Chapter 2: Pharmacopoeias

Author: 

Dr Vijaykumar Darshanam,

HOD and Professor, Department of Pharmaceutics, Swami Vivekananda Institute of Pharmaceutical Sciences, Yadagirigutta, Yadadri Bhongir, Telangana, India

Abstract: Pharmacopoeias serve as authoritative compendia of standards for pharmaceutical substances, playing a crucial role in ensuring drug quality, safety, and efficacy. These official publications provide detailed specifications for the identity, purity, and quality of drugs and excipients. The concept of pharmacopoeias dates back to ancient medical texts, evolving into standardized references for modern pharmaceutical practice. Today, major pharmacopoeias such as the United States Pharmacopeia, British Pharmacopoeia, and European Pharmacopoeia are regularly updated to reflect advances in pharmaceutical science and technology. These compendia contain monographs detailing drug descriptions, identification tests, purity criteria, assay methods, and storage requirements. Pharmacopoeias also include general chapters on analytical methods, dosage form standards, and quality control procedures. The development and revision of pharmacopoeial standards involve collaborative efforts between regulatory bodies, industry experts, and academic researchers. Efforts towards international harmonization aim to streamline global pharmaceutical trade and ensure consistent drug quality worldwide. Understanding and applying pharmacopoeial standards is essential for pharmaceutical professionals in drug development, manufacturing, and quality assurance

Keywords:  Monograph, Drug standards, Quality control, Regulatory compliance, Harmonization, Pharmaceutical analysis

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