Compendial Method Verification and Validation Studies

Pharmaceutical products often require the use of excipients and active pharmaceutical ingredients (APIs) that must be thoroughly tested and validated to ensure product quality, safety, and efficacy. Compendial methods, such as those specified in the United States Pharmacopeia (USP), European Pharmacopoeia (Ph. Eur.), or other relevant pharmacopoeias, provide standardized procedures for the analysis and testing of these materials.

At our laboratory, we offer comprehensive services for the verification and validation of compendial test methods for both excipients and APIs. Our team of experienced scientists and analysts work diligently to ensure that your testing programs meet all applicable regulatory requirements and guidelines.

Overview

Pharmacopeial method verification and validation studies involve a thorough evaluation of the performance characteristics of an analytical method to demonstrate that the method is suitable for its intended use.

This process typically involves the following.

Method Selection and Development - Selection or development of a suitable analytical method to meet compendial or regulatory requirements.
Method verification - A systematic experimental study of the selected method to evaluate its performance characteristics, such as accuracy, precision, specificity, linear range, detection limit, and quantification limit.
Method validity and applicability - To verify that the analytical method can reliably detect and quantify the desired analytes and can be applied to the analysis of real samples.
Validation of system suitability - To ensure that the entire analytical process (including sample collection, processing, and instrument operation) can produce reliable results.

Excipient testing

Excipients play a crucial role in the formulation and manufacture of pharmaceutical products, and it is essential to verify that they meet the specified quality attributes. Our excipient testing services include:

Compendial Method Verification: We perform a thorough evaluation of compendial test methods to ensure they are suitable for your specific excipient and can consistently produce accurate and reproducible results. This includes assessments of specificity, accuracy, precision, linearity, range, and robustness.
Method Validation: For non-compendial or novel excipient test methods, we can develop and fully validate the analytical procedures according to ICH Q2(R1) guidelines. This ensures the method is fit-for-purpose and can be reliably used for routine quality control or release testing.
Excipient Characterization: In addition to compendial testing, we can provide in-depth physical, chemical, and functional characterization of excipients to better understand their properties and behavior in formulations.

API testing

Ensuring the quality and purity of active pharmaceutical ingredients is paramount for the safety and efficacy of drug products. Our API testing services include:

Compendial Method Verification: We verify that compendial test methods, such as those specified in the USP or Ph. Eur., are suitable for your specific API and can consistently produce reliable results.
Method Validation: For non-compendial or custom API test methods, we can develop and fully validate the analytical procedures according to ICH Q2(R1) guidelines.
Impurity Profiling: In addition to compendial testing, we can perform in-depth impurity profiling and characterization to identify and quantify both known and unknown impurities in your API.

Our capabilities

Our state-of-the-art laboratory is equipped with a wide range of analytical instrumentation, including:

High-performance liquid chromatography (HPLC).
Gas chromatography (GC).
Liquid chromatography-mass spectrometry (LC-MS).
Fourier-transform infrared spectroscopy (FTIR).
X-ray powder diffraction (XRPD).
Thermal analysis (DSC, TGA).

Our team of skilled scientists and analysts have extensive experience in pharmaceutical testing and are committed to delivering high-quality results that meet the most stringent regulatory requirements.

Services