In the Indian Pharmacopoeia (IP), quality control tests for tablets are essential to ensure their safety, efficacy, and quality. The key quality control tests typically include:


1. Identification Tests

  • Color Reaction Tests: To confirm the identity of the active pharmaceutical ingredients (APIs) by observing color changes with specific reagents.
  • Spectroscopy: Techniques like UV-Vis or IR spectroscopy to ascertain the chemical structure of the drug.

2. Physical Tests

  • Appearance: Assessment of the tablet's color, shape, and presence of any visible particles.
  • Size and Thickness: Measurement of dimensions to ensure uniformity and compliance with specifications.
  • Hardness: The resistance of a tablet to fracture or crumbling, usually measured using a hardness tester.
  • Friability: Testing the tablet's ability to withstand mechanical shocks during handling. A friability test measures the percentage weight loss of tablets subjected to a specified rotational speed.
  • Disintegration Time: Determining how quickly a tablet breaks down into smaller particles in a specified liquid medium.

3. Content Uniformity

  • Assay of Active Ingredients: Measuring the amount of the active pharmaceutical ingredient(s) in individual tablets to ensure they meet the labeled claim.

4. Dissolution Tests

  • Assessment of the rate and extent of drug release from the tablet in a specified dissolution medium. This is crucial for determining bioavailability.

5. Stability Testing

  • Evaluating how the quality of the tablets varies with time under the influence of environmental factors like temperature, humidity, and light.

6. Microbial Limit Tests

  • Ensuring that the tablets are free from harmful levels of microbial contamination. This is particularly important for non-sterile products.

7. Packaging and Labeling Compliance

  • Verification that packaging materials are suitable and labeling contains all necessary information as per regulatory requirements.

8. Chemical Stability Tests

  • Conducting tests to determine the degradation products and their impact on the effectiveness and safety of the tablets over time.

These tests help ensure that tablets produced conform to quality standards and regulatory requirements, ensuring the safety and efficacy of pharmaceutical products available in the market.