The role of analytical chemistry in pharmaceutical industries is crucial because it ensures that drugs are safe, effective, and high quality. Here’s a breakdown:
1. Quality Control (QC)
- Checks if the drug meets required standards.
- Measures purity, concentration, and composition.
- Example: Ensuring that a tablet contains exactly 500 mg of paracetamol.
2. Drug Development
- Helps in formulating new drugs.
- Determines stability, solubility, and chemical structure of drug candidates.
- Example: Using spectroscopy to study the structure of a new molecule.
3. Detection of Impurities
- Identifies contaminants or degradation products.
- Ensures safety before the drug reaches patients.
- Example: Using HPLC to detect trace amounts of unwanted chemicals.
4. Dosage Form Analysis
- Checks the uniformity and release rate of drugs in tablets, capsules, or injections.
- Ensures proper therapeutic effect.
- Example: Measuring how fast a sustained-release tablet dissolves.
5. Regulatory Compliance
- Provides documentation and data for regulatory authorities.
- Ensures that drugs meet national and international standards (like FDA or WHO).
6. Stability Studies
- Determines how temperature, humidity, and light affect drugs.
- Helps in deciding shelf life and storage conditions.
In short: Analytical chemistry ensures that every drug is safe, effective, and consistent, from development to production to storage.