All about Pharmacopoeia

what is Pharmacopoeia

A. What is Pharmacopoeia (British spelling)/ Pharmacopeia (American spelling)?

A pharmacopoeia, pharmacopoea, or pharmacopeia is a regulatory requirement of a country that benchmarks standards and obligatory quality requirements for drugs, starting materials used to formulate drugs, and the different pharmaceutical formulations or preparations.

The book contains a test for the identification of the drug and raw materials. The government authority publishes the book. In some cases, it is published by medical or pharmaceutical society with government permission. The requirements of pharmacopoeia are mandatory for all formulators and distributors of drugs.

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Phar-ma-co-pe-ia was created from two Greek words: pharmakon means medicine, remedy, poison, or charm and poiein means to make or create.

what is Pharmacopoeia

The term Pharmacopoeia was observed initially as work published in Basel, Switzerland in 1561 by Doctor A. Foes. However, in the 17th century, it was utilized.

what is Pharmacopoeia

Up to the year 1617, the remedial medicines were provided by apothecaries. In this era, regulations on product quality and quantities were not enforced. In the early 16th century, work on medicines was published by various authorities in countries.

The Base document for the 1st British Pharmacopoeia (1864) was as follows:
i. Pharmacopoeia Londinensis (1618)
ii. Edinburgh Pharmacopoeia (1699)
iii. Dublin Pharmacopoeia (1807)

This was an outcome of The Medical Act that came into force in the year 1858. The act put stress on the harmonization of list compounds, medicines, and its preparations with accurate weight and measures.

2nd, 3rd, 4th, 5th, 6th, 7th, 8th, 9th, 10th, and 11th editions were made available in 1867 (addendum in 1874), 1885 (addendum in 1890), 1898, 1914, 1932, 1948, 1953, 1958, 1963 and 1968 respectively.

French Pharmacpoeia was available to use in 1818, and United States Pharmacopoeia was effective from the year 1820. On July 5, 1974, the combined publication form of USP an NF (national formulary was published).

In the year 1951, World Health Organization published Pharmacopoeia International with the objective of global uniformity of quality specifications for drugs, excipients, and dosage forms.

The first publication of Indian pharmacopoeia (IP) was made available in the year 1955 under the leadership of Dr. B. N. Ghosh.

B. What is Monographs?

The monograph in a pharmacopoeia is the compiled articles on drugs substance, other inactive starting materials, and dosage forms. The monograph contains quality expectations of materials such as description, tests to quantify potency and its limit, and details of other tests to meet the required standards.

The typical heading of the monograph are as follows:
1. Title
2. Chemical formulae
3. Atomic and molecular weight
5. Action and use
6. Definition
7. Characters: Appearance, Solubility
8. Identification
9. Assay
10. Impurities
11. Storage
12. Labeling

