QUALITY TESTS FOR TABLETS-IN BRIEF

Quality control (QC) checks for tablets are crucial to ensure they meet regulatory standards, safety, efficacy, and consistency. These checks occur at various stages of manufacturing, including raw material testing, in-process checks, and final product testing. Here’s a breakdown of the key quality control checks for tablets:

1. Raw Material Testing

Before tablet manufacturing, the raw materials (active pharmaceutical ingredients (APIs) and excipients) undergo:

• Identification test – Confirms the correct material.
• Purity and potency test – Ensures the right concentration.
• Microbial limits – Checks for contamination.
• Moisture content – Prevents degradation.

2. In-Process Quality Control (IPQC) Checks

These tests occur during manufacturing to maintain consistency.

Granulation Stage

• Particle size distribution – Ensures uniform blending.
• Moisture content (Loss on Drying, LOD) – Prevents sticking or hardness issues.
• Flowability – Assures uniform filling of dies.

Compression Stage

• Weight variation – Ensures uniform dosage.
• Hardness test – Verifies tablet strength (typically 4-10 kg/cm2).
• Thickness – Ensures uniformity.
• Friability test – Checks resistance to chipping/breaking (acceptable loss ≤1%).
• Disintegration test – Ensures the tablet breaks down within the required time (typically ≤30 minutes for uncoated tablets).
• Content uniformity – Confirms consistent API distribution.

3. Final Product Testing

After manufacturing, tablets undergo the following QC checks:

• Appearance & Organoleptic Properties Color, shape, and texture should be uniform. No cracks, capping, or sticking.
• Weight Variation Ensures consistent mass.
• Hardness & Friability Tablets should be strong enough to withstand handling but not too hard for disintegration.
• Disintegration Time Uncoated tablets should disintegrate within 15–30 minutes. Coated tablets may take longer (up to 60 minutes for film-coated tablets).
• Dissolution Test Measures the rate and extent of drug release. Should meet pharmacopeial limits (e.g., USP, BP).
• Assay (Potency Test) Determines API content (should be within 90-110% of label claim).
• Related Substances Determines % of impurities, degradants
• Microbial Limit Test Ensures compliance with microbial contamination limits.
• Residual solvents % residual solvents being carried over in the final product
• Stability Testing Long-term and accelerated stability tests to check degradation over time.

QC tests for tablets must comply with:

• United States Pharmacopeia (USP)
• British Pharmacopoeia (BP)
• European Pharmacopoeia (Ph. Eur.)
• International Council for Harmonisation (ICH) Guidelines
• World Health Organization (WHO) Guidelines

By performing these quality control checks, pharmaceutical manufacturers ensure that tablets are safe, effective and compliant with regulatory requirements.