What are Pharmacopoeias and why they are needed?

What are Pharmacopoeias and why they are needed?

The role of a modern pharmacopoeia is to furnish quality specifications for active pharmaceutical ingredients (APIs), FPPs and general requirements. The existence of such specifications and requirements is necessary for the proper functioning or regulatory control of medicines production.

What does a pharmacopoeia contain?

A pharmacopoeia, pharmacopeia, or pharmacopoea (from the obsolete typography pharmacopœia, meaning “drug-making”), in its modern technical sense, is a book containing directions for the identification of compound medicines, and published by the authority of a government or a medical or pharmaceutical society.

What are the different types of pharmacopoeia?

List of Pharmacopoeia

• A. United States Pharmacopeia. Its INN system symbol is USP.
• B. British Pharmacopoeia. Its INN system symbol is BP.
• C. European Pharmacopoeia.
• D. International Pharmacopoeia.
• E. Japanese Pharmacopoeia. Its INN system symbol is JP.
• F. Indian Pharmacopoeia.
• G. Chinese Pharmacopoeia.
• H. Others Pharmacopoeia.

What are pharmacopoeial standards?

Pharmacopoeial standards help ensure the quality and safety of essential medicines by providing analytical methods and appropriate limits for testing and assessing the active pharmaceutical ingredients, excipients and finished products.

What is pharmacopoeial monograph?

Herbal monographs in national pharmacopoeias and other authoritative documents play an important role in the authentication of herbal materials. In this context, a monograph is a document that defines a botanical drug and provides information that allows for its proper identification.

What is the most used pharmacopoeia?

Depending on the country, one or several pharmacopoeia(s) may be used. The most commonly used ones (and their current editions as of May 2018) are the: European Pharmacopoeia (Ph. Eur. / EP) 9th Ed.

What are the pharmacopoeias that are widely used?

In addition to USP, there are three other large pharmacopeias in the world, the European Pharmacopoeia (EP), the British Pharmacopoeia (BP), and the Japanese Pharmacopoeia (JP), all of which share the goal of publishing and producing quality standards for pharmaceuticals.

What do you mean by pharmacopoeial monograph?

A pharmacopoeial monograph is a compiled data about Active Pharmaceutical Ingredients (API) or Products (APP) with its identification tests, assay method, impurity profile, test for impurity, solubility, etc.

What is pharmacopoeia Slideshare?

Pharmacopoeia: the word derives from the ancient Greek word pharmakon means drug & poeia- to make. It is a legally binding collection, prepared by a national or regional authority& contains list of medicinal substances, crude drug & formulas for making preparation from them.

What is the difference between a pharmacopeia and a monograph?

In a broader sense, pharmacopoeia is a reference work for pharmaceutical drug specifications. Descriptions of preparations are called monographs. A monograph is a paper on a single topic.