Photolytic Degradation Photolytic degradation is a type of forced degradation that occurs when a drug molecule is exposed to light. The photolytic degradation process typically involves three steps: 1. Light Absorption: The first step in photolytic degradation is the absorption of light by the target molecule. Different molecules have varying abilities to absorb light…
Linearity earity is one of the key parameters assessed during method validation. It refers to the ability of an analytical method to produce results that are directly proportional to the concentration or amount of the analyte within a specific range When a method is linear, it means that the response of the measurement instrument…
Precision is one of the most important quality characteristics of an analytical method. It is a measure of how reproducible the results of the method are. Precision is important in method validation because it ensures that the method is producing consistent results. This is essential for ensuring the accuracy and reliability of the analytical…
Accuracy determines whether the product can be extracted using the solvent used in the test method. Assay: In drug manufacturing, it is crucial to accurately determine the concentration of the active pharmaceutical ingredient in the finished product. For example, if a tablet is claimed to contain 100 mg of a specific drug, the validated…
Test procedures for assessment of the quality levels of pharmaceutical products are subject to various requirements. According to Section 501 of the Federal Food, Drug, and Cosmetic Act, assays and specifications in monographs of the USP Pharmacopeia and the National Formulary constitute legal standards. The cGMP regulations [21 CFR 211.194(a)] require that…
Filtration can have significant effects on the results of analytical method validation, particularly in sample preparation and analysis processes. Filtration plays a role in method validation in several ways: Filtration study, the sample should be filtered through the proposed filter and the results should be compared with the unfiltered (centrifuged) sample. Acceptance…
Discovering straightforward tips for success in optimizing HPLC methods: 1. Use the appropriate column for your analytes and separation goals. 2. Optimize the mobile phase composition, including solvent type and concentration. 3. Adjust the pH of the mobile phase if necessary. 4. Optimize the flow rate to achieve optimal separation and resolution. 5. Use the…
1. Method Development This is the initial stage where the test method is developed based on the specific requirements of the pharmaceutical product. It involves determining the analytical technique, selecting appropriate instruments and reagents , and establishing the method parameters. 2. Method Validation Once the test method is developed, it needs to be validated…
