presence of potential impurities or matrix components.

Forced Degradation Studies: Conducting studies to assess the method's ability to detect and quantify impurities and degradation products.

2. Precision:

Repeatability and Intermediate Precision: Evaluating the precision of the method through the assessment of repeatability within the same laboratory and intermediate precision across different laboratories and analysts.

System Suitability: Establishing criteria for system suitability tests to ensure consistent performance of the analytical system.

3. Accuracy:

Recovery Studies: Conducting recovery studies to assess the accuracy of the method by determining the percentage recovery of the analyte from a sample matrix.

Standard Reference Materials (SRM): Utilizing SRMs to validate accuracy by comparing results to known values.

4. Linearity:

Calibration Curve Construction: Establishing a linear relationship between the analyte concentration and the detector response over a specified range.

Correlation Coefficient (R2): Determining the correlation coefficient to demonstrate the linearity of the calibration curve.

5. Range:

Working Range Definition: Defining the range of concentrations over which the method is intended to be used.

Bracketing and Matrix Extensions: Assessing the robustness of the method by including bracketing samples and matrix extension studies.

6. Limit of Detection (LOD) and Limit of Quantitation (LOQ):

Signal-to-Noise Ratio: Determining LOD and LOQ based on signal-to-noise ratios, considering background noise in the absence of the analyte.

Low Concentration Standard: Analyzing low concentration standards to establish the LOQ.

7. Robustness:

Systematic Variation Assessment: Evaluating the method's robustness by intentionally varying critical parameters, such as pH, temperature, and flow rate.

Statistical Analysis: Applying statistical methods to assess the impact of parameter variations on method performance.

Regulatory Compliance:

USFDA, EMEA, and ICH Guidelines Adherence: Ensuring that the analytical method validation process aligns with the specific guidelines provided by regulatory authorities.

Documentation Excellence: Preparing thorough and compliant documentation to support regulatory submissions.

Conclusion:

Our analytical method validation services cover all seven parameters in accordance with USFDA, EMEA, and ICH guidelines, ensuring that pharmaceutical companies have robust, accurate, and compliant methods for analyzing their products. By employing rigorous validation protocols and staying abreast of evolving regulatory standards, we contribute to the quality and reliability of analytical methods in the pharmaceutical industry.

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