Chemical Tests and Assays (Raw Material and Finished Drug Product)

Identification

The identification of raw materials is crucial for maintaining the quality, safety, and efficacy of pharmaceutical products, ensuring that they meet regulatory standards and are safe for consumption. In Pharmetric Laboratory we perform chemical identification methods for raw materials to confirm the identity, purity, and quality of the substances used in the production of medications.

Infrared (IR) Spectroscopy: Identifies functional groups and molecular structure by measuring the absorption of infrared light.

Ultraviolet-Visible (UV-Vis) Spectroscopy: Measures the absorbance of UV and visible light to determine the concentration and purity of a substance.

High-Performance Liquid Chromatography (HPLC): Separation and identification by the retention time of the major peak of the Sample solution corresponds to that of the Standard solution.

Mass Spectrometry (MS): Used in conjunction with LC to identify compounds based on their mass-to-charge ratio and fragmentation patterns.

Assay

Potency testing is crucial in the pharmaceutical industry to ensure that medications contain the appropriate amount of active pharmaceutical ingredient (API) and thus will perform as intended.

Several analytical techniques are used to test the potency of medications, in Pharmetric Laboratory we perform potency tests by:

• High-Performance Liquid Chromatography (HPLC): With 6 instruments featuring VWD, DAD, Fluorescence, and Refractive Index detectors, multiple columns, we perform USP methods and in-house developed methods for separating, identifying, and quantifying components in all type of formulations.
• Mass Spectrometry (MS): coupled with LC is used for identifying and quantifying the API. MS provides high sensitivity and specificity by measuring the mass-to-charge ratio of ions.
• Ultraviolet-Visible (UV-Vis) Spectroscopy: Measures the absorbance of UV or visible light by the API in a sample. This method is suitable for APIs that absorb light in the UV or visible spectrum and can be used for quick potency testing.
• Titration: the classical quantitative chemical analysis method. Acid-base titrations, redox titrations, or complexometric titrations are used depending on the API's chemical properties.

Method Development and Validation

Analytical method development and validation are critical processes in the pharmaceutical industry and other fields where precise and accurate measurements are essential.

In Pharmetric Laboratory we perform Method development and Validation determinando:

1. System Suitability: Tests to ensure that the analytical system is working correctly before or during the analysis.
2. Specificity using reference standards, demonstrating the ability of the method to distinguish the analyte from other components in the sample.
3. Linearity to demonstrate the method’s ability to produce results that are directly proportional to the concentration of the analyte within a given range.
4. Accuracy to ensure the closeness of the test results to the true value or a standard reference value.
5. Precision by repeatability performing the test multiple times under the same operating conditions over a short interval of time.
6. Intermediate Precision performing the test within the same laboratory but under different conditions (different days, analysts, equipment).
7. Robustness performing the test with variations demonstrating the ability of the method to remain unaffected by small, deliberate variations in method parameters, providing an indication of its reliability during normal usage.
8. Forced degradation conducted by exposing the sample to different stress conditions such as heat, light, acid, base and oxidation, to ensure the method es capable to separate degradants from the API.