Limit Tests

• Limit tests is an analytical method used to determine whether the concentration of a specific impurity or substance in a pharmaceutical product is below a predefined acceptable limit.
• It ensures the quality, safety, and efficacy of the drug by controlling potentially harmful impurities.

Types of Limit Tests:

1. Qualitative Limit Tests:

   • Provide a pass/fail result, indicating whether the impurity or substance is below or above the specified limit.
   • Involves comparison with a reference standard, often using visual cues like color intensity or precipitate size.

2. Quantitative Limit Tests:

   • Measure the actual concentration of the impurity or substance in the sample.
   • Uses analytical techniques such as HPLC, GC, or AAS to accurately determine impurity levels.

Common Uses of Limit Test:

1. Heavy Metals:

   • Ensures that toxic heavy metals (e.g., lead, cadmium, mercury, arsenic) are below acceptable limits to prevent harm.

2. Residual Solvents:

   • Verifies that solvents used during synthesis or purification are within safe limits, as some solvents can be toxic or have undesirable effects.

3. Preservatives and Antioxidants:

   • Confirms that the concentrations of preservatives or antioxidants are within acceptable ranges to ensure product stability and prevent contamination.

4. Microbial Contaminants:

   • Assesses whether the microbial load is within safe limits to ensure the product’s safety and efficacy.

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