Risk-MaPP, ICH Q9, ASTM 2500 in Action: Project Advantages of Practical Quality Risk Management Approaches

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Understanding Quantitative, Qualitative, and Limit Tests in Pharmaceutical Quality Control

In pharmaceuticals, quantitative, qualitative, and limit tests refer to different approaches for analyzing drugs and their components: 1 . Quantitative Test: This determines the exact amount or concentration of a specific substance in a pharmaceutical product. It provides precise measurements, such as the amount of active pharmaceutical ingredient (API) or impurities present. For example, assays like High-Performance Liquid Chromatography (HPLC) are used to quantify substances. 2. Qualitative Test: This identifies the presence or absence of a particular substance but does not measure its amount. These tests confirm the identity of the compound, ensuring that the correct API is present. Techniques such as Infrared (IR) spectroscopy or Thin Layer Chromatography (TLC) can be used for qualitative analysis. 3. Limit Test: This is a type of semi-quantitative test used to check whether the concentration of a substance (like impurities) in a sample is within prescribed limits. It doesn’t prov...
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USFDA Inspection Types

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How to perform specificity during method validations?

  Specificity is one of the method validation parameter. Specificity defined by ICH Q2(R1), is as below, “Specificity is the ability to assess unequivocally the analyte in the presence of components which may be expected to be present.” So in the  context of specificity, the interested component must get explicitly assessed in presence of other sample components. To explain it further, let us take an example of a finished product such as tablets. Test solution of tablets consists of interested compounds (such as API and impurities) as well as the components which are of no interest (such as excipients). The excipients, though they are of no interest, one can’t completely remove them from test solution and hence it is important to assess their impact on quantification of analyte. Also, in case of assay analysis, the impurities will become the components of no interest and one must assess impurity interference while performing specificity. Let us understand how specificity is co...
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