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LIMIT TEST AND PHARAMACOPOEIA, Schemes and Mind Maps of Pharmaceutical Chemistry

LIMIT TEST AND PHARMACOPOEIA .

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Shiva Institute of Pharmacy
PHARMACEUTICAL INORGANIC CHEMISTRY
1
st
SEMESTER (BP-104T)
UNIT I
Prepared By:-
Ankita Sharma
Assistant Professor
Department of
Pharmaceutical
Chemistry
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Shiva Institute of Pharmacy

PHARMACEUTICAL INORGANIC CHEMISTRY 1 st SEMESTER (BP-104T) UNIT I Prepared By:- Ankita Sharma Assistant Professor Department of Pharmaceutical Chemistry

PHARMACOPOEIA

⚫ Derived from Greek word ‘Pharmakon’ means drug and ‘Poiea’

means to make.

⚫ It is a legal and official book issued by recognized authorities

usually appointed by Government of each country.

⚫ It comprises list of pharmaceutical substances, formulae along with

their description and standards.

⚫ List of Pharmacopeias:

a) Argentine b) Austrian c) Belgian d) Brazilian e) British

f) Chinese g) Egyptian h) European i) French j) German

k) Hungarian l) Indian m) International n) Italian o) Japanese

p) Yugoslavian q) Mexican r) Netherlands s) Nordic t) Polish

u) Portuguese v) Rumanian w) Russian x) Spanish y) Turkish

z) United state.

INDIAN PHARMACOPOEIA ⚫ First official Pharmacopeia of India appeared in 1868 which was edited by Edward John Waring. ⚫ In preindependence days, British Pharmacopeia was used in India. ⚫ The colonial addendum of BP 1898 was published in 1900 appeared as Government of India edition in 1901. ⚫ In 1946 Government of India issued one list known as „The Indian Pharmacopeial list‟ ⚫ Committee under chairmanship of Sir R. N. Chopra alongwith other nine members prepared „The Indian Pharmacopeial list‟ ⚫ It was prepared by Dept. of Health, Govt. of India, Delhi in 1946. ⚫ In 1948 Government of India appointed an Indian Pharmacopeia committee for preparing „Pharmacopeia of India‟ ⚫ Tenure of this committee was five years. ⚫ Indian Pharmacopeia committee under chairmanship of Dr. B. N. Ghosh Published first edition of IP in 1955.

INDIAN PHARMACOPOEIA ⚫ Third edition of IP was published in 1985 with two volumes & nine appendices. ⚫ 261 new monographs have been added. ⚫ 450 monographs were deleted. ⚫ Addendum I to IP was published in 1989 were 46 new monographs added and 126 amended. ⚫ Addendum II was published in 1991 were 62 new monographs added and 110 amended. ⚫ Fourth edition of IP was published in 1996 under the chairmanship of Dr. Nityanand. ⚫ It has been made effective from 1 st December 1996. ⚫ It covered 1149 monographs and 123 appendices. ⚫ It includes 294 new monographs & 110 monographs have been deleted. ⚫ Addendum I has been made effective from 31 st December 2000 were 42 new monographs have been added. ⚫ Addendum II has been made effective from 30 th June 2003 were 19 new monographs have been added. ⚫ The veterinary supplement to IP 1996 contains 208 monographs & four appendices.

INDIAN PHARMACOPOEIA ⚫ Fifth edition of IP was published in 2007 & addendum to this edition was published in 2008.IP 2007 is presented in Three Volumes. ⚫ Volume One contains general notices & general chapters. ⚫ Volume Two & Three contains general monographs on drug substances , dosage forms & Pharmaceutical aids.

INDIAN PHARMACOPOEIA 2010

⚫ Volume III contains Monographs on drug substances,

dosage forms and pharmaceutical aids (N to Z).

⚫ Followed by Monographs on Vaccines and Immunosera for

Human use, Herbs and Herbal products, Blood and blood-

related products, Biotechnology products and Veterinary

products.

⚫ The scope of the Pharmacopoeia has been extended to

include products of biotechnology, indigenous herbs and

herbal products, veterinary vaccines and additional

antiretroviral drugs and formulations, inclusive of commonly

used fixed-dose combinations. Standards for new drugs and

drugs used under National Health Programmes are added

and the drugs as well as their formulations not in use now a

day are omitted from this edition.

INDIAN PHARMACOPOEIA 2010 ⚫ The number of monographs of Excipients, Anticancer drugs, Herbal products and antiretroviral drugs has been increased in this edition. ⚫ Monographs of Vaccines and Immunosera are also upgraded in view of development of latest technology in the field. ⚫ A new chapter on Liposomal products and a monograph of Liposomal Amphotericin B injection is an added advantage in view of latest technology adopted for drug delivery. ⚫ A chapter on NMR is incorporated in Appendices. ⚫ The chapter on microbial contamination is also updated to a great extent to harmonise with prevailing international requirements.

Seventh Edition of Indian Pharmacopoeia ⚫ A list of 577 New Monographs not included in IP-2010 and its Addendum-2012 but added in this edition containing 313 New Monographs on drug substances, Dosage forms & Pharmaceutical aids (A to Z), 43 New Drugs Substances Monographs, 10 Antibiotic Monographs, 31 Herbal Monographs, 05 Vaccines & immunosera for human use, 06 Insulin Products, 07 Biotechnology Products etc. along with the 19 new General Chapters. ⚫ 19 New Radiopharmaceutical Monographs & 1 General chapter is first time being included in this edition. ⚫ This edition of Indian Pharmacopoeia- 2014 is now under printing and will be available to stakeholders probably in Sept.2013, before three months of its effective date, i.e. 1 st Jan. 2014.

INDIAN PHARMACOPOEIA