This document provides an overview of pharmaceutical inorganic chemistry and the history of pharmacopoeias. It discusses how pharmaceutical inorganic chemistry studies inorganic substances used as drugs, and how pharmacopoeias set quality standards for drugs. The document outlines the contents of pharmacopoeias including monographs describing drugs' names, properties, purity standards, and approved tests. It provides a brief history of major pharmacopoeias like the USP and IP, and describes the development and editions of the Indian Pharmacopoeia since 1944.

1. Pharmaceutical Inorganic chemistry
UNIT-I (Part-I)
Introduction of Inorganic Chemistry, History of
Pharmacopoeia
Presented By
Ms. Pooja D. Bhandare
(Assistant Professor)
DADASAHEB BALPANDE COLLEGE OF PHARMACY BESA NAGPUR

2. CONTENTS
•Introduction of Pharmaceutical Inorganic Chemistry’
•Introduction of Pharmacopoeia
•Sources and types of Impurities.
•Limit test

3. INTRODUTION OF PHARMACEUTICAL
CHEMISTRY
• Pharmaceutical chemistry is a science that makes use of general laws of
chemistry to study drug, i.e., their preparation, chemical nature, composition,
structure, influence on an organism and studied, the physical and chemical
properties of drugs, the method of quality control and the conditions of their
usage.
• In other words, it is the chemistry of drug.

4. PHARMACEUTICAL CHEMISTRY
INORGANIC ORGANIC MEDICINAL ANALYTICAL PHYSICAL
CHEMISTRY CHEMISTRY CHEMISTRY CHEMISTRY CHEMISTRY

5.  INORGANIC CHEMISTRY:
• “Inorganic chemistry deals with the study of all elements and their
compounds except for the hydrocarbons and their derivatives.”
• Inorganic compound will never contain carbon and hydrogen together but
individually carbon and hydrogen contain any atom. (eg CO2, H2O and Hcl
etc.)
• Inorganic pharmaceutical chemistry is a science that makes use of laws of
chemistry to study inorganic substances as drug, i.e., their preparation,
chemical nature, composition, structure, influence on an organism, etc

6. • It describes the characteristics of substances obtained from non-living
things/matter and minerals which are found in the earth except the class of
organic compounds.
• Examples: sodium chloride (NaCl) used as tablet salt, silicon dioxide
(SiO2) used as computer chips, sulphuric acid (H2SO4) used in production
fertilizers.

7. IMPORTANTS OF INORGANIC CHEMISTRY
• Those that find use for replacing the normal content of the body. These
are required for normal physiological processes and are required in diet. But
disease condition are able to deplete their amounts in the body hence they
are replaced. Calcium, sodium, potassium, magnesium, iron, chloride,
phosphate, bicarbonate and oxygen etc are example o this category.
• Those that are used for changing reaction of body fluids, i.e., Acidify or
alkalise . mineral acids, antacids, alkalis etc., belong to this category.

8. • Those that find use as medicinal and therapeutic agent in disease condition.
Those may be able to change physical (e.g., Topical agent, protectants),
Physiological and/or biochemical process (e.g., Astringents, respiratory
stimulants, hypnotics, expectorant)
Some may be used as corrective or in infections (e.g., Dental products,
antidotes, antimicrobial etc.)
• Those that find use as pharmaceutical aids. Bentonite, talc, antioxidant,
pigments etc. Are example of this category
• Those that find use in analytical and quality control process. Use as titrants
such as potassium permanganate EDTA

9. • Those that find use as reagents for carrying out the reactions.
Some use as catalyst (platinum, nickel, charcoal etc .)
Some use as oxidizing or reducing (chromic acid, lithium
aluminium hydrate etc).
Some use as adsorbent in chromatography ( alumina, silica gel
etc.)

10.  INTRODUCTION OF PHARMACOPOEIA
• Pharmacopoeia: the word derived from the ancient Greek word phrmakon
means drug & poeia means to make.
• Pharmacopoeia is a book of directions and requirement for the preparation
of medicine; is generally published by an authority.
• Thus pharmacopoeia is a legislation of a country which sets of standard and
obligatory quality indies for drug, raw material used to prepare them and
various pharmaceutical preparations.
Phrmakon
(means drug)
Poeia (means
to make)
Phrmacopoeia

11. • It is a legally binding collection, preparation by national
or regional authority & contain list of medicinal
substances, crude drug & formulas for making
preparation from them.
• The list of pharmaceutical substance, formulae along with
their description and standards. Sources, test, uses,
dosage & storage condition.

12. TYPES OF PHARMACOPOEIA
National Pharmacopoeia:
United State Pharmacopoeia (USP)
Indian Pharmacopoeia (IP)
British Pharmacopoeia (BP)
German Pharmacopoeia (GP)
Japanese Pharmacopoeia (JP)
 Pharmacopoeia of the People’s Republic of China (PPRC)
 Regional Pharmacopoeia:
 European Pharmacopoeia
 International Pharmacopoeia:
European Pharmacopoeia

13. HISTORY OF PHARMACOPOEIA
• The first United State Pharmacopoeia (U.S.P) was released on 15th December,
1820
• The first British Pharmacopoeia (B.P.) was published in 1864. It was including
monographs on benzoic acid, gallic acid, tartaric acid, tannic acid, camphor,
lactose, sucrose and alkaloids with their salts.
 HISTROY OF INDIAN PHARMACOPOEIA
• In India, in the pre-independence days, B.P. was employed as the official
book of standard.
• In Indian, the first pharmacopoeia had been publishes as “ Bengal
Pharmacopoeia” in 1844.

