Organic Impurity Test

Organic impurities are unintended organic compounds found in a product and can originate from various sources, including the manufacturing process, storage conditions, or other factors.

Sources of Organic Impurities

• Raw Materials

Sometimes, organic impurities are present in the raw materials themselves, including isomers and related compounds.

• Production Process

During the manufacturing process, organic impurities can be generated as by-products, intermediates, or through the use of organic catalysts.

• Storage and Usage

Prolonged storage or improper handling of the product can lead to the formation of organic impurities, such as oxides and decomposition products.

• Chemical Reactions

Interactions between the product, excipients, and packaging materials can also create organic impurities. This can involve common organic reactions like esterification and hydrolysis, which can occur under natural conditions.

The presence of organic impurities in a product can affect its safety and effectiveness. Therefore, it is crucial to test for and control these impurities.

The International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) has issued a guideline (Q3A(R2)) that provides guidance on the classification, identification, and other information related to organic impurities in drugs.

Services at Protheragen-ING

Sample Rough Analysis and Project Planning

We initiate the process by conducting a rough analysis, understanding the possible scope of the organic impurity in the sample and its source. Based on the rough analysis, we develop a project plan that outlines the methodologies, timeline, and cost estimation.

Sample Preparation and Analysis

We perform preprocessing of samples, which may include grinding, dissolving, filtration, or column purification in order to obtain more accurate measurement results.

Analysis

We employ various methods for organic impurity analysis, including mass spectrometry (e.g., ESI-MS and MALDI-TOF MS) and spectroscopic methods (e.g., UV, IR, and NMR). These techniques help in characterizing the structure and quantitative determination of organic impurities.

Report Submission

Following the analysis, our experts integrate the data and generate a comprehensive report. The report provides measurement values, structural characterizations, and quantitative findings related to organic impurities.

If you have inquiries or require further information, please contact us. Protheragen-ING is committed to ensuring product quality and safety.