Pharmacopoeia, pharmacopeia, or pharmacopoea, (literally, "drug-making"), in its modern technical sense, is a book containing directions for the identification of samples and the preparation of compound medicines, and published by the authority of a government or a medical or pharmaceutical society. Descriptions of preparations are called monographs. In a broader sense it is a reference work for pharmaceutical drug specifications.
The word derives from Ancient Greek φαρμακοποιΐα (pharmakopoiia), from φαρμακο- (pharmako-) 'drug', followed by the verb-stem ποι- (poi-) 'make' and finally the abstract noun ending -ια (-ia). These three elements together can be rendered as 'drug-mak-ing'.
In early modern editions of Latin texts, the Greek spellings φ (f), κ (k) and οι (oi) are respectively written as ph, c, and oe, giving the spelling pharmacopoeia. In UK English, the letter oe is rendered as oe, giving us the spelling pharmacopoeia, while in American English oe becomes e, giving us the spelling pharmacopeia.
United States Pharmacopeia (USP)
The United States Pharmacopeia (USP) is the official pharmacopeia of the United States, published dually with the National Formulary as the USP-NF. The United States Pharmacopeial Convention (usually also called the USP) is the nonprofit organization that owns the trademark and copyright to the USP-NF and publishes it every year. Prescription and over–the–counter medicines and other health care products sold in the United States are required to follow the standards in the USP-NF. USP also sets standards for food ingredients and dietary supplements.
Indian Pharmacopoeia Commission (IPC)
Indian Pharmacopoeia Commission (IPC) is an autonomous institution of the Ministry of Health and Family Welfare which sets standards for all drugs that are manufactured, sold and consumed in India. The set of standards are published under the title Indian Pharmacopoeia (IP) which has been modelled over and historically follows from the British Pharmacopoeia. The standards that are in effect since December 1, 2010, is the Indian Pharmacopoeia 2010 (IP 2010). The Pharmacopoeia 2014 was released by Health Minister Ghulam Nabi Azad on
November 4, 2013. I.P., the abbreviation of 'Indian Pharmacopoeia' is familiar to the consumers in the Indian sub-continent as a mandatory drug name suffix. Drugs manufactured in India have to be labelled with the mandatory non-proprietary drug name with the suffix I.P. This is similar to the B.P. suffix for British Pharmacopoeia and the U.S.P. suffix for the United States Pharmacopeia. The IPC was formed according to the Indian Drugs and Cosmetics Act of 1940 and established by executive orders of the Government of India in 1945.
The International Pharmacopoeia
The aim of The International Pharmacopoeia (Ph. Int.), which is issued by the World Health Organization as a recommendation, is to achieve a wide global uniformity of quality specifications for selected pharmaceutical products, excipients, and dosage forms.
The information published in The International Pharmacopoeia is collated via a consultative procedure and is based on international experience, the monographs being established in an independent manner. Priority is given to medicines that are widely used throughout the world. High priority is accorded to medicines that are important to WHO health programs, and which may not appear in any other pharmacopoeias, e.g. new antimalarial drugs.
The European Pharmacopoeia
The European Pharmacopoeia (Ph. Eur.) of the Council of Europe is a pharmacopoeia, listing a wide range of active substances and excipients used to prepare pharmaceutical products in Europe. It includes more than 2000 specific and general monographs, including various chemical substances, antibiotics, biological substances; Vaccines for human or veterinary use; Immunosera; Radiopharmaceutical preparations; Herbal drugs; Homoeopathic preparations and homoeopathic stocks.
It also contains Dosage forms, General monographs, Materials and Containers, Sutures; 268 General methods with figures or chromatograms and 2210 reagents are described. The monographs give quality standards for all the main medicines used in Europe. All medicines sold in the 36 Member States of the European Pharmacopoeia must comply with these quality standards so that consumers have a guarantee for products obtained from pharmacies and other legal suppliers.
