Definition and scope of pharmaceutical analysis

• Scope of pharmaceutical analysis is a specialized branch of analytical chemistry focused on the identification, quantification, and determination of the quality, safety, and efficacy of pharmaceutical products.
• It involves the application of various analytical techniques and methodologies to ensure that drugs and other pharmaceutical substances adhere to established standards and regulatory requirements.

Scope of Pharmaceutical Analysis:

1. Quality Control:

   • Ensures pharmaceutical products meet quality standards for purity, potency, stability, and uniformity.
   • Involves analysis of raw materials, in-process materials, finished products, and packaging.

2. Drug Development:

   • Supports the identification and characterization of APIs and excipients.
   • Aids in optimizing formulations and manufacturing processes.

3. Method Development and Validation:

   • Focuses on creating, optimizing, and validating analytical methods to ensure accuracy, precision, and reliability.

4. Pharmacokinetics and Bioanalysis:

   • Analyzes drug ADME (absorption, distribution, metabolism, excretion) to guide dosing and understand pharmacological effects.

5. Stability Testing:

   • Evaluates drug stability under various conditions to determine shelf life and proper storage.

6. Impurity Profiling:

   • Identifies and quantifies impurities to ensure drug safety and efficacy.

7. Regulatory Compliance:

   • Ensures adherence to regulations and guidelines from authorities like the FDA and EMA.

8. Counterfeit Drug Detection:

   • Identifies counterfeit or adulterated drugs to safeguard public health and maintain the pharmaceutical supply chain.

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