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Pharmacopoeia and Sources of Impurities in Medicinal Agents

Pharmacopoeia, Classification of pharmacopoeia, Indian Pharmacopoeia, British Pharmacopoeia, United States pharmacopeia, Impurities in medical agents.
The name pharmacopeia comes from the Greek words 'Pharmakon' meaning drug and 'Poiea' meaning to make. Governments across the world typically appoint recognized authorities who prepare official legal documents. In addition to pharmaceutical substances and formulae, standards and descriptions also comprise the list.

These are the types of pharmacopeias in a list
It includes Argentina, Austria, Belgium, Brazil, British, Chinese, Egyptian, European, French, German, Hungarian, Indian, Italian, Japanese, Yugoslavian, Mexican, Netherlands, Polish, Portuguese, Rumanian, Russian, Spanish, Turkish, United States.

Classification of pharmacopoeia
Compendiums of information about drugs are categorized as follows:

In addition to official compendia, there are non-official compendia
1. Official compendia
A drug and other related substance compilation that is recognized as a legal standard of purity, quality, and strength by government agencies in the countries where the substances originate.

2. Non- official compendia
A non-official drug compendium is a book that is not an official drug compendium and is used as a secondary reference source for researching drugs and other substances. These include Merck Index, Extra Pharmacopoeia (Martindale), and the United States Dispensatory.

Indian Pharmacopoeia
Edward John Waring was the first to edit the first officially approved IP in 1868. The Indian pre-independence era was when BP was used. It was published in 1900 as an edition by the Government of India. As part of the Indian Pharmacopeial listpublished in 1946, the Indian Government published a list of medicines. Sir R. N. Chopra headed a committee that compiled the Indian Pharmacopeial List under his leadership. Government of India, Government of Delhi, prepared the report in 1946. During the 1948 civil rights movement in India, a committee was appointed to draft the Indian Pharmacopeia. Members of that committee served for 05 years. The Indian Pharmacopeia committee, headed by B. N. Ghosh, published its first edition in 1955. Patents are written in English & titles of monographs are presented in Latin in the first edition. 986 monographs are covered in this volume. The 1960 supplement was published with this edition.

Dr. B. Mukherjee was the chairman of the IP commission that released the second edition of IP in 1966. There were 274 monographs in IP 55, plus their supplements, that were deleted. The addition of 93 new monographs has been completed. In English, monographs are titled according to their official titles. Metric units were used to express doses. "USUAL STRENGTH" has been prescribed for tablets and injections. In addition to the monograph of drugs, the formulations of the drugs were provided immediately.

In 1975, a supplement was published for this edition. In addition to 126 new monographs, 250 monographs have been amended. The vaccine for cholera was withdrawn. Among IP's 02 volumes & 09 appendices, the third edition appeared in 1985. The collection now includes 261 new monographs. A total of 450 monographs have been removed.

Addendum I - Editorial additions and amendments consist of 46 new monographs and 126 amendments to the 1989 version.

Addendum II - As part of Update II, 62 new monographs were added in 1991 and 110 amendments were made.

Dr. Nityanand was the editor-in-chief of the fourth edition of IP, published in 1996. In this edition, 1149 monographs and 123 appendixes were included. 294 new monographs are included in the publication & 110 are deleted.

Addendum I - This addendum contains 42 new monographs, which are applicable from the 31st December 2000.

Addendum II - The addition of 19 new monographs is effective from 30th June 2003.

208 individual monographs and four appendices comprise the veterinary supplement of IP 1996. A new edition of IP was published in 2008 with an addendum that made it the 5th edition. There are 3 volumes in IP 2007. General Notices and General Chapters are included in Volume 1.

Volumes 2 & 3 contain general monographs on pharmaceutical aids, dosage forms, and drug substances. Indian Pharmacopeia Commission (IPC), Ghaziabad has published the 6th edition of IP for 2010. From 1st September 2010, this edition will be in effect.

There are three volumes in the Indian Pharmacopoeia 2010.

vol. I of the Patent consists of three parts, namely, notices, preface, description of the IPC, acknowledgments, introduction, and general chapters.

As part of Volume II, you'll discover the General Notice, the General Monograph on Dosage Forms, and the General Monograph on Drug Substances, Dosage Forms, and Pharmaceutical Aids (A-M).

Monographs on drug substance, dosage form, and pharmaceutical aid (N to Z) are included in Volume III.

The veterinary products sector offers a wide range of products such as vaccines, immunosera, blood products, and biotechnology products.