The European Pharmacopoeia is developed by the European Directorate for the Quality of Medicines (EDQM) and is a part of the Council of Europe, Strasbourg, France. It has been created by the Convention on the elaboration of a European Pharmacopoeia from 1964. Although the Pharmacopoeia is often listed as one of Council of Europe partial agreements, it is not, strictly speaking, a partial agreement. It has a different legal basis from the others, being
established as the result of a treaty. The others were established by a "statutory resolution" adopted by the Committee of Ministers. It is published by EDQM in English and French, official national translations are available in German and Spanish (Spanish version only online).
The Japanese Pharmacopoeia
The Japanese Pharmacopoeia (日 本 薬 局 方) is the official Pharmacopoeia of Japan. It is published by the Pharmaceuticals and Medical Devices Agency (独 立 行 政 法 人 医 薬 品 医 療 機 器 総 合 機 構) under the authority of the Ministry of Health, Labor and Welfare. The first edition was published on 25 June, 1886, with revisions being issued from time to time. The current revision is number 16, issued on 24 March 2011.
The Pharmacopoeia of the People's Republic of China (PPRC)
The Pharmacopoeia of the People's Republic of China (PPRC), compiled by the Pharmacopoeia Commission of the Ministry of Health of the People's Republic of China, is an official compendium of drugs, covering Traditional Chinese and western medicines, and giving information on the standards of purity, description, test, dosage, precaution, storage, and the strength for each drug. It is recognized by the World Health Organization as the official Chinese pharmacopoeia.
The 1997 English version consists of two volumes:
In the English edition, the 2005 version consists of 3 volumes (ISBN 7117069821). It is a "compendium of almost all traditional Chinese medicines and most western medicines and preparations. Information is given for each drug on standards of purity, description, test, dosage, precaution, storage and strength. Key features: A total of 2691 monographs: 992 for traditional Chinese medicines and 1699 for modern western drugs.
"Volume I contains monographs of Chinese material medica and pared slice, vegetable oil/fat and its extract, Chinese traditional patent medicines, single ingredient of Chinese crude drug preparations etc.; Volume II deals with monographs of chemical drugs, antibiotics, biochemical preparations, Radiopharmaceuticals and excipients for pharmaceutical use; Volume III contains biological products."
Click here to browse Pharmacopoeias
The word derives from Ancient Greek φαρμακοποιΐα (pharmakopoiia), from φαρμακο- (pharmako-) 'drug', followed by the verb-stem ποι- (poi-) 'make' and finally the abstract noun ending -ια (-ia). These three elements together can be rendered as 'drug-mak-ing'.
In early modern editions of Latin texts, the Greek spellings φ (f), κ (k) and οι (oi) are respectively written as ph, c, and oe, giving the spelling pharmacopoeia. In UK English, the letter oe is rendered as oe, giving us the spelling pharmacopoeia, while in American English oe becomes e, giving us the spelling pharmacopeia.
United States Pharmacopeia (USP)
The United States Pharmacopeia (USP) is the official pharmacopeia of the United States, published dually with the National Formulary as the USP-NF. The United States Pharmacopeial Convention (usually also called the USP) is the nonprofit organization that owns the trademark and copyright to the USP-NF and publishes it every year. Prescription and over–the–counter medicines and other health care products sold in the United States are required to follow the standards in the USP-NF. USP also sets standards for food ingredients and dietary supplements.
Indian Pharmacopoeia Commission (IPC)
Indian Pharmacopoeia Commission (IPC) is an autonomous institution of the Ministry of Health and Family Welfare which sets standards for all drugs that are manufactured, sold and consumed in India. The set of standards are published under the title Indian Pharmacopoeia (IP) which has been modelled over and historically follows from the British Pharmacopoeia. The standards that are in effect since December 1, 2010, is the Indian Pharmacopoeia 2010 (IP 2010). The Pharmacopoeia 2014 was released by Health Minister Ghulam Nabi Azad on
November 4, 2013. I.P., the abbreviation of 'Indian Pharmacopoeia' is familiar to the consumers in the Indian sub-continent as a mandatory drug name suffix. Drugs manufactured in India have to be labelled with the mandatory non-proprietary drug name with the suffix I.P. This is similar to the B.P. suffix for British Pharmacopoeia and the U.S.P. suffix for the United States Pharmacopeia. The IPC was formed according to the Indian Drugs and Cosmetics Act of 1940 and established by executive orders of the Government of India in 1945.