C. A list of pharmacopoeia, name, and years of first publication for different countries are given below:

CountryPharmacopeiaFirst published yearWebsite link
DenmarkEuropean Pharmacopoeia Pharmacopoea Nordica, Danish Edition1772http://www.sst.dk
Russian FederationState Pharmacopoeia of the Russian Federation, former title: State Pharmacopoeia of the Union of Soviet Socialist Republics)1778http://www.regmed.ru/
PolandFarmakopea Polska1817http://www.urpl.gov.pl/
United States of AmericaThe United States Pharmacopeia and National Formulary (USP-NF)1820https://www.usp.org/
MexicoFarmacopea de los Estados Unidos Mexicanos1846http://www.farmacopea.org.mx/
RomaniaPharmacopea Română1862http://www.anm.ro/en/home.html
United KingdomBritish Pharmacopoeia (BP)1864http://www.pharmacopoeia.com/
HungaryPharmacopoeia Hungarica)1871http://www.ogyi.hu/
GermanyDeutsches Arzneibuch (DAB)1872http://www.bfarm.de/DE/
Arzneimittel/2_zulassung/
verfahren/azBuch/20azBuchKomm/
20-10deutschAzBuchKomm/
dabKom-inhalt.html?
nn=1013988
ChileFarmacopora Chilena1882
JapanJapanese Pharmacopoeia (JP)1886http://www.pmda.go.jp/
english/rs-sb-std/
standards-development/jp/0009.html
ArgentinaFarmacopea Argentina1898http://www.anmat.gov.ar
BrazilBrazilian Pharmacopoeia (Farmacopéia Brasileira)1929http://novoportal.anvisa.gov.br/
LithuaniaLithuanian Pharmacopoea (Lietuvos Farmakopėja)1938http://www.vvkt.lt/
Czech RepublicCzech Pharmacopoeia1947http://www.sukl.eu/
pharmaceutical-industry/
informace-o-historii-
a-soucasnosti-ceskeho-lekopisu
InternationalInternational Pharmacopoeia (Ph. Int.)1951http://apps.who.int/phint/en/p/about/
ChinaPharmacopoeia of the People’s Republic of China1953http://wp.chp.org.cn
/en/index.html,
http://www.cmstp.com/
EgyptEgyptian Pharmacopoeia1953http://www.eda.mohp.gov.eg/
IndiaIndian Pharmacopoeia (IP)1955https://ipc.gov.in/mandates/
indian-pharmacopoeia.html
KoreaThe Korean Pharmacopoeia1958http://eng.mfds.go.kr/
EuropeEuropean Pharmacopoeia1967http://www.edqm.eu/, http://online.edqm.eu/entry.htm
Viet NamPharmacopoeia Vietnamica1970http://www.moh.gov.vn/homebyt/
en/portal/index.jsp
PakistanPakistan Pharmacopoeia1974http://www.dcomoh.gov.pk
/registration/
BrazilBrazilian Homeopathic Pharmacopoeia1976http://portal.anvisa.gov.br/
documents/33832/259147/
Farmacopeia+HOMEOPATICA+
3a+EDICAO+INGLES
+com+alerta.pdf/
49a48a50-0d3e-4a
b9-bc41-eb361c8afbb1
AfricaAfrican Pharmacopoeia1985http://au-strc.org/en/excdir.asp
ThailandThai Pharmacopoeia1987http://www.dmsc.moph.go.th
/webroot/drug
/eng/responsiblility.stm
SpainReal Farmacopea Española1996http://extranet.boe.es/index.php?
referer=/
farmacopea/index.php
Slovakia (Slovak Republlic)Codex Pharmaceuticus Slovacus MMVII1997http://sukl.sk/buxus/docs
/Posudzovanie_
kvality_liekov
/kodex2007.pdf
UkraineThe State Pharmacopoeia of Ukraine2001http://www.sphu.org
PhilippinesPhilippine Pharmacopeia2004http://www.doh.gov.ph
/bfad/orgchart.html
BelarusState Pharmacopoeia of the Republic of Belarus2006http://www.rceth.by/lffaeng.htm
CroatiaCroatian Pharmacopoeia2007http://www.halmed.hr/Lijekovi
/Farmakopeja
/Hrvatska-farmakopeja/
KazakhstanThe State Pharmacopoeia of the Republic of Kazakhstan (SPRK)2008http://www.dari.kz/
AustriaAustrian Pharmacopoeia2011http://www.bmg.gv.at
IranIranian Pharmacopoeia2013http://www.mohme.gov.ir/
EurasiaPharmacopoeia of the Eurasian Economic Union2018http://www.eurasiancommission.org
/ru/act/texnreg/
deptexreg/LS1/Pages/
pharmacopoeia.aspx

D. References:

https://www.who.int/medicines/areas/quality_safety/quality_assurance/resources/InternationalMeetingWorldPharmacopoeias_QAS13-512Rev1_25032013.pdf
https://qualitymatters.usp.org/

Index of world pharmacopoeias and pharmacopoeial authorities,
Working document QAS/11.453/Rev.10 January 2018 Original: English

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