Pharmacopeia (or pharmacopoeia) is a book or collection of official standards and guidelines for the preparation, quality control, and use of medicines and other healthcare products. These standards are established by national or international organisations such as the British Pharmacopoeia (BP) and the United States Pharmacopeia (USP), and are acknowledged as the gold standard for ensuring the quality and safety of medicinal substances and products. Pharmacists, physicians, manufacturers, and regulatory agencies often refer to pharmacopoeias to make sure that the medicines and healthcare products they use or produce meet the required quality standards and are safe and effective for patient use.
The British Pharmacopeia (BP) requires the Paracetamol content to be between 95.0% and 105.0% of the labeled amount.
The BP also specifies limits for impurities such as p-aminophenol, 4-chloroaniline, and 4-aminophenol. For example, the limit for p-aminophenol is not more than 0.001%.
The BP also specifies limits for impurities such as p-aminophenol, 4-chloroaniline, and 4-aminophenol. For example, the limit for p-aminophenol is not more than 0.001%.
by TheMedtionary April 03, 2023