The International Pharmacopoeia
The aim of The International Pharmacopoeia (Ph. Int.), which is issued by the World Health Organization as a recommendation, is to achieve a wide global uniformity of quality specifications for selected pharmaceutical products, excipients, and dosage forms.
The information published in The International Pharmacopoeia is collated via a consultative procedure and is based on international experience, the monographs being established in an independent manner. Priority is given to medicines that are widely used throughout the world. High priority is accorded to medicines that are important to WHO health programs, and which may not appear in any other pharmacopoeias, e.g. new antimalarial drugs.
The European Pharmacopoeia
The European Pharmacopoeia (Ph. Eur.) of the Council of Europe is a pharmacopoeia, listing a wide range of active substances and excipients used to prepare pharmaceutical products in Europe. It includes more than 2000 specific and general monographs, including various chemical substances, antibiotics, biological substances; Vaccines for human or veterinary use; Immunosera; Radiopharmaceutical preparations; Herbal drugs; Homoeopathic preparations and homoeopathic stocks.
It also contains Dosage forms, General monographs, Materials and Containers, Sutures; 268 General methods with figures or chromatograms and 2210 reagents are described. The monographs give quality standards for all the main medicines used in Europe. All medicines sold in the 36 Member States of the European Pharmacopoeia must comply with these quality standards so that consumers have a guarantee for products obtained from pharmacies and other legal suppliers.
The European Pharmacopoeia is developed by the European Directorate for the Quality of Medicines (EDQM) and is a part of the Council of Europe, Strasbourg, France. It has been created by the Convention on the elaboration of a European Pharmacopoeia from 1964. Although the Pharmacopoeia is often listed as one of Council of Europe partial agreements, it is not, strictly speaking, a partial agreement. It has a different legal basis from the others, being
established as the result of a treaty. The others were established by a "statutory resolution" adopted by the Committee of Ministers. It is published by EDQM in English and French, official national translations are available in German and Spanish (Spanish version only online).
The Japanese Pharmacopoeia
The Japanese Pharmacopoeia (日 本 薬 局 方) is the official Pharmacopoeia of Japan. It is published by the Pharmaceuticals and Medical Devices Agency (独 立 行 政 法 人 医 薬 品 医 療 機 器 総 合 機 構) under the authority of the Ministry of Health, Labor and Welfare. The first edition was published on 25 June, 1886, with revisions being issued from time to time. The current revision is number 16, issued on 24 March 2011.
The Pharmacopoeia of the People's Republic of China (PPRC)
The Pharmacopoeia of the People's Republic of China (PPRC), compiled by the Pharmacopoeia Commission of the Ministry of Health of the People's Republic of China, is an official compendium of drugs, covering Traditional Chinese and western medicines, and giving information on the standards of purity, description, test, dosage, precaution, storage, and the strength for each drug. It is recognized by the World Health Organization as the official Chinese pharmacopoeia.
The 1997 English version consists of two volumes:
- Volume 1 (Herbal medicine), 1997, ISBN 7-5025-2062-7
- Volume 2 (Western medicine), 1997, ISBN 7-5025-2063-5
In the English edition, the 2005 version consists of 3 volumes (ISBN 7117069821). It is a "compendium of almost all traditional Chinese medicines and most western medicines and preparations. Information is given for each drug on standards of purity, description, test, dosage, precaution, storage and strength. Key features: A total of 2691 monographs: 992 for traditional Chinese medicines and 1699 for modern western drugs.
"Volume I contains monographs of Chinese material medica and pared slice, vegetable oil/fat and its extract, Chinese traditional patent medicines, single ingredient of Chinese crude drug preparations etc.; Volume II deals with monographs of chemical drugs, antibiotics, biochemical preparations, Radiopharmaceuticals and excipients for pharmaceutical use; Volume III contains biological products."
Click here to browse Pharmacopoeias