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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?

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