Limit Test for Quantitative Analysis

Limit tests of analytical procedures is important in demonstrating that a drug substance is suitable for a particular purpose. Limit test is nothing but to identify the impurities in the substance and compare it with standard. In general, limit test is defined as quantitative or semi quantitative test designed to identify and control small quantities of impurity which is likely to be present in the substance. Limit test is generally carried out to determine the inorganic impurities present in compound. Common Limit tests characteristics include: accuracy, precision (repeatability and intermediate precision), specificity, detection limit, quantitation limit, linearity, range, and robustness. In cases such as changes in synthesis of the drug substance, changes in composition of the finished product, and changes in the analytical procedure, revalidation is necessary to ensure quality control.

  • Stabilty of drug dosade form
  • Tests for arsenic
  • Tests for chloride
  • Quantitative determinations

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