In the pharmaceutical industry, water analysis by coulometric titration with oven technique is widely used for determining the water content in pharmaceutical substances, products, and excipients. Water is a critical impurity in pharmaceutical products; it heavily affects the stability, efficacy, and quality of drugs. This technique utilizes the principle of coulometric titration, which involves the generation and measurement of electric charge to determine the amount of water present in a sample.
Water content in drug products can be measured using different analytical techniques, such as loss on drying, Karl Fischer titration, and thermogravimetric analysis.
The first step of the process begins with sample preparation, where a representative sample is accurately weighed and placed in a sample cell. The sample cell is then introduced into an oven specifically designed for moisture determination.
The United States Pharmacopeia (USP) has established guidelines for water analysis by coulometric titration with an oven mentioned in the USP General Chapter <921> “Water Determination” and Method Ic with the range of 50 C to 250 C. It covers various techniques, including Karl Fischer titration, loss on drying, and distillation. In the General Chapter <41> “Balances”, the USP parameters specifically emphasize the importance of instrument calibration. These guidelines ensure the accuracy and reliability of their water analysis results.

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Our wide range of analytical testing methods ensures quality control and reliability for each product. Our Coulometric Titration water analysis tests are a testament to the quality and purity of drug products, done with compliance with the regulatory requirements.

Importance Of Water Analysis By Coulometric Titration With Oven

The importance of this technique can be summarized in a few points:

  • Water often affects the efficacy of drugs. By accurately measuring and controlling water content, manufacturers can ensure the consistent quality and stability of their products.
  • Water Analysis by Coulometric Titration is faster and more efficient than traditional Karl Fischer titration methods.
  • Reliable and accurate water analysis results obtained through coulometric titration with an oven contribute to robust quality control processes and help ensure consistent product quality.

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