Veterinary vaccines, antiretroviral drugs, and formulas indigenous to different parts of the world, as well as fixed-dose combinations and alternative antiretroviral drugs are all offered by the pharmaceutical industry. In this round of monograph publication, the number of extracts, anticancer drugs, herbal products, and antiretroviral drugs has increased. As the latest technology in the field develops, vaccines and immunosera's manuals are updated as well. An introduction on liposomal medicine and a monograph of liposomal Amphotericin B injection is important to include considering the latest advances in drug delivery technology. In the Appendices, there is an introduction to NMR spectroscopy. A great deal of effort has also gone into updating the chapter on microbial contamination to keep pace with prevailing international standards.

7th edition of IP 2014
A-Z monographs on 313 new drug substances, dosage forms, and pharmaceutical aids are now available from A-Z There are 43 new drug substance monographs. There are ten antibiotic monographs including Monographs on 31 herbs. The human use of vaccines and immunosera – 05 is also included. In addition to the 19 new chapters, there are six about Insulin products, seven about biotechnology products, etc. A new radiopharmaceutical monograph is included in this edition for the first time, in addition to a general chapter.

8th edition of IP 2018
  1. It has almost 4 Volumes in total.
  2. It also contains 170 Chemical Monographs in the 8th edition
  3. There are 15 herbal monographs made available
  4. In addition to it, 10 monographs on blood and related products are also mentioned
  5. 6 monographs on biotechnology-derived products are included
  6. Along with this, there are 2 monographs on the vaccine and immune sera
  7. With this, 3 monographs of radiopharmaceuticals are also added
  8. At last, there are 14 monographs of veterinary non-biologicals
British Pharmacopoeia
  • BP was first published in 1864 and is made up of two sections.
  • MateriaMedica, Part I
  • Preparation & Compounds, Part II
  • In 1867, BP published its second edition
  • 1885 was the year when the third edition was published of BP
  • BP was published in a fourth edition in 1898
  • An edition of BP published in 1914 was the fifth edition
Annually, it has been published. In BP 2007 material used specifically for preparing Traditional Chinese Medicines was described in monographs. There have been several changes to monographs, such as the replacement of the term "Prolonged release" with "Slow delivery", and the substitution of the term "Gastro-resistant" with "Enteric coated". The BP 2008 includes nearly 3100 monographs covering prescription drugs, preparations, and articles. Since January 1st, 2008, it has become effective. Volume 1, Volume 2, Volume 3, etc. have been published for BP 2007-2009.

Volumes I and II: Contain Medicinal substances.

Included in Volume III are prepared preparations, formulated products, blood products, immunological products. Along with this, radiopharmaceutical products, surgical materials, and homeopathic preparations are also added.

Supplemental chapters are available in Volume IV, along with IR spectra.

Veterinary products are included in Volume V.

CD-ROM version is in Volume VI.

BP 2010
As part of the Medicines and Healthcare Products Regulatory Agency (MHRA), the BP Secretariat sponsored the publication of BP, 2010 by the Stationery Office. The British Pharmaceutical Industry Standards (BP) are the official standards for medicinal products and pharmaceuticals. BP contains pharmaceutical substance monographs, formulation monographs, and other documents used in medical practice annually. As of January 1, 2010, the BP 2010 standards in the UK became legally binding.

For over 150 years, BP has been supplying pharmaceutical substances and medicinal products with authoritative, official standards. This text is used in almost 100 countries worldwide and is an essential resource for all researchers, manufacturers, and testers working in the pharmaceutical industry. As of 2010, BP 2010 contains 40 monographs covering formulated preparations. In addition, there are additionally prescribed standards for popular non-licensed formulations throughout the world. There is integrated into BP 2010 the entire content of the European Pharmacopoeia sixth edition, including Supplement 6.5. As a part of its work in the fields of herbal and complementary medicine, BP provides additional new and revised monographs for homeopathic stock preparations and mother tinctures. There are four volumes of BP 2010 in the print edition and one volume of BP (Veterinary).

BP 2013
In the package for BP 2013, you will find:

The BP (Veterinary) 2013 is included in the 06 volume printed edition. The BP monograph library has grown to 41 volumes. Added 40 new monographs to the European Pharmacopeia. The 619 monographs have been amended. One IR reference spectrum has been amended and 6 new ones have been added.

BP 2014
A total of almost 3500 monographs are included in the 2014 edition, and the Human Medicines Regulations of 2012 require them to be legally enforced. Volumes BP 2014 and BP (Veterinary) are both included in Volume 2014. You also receive a fully searchable CDROM as well as an online access option, providing you with a variety of flexible resources. From January 1, 2014, it is legally binding. In the BP (Vet) Monographs series there are 40 new monographs and 272 amendments. The new supplementary chapters consist of 03 chapters. Chapter 01 of the new BP (Vet) Supplement.

BP 2018
Thirty-five newly published monographs. The BP monographs have been amended 185 times. Monographs for four new unlicensed formulations are available. A new monograph for each of the herbal medicines, Veterinary medicine monographs for 06 new products.

United States pharmacopeia
First published in Latin and English on 15th December 1820, the first edition of USP dates from that date; the publication took place at intervals of 10 years from 1820 to 1942. There were 05 issues published at intervals of 5 years between 1942 and 2000. It started being published annually in 2002. It appeared in 1888 that the United States began producing a national formulary. U.S. Pharmacopeia 21-NF16 has eight supplements. Originally published in January 1985 and last published in November 1988. As of 1990, USP & NF have been consolidated into a single volume by the USP22-NF17 revision. USP-NF was released on floppy disks in 1992 as an electronic version. Published by the USP 23-NF18 in Mumbai, India at the end of 1994. Ten supplements are included in USP23. Published for the first time in January 1995 & last for the last time in May 1999 - Originally appeared in the USP 24-NF19 on January 1st, 2000. This was published as United States Publication 30-NF25 in May 2007 - Contains standard dietary substances, biological products, and excipients used in dosage forms of drugs, dietary supplements, and biological products. About 4100 monographs are contained in this book. There are three volumes in this work. In Volume I, there are general chapters, while Volume II, III hold monographs. In August 2007, there was a 1 st supplement to USP30-NF25, and from November 2007, there was a 2nd supplement that became official in May 2008. USP is also available in Spanish starting in 2006.

U.S. Pharmacopeia 30 and National Formulary 25:
Heavier paper stock is being introduced. CD-ROM with special instructions for using USP-NF print, It features a convenient slipcase that makes it easy to access and store (English edition only).

National Formulary 26 - State Pharmacopoeia 31:
Two of the most authoritative compendia are included in this volume: The United States Pharmacopeia and the National Formulary. In the USP, drug substances and preparations are described in monographs, and dietary supplements, ingredients, and other factors are outlined in a separate section. A monograph on each of the excipients is included in the NF.

National Formulary 27 - States Pharmacopoeia 32:
The collection consists of nearly 4,200 monographs. The text contains over 200 chapters that deal with general tests and assays. Provides user-friendly guides and charts that help you find information based on your interests. Updates on emerging scientific fields and medical advances, Makes sure official standards are being followed. Testing results can be validated against established benchmarks. Establishes operational procedures and specifications for the company, Develops new products and expedites approvals.

National Formulary 28 - State Pharmacopoeia 33:
A monograph collection of over 4,400 books is included in the collection. The general chapters cover over 200 tests and analyses. The monograph format has been updated, making it easier to read. You can find focus-specific information easily with helpful guides and charts. Makes sure that standards are being met, Standards of operation and specifications are developed within the company. New products developed and approved.

National Formulary 29 of the United States Pharmacopoeia 34:
The book was published in 2011. USP 34-NF 29 also offers handbooks on dispensing staff training, safety methods, and dispensing forms, dosages, excipients, oral biologics, and dietary supplements. The United States Pharmacopeia 34-NF 29 provides a full range of laboratory tests guidelines and validation procedures, as well as harmonizing and providing more than 230 General Chapters.

National Formulary 30 - State Pharmacopoeia 35:
In addition to USP-NF, there is National Formulary (NF) that was merged from the end of April 2012 to the initiation of 2013.

National Formulary 36 - States Pharmacopoeia 41:
It was released in 2018. Almost 5000 monographs are comprising 350 essays and, including sections on solutions, reagents, indicators. It also has a dangerous drug handling section.

Impurities in medical agents
Impurities are defined as any component of a pharmaceutical that is different from the entity defined as the active ingredient. Additionally, any ingredient that is not an essential component of a drug product is considered an impurity. Manufacturers of APIs must watch out for three different kinds of impurities in their products.

Organic components
Organic pharmaceutical impurities are often associated with a processing step or a drug. As the process of synthesis, purification, and storage of drugs takes place, these contaminants will likely occur. Chemical impurities are residual solvents leftover after drug compounds have been synthesized or when excipients are used to make drug formulations.

Inorganic impurities
Impurities in organic materials are often the result of manufacturing processes. You may also find reagents, ligands, catalysts, heavy or residual metals, organic salts, filter aids, and charcoal in the sample. Analyzing and quantifying inorganic contaminants is possible using pharmacopeial standards.

Residual solvents
As a third type of impurity, residual solvents appear in pharmaceuticals. A solvent used in pharmaceutical production is divided into three classes according to its toxicity. Solvents in the class one category should never be used since they are human carcinogens or environmentally hazardous. Solvents classified as class two should only be used in limited quantities since they could pose a harmful level of toxicity. Humans are not at risk from class three solvents.

Organic impurities aren't the only impurities found in pharmaceuticals, as it is also possible to find inorganic impurities and residual solvents. There are many causes of impurities, including manufacturing processes, degradation, storage conditions, and excipients and contaminants. Pharmaceutical products would be unsafe, ineffective, and of poor quality without the identification and elimination of impurities.
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