14. • The Government of India Constituted a Permanent India Pharmacopeia
Committee (IPC) in 1948 for preparing Indian under the chairmanship of Dr.
B. N. Ghosh.
• The first edition of the Indian Pharmacopoeia (I.P.) was published in 1955. It
was having large number of crude drug and their preparation.
• Indian Pharmacopoeia Commission (IPC) is an autonomous institution of the
ministry of Health and Family Welfare which sets standard for all drugs that
are manufactured, sold and consumed in India

15. List of Publications of various Edition of Indian
Pharmacopoeia
INDIAN PHARMACOPOEIA (I.P)
Edition Year Supplement/Addendum Volume
I st 1955 1960 1
II nd 1966 1975 1
III rd 1985 1989/1991 2
IV th 1996 2000/2002/2005 2
V th 2007 2008 3
VI th 2010 2012 3
VII th 2014 2015/2016 4
VIII th 2018 2019/2021 4
IXth 2022 4

16. • 1944 : Process of publishing first Pharmacopoeia started.
• 1948 : Government of India appointed Indian Pharmacopoeia Committee for
preparing Pharmacopoeia of India.
• 1955 : 1st edition of I.P. 1955 was published under the chairmanship of Dr. B.
N Ghosh.
• 1960 : Supplement of 1st edition (1955) was published.
• 1966 : 2nd edition of I.P. 1966 was published under the chairmanship of Dr. B.
Mukherjee.
• 1975 : Supplement of 2nd edition (1966) was published

17. • 1985 : 3rd edition of I.P. 1985 was published under the chairmanship of Dr.
Nityanand
• 1989 : Supplement of 3rd edition (1985) was published.
• 1991 : Supplement of 3rd edition (1985) was published.
• 1996 : 4th edition of I.P. 1996 was published under the chairmanship of Dr.
Nityanand 1966
• 2000, 2002 & 2005: Supplement of 4th edition (1996) was published.
• 2007 : 5th edition of I.P. 2007 was published under the chairmanship of Dr.
Nityanand

18. • 2008 : Supplement of 5th edition (2010) was published.
• 2010 : 6th edition of I.P. 2010 was published Under the chairmanship Shree.
K Chandramouli.
• 2012 : Supplement of 6th edition (2010) was published
• 2014: 7th edition of I.P. 2014 was published by behalf of Government of
India under the chairmanship of Ghulam Nabi Azad.
• 2015, 2016 : Supplement of 5th edition (2014) was published.
• 2018 : 8 th edition of I.P. 2018 was published by behalf of Government of
India under the chairmanship of Dr. C. K. Mishra

19. • 2019, 2021 : Supplement of 8th edition (2018) was published.
• 2022 : 9 th edition of I.P. 2022 was published by behalf of Government
of India Under the Chairmanship Of Dr. C. K Mishra

20. CONTENT OF PHARMACOPOEIA
• Mostly al pharmacopoeia consists of three main sections
namely.
a) Introduction including general Notices
b) Monographs of the official drugs
c) Appendices

21. a) Introduction:
• It is useful pointer to pharmaceutical progress since last edition
because it summaries the various changes / addition / deletions in
the current edition. Attention should be paid to general notices” at
the outset so as to avoid misunderstanding and misinterpretation of
later parts of the text.

22. b) Monograph
• What is Monograph ?
• Definition : Monograph is a complete description of a specific
pharmaceutical, which includes nomenclature, classification, physical
characteristics, dosage, purity, limits for impurities, identification, assay and
storage conditions.
• Purpose of Monograph.
• Provide Scientific information on the safety, efficacy and quality control/
quality assurance widely used medicinal plant.

23. CONTENT OF MONOGRAPH
1) Title : The title is started in English and refers to the official name of the
compound. Some time sub-title are given. These are synonyms and could be
used in place of main tittle.
e.g., calcium carbonate can also be called precipitated chalk, iron and
ammonium citrtate can also called ferric ammonium citrate and milk of
magnesia can also be called magnesium hydroxide mixture.
2) Formula weight and molecular weight : Following the title has been the
chemical formula of the pure compound, with its molecular weights.
e.g., MgCl2. 6H2O Mol.wt. 202.30 , KMNO4 Mol. Wt. 158.03 tc

24. 3) Category: These describes the therapeutic or pharmacologic or
pharmaceutical application, although the compound may be having other
application. Some main categories for inorganic pharmaceuticals mentioned
in pharmacopoeia. e.g., antacid, haematinic, laxative, pharmaceutical aid ,
astringent etc.
4) Dose: These are the quantity for the guidance of the prescriber or the
physician to achieve the desired therapeutic effects in adults. It can be altered
when its required, e.g., CaCO3 dose 1to 5 gm.
This is omitted for substance not used for internal administration, Usual
strength may be given for pharmaceuticals dosage form, like injection etc.,
which is most commonly marketed strength.

25. 5) Description: This give the physical description of the substance like
crystalline or amorphous, nature, colour, odour, taste, etc. These properties
help in preliminary evaluations of the integrity of an article and not
themselves the standard or test of purity, e.g., CaCO3 fine, white
microcrystalline powder, odourless, tasteless.
4) Solubility : Solubility is described in popular terms, which are defined in
the pharmacopoeia under the general notices. This is usually given in water,
sometimes in hot or boiling water, in alcohol, in glycerol, in solvent ether and
other organic solvents, acid or alkalis.

26. 7) Standard: It is an important part of monograph, which specifies the
quantitative purity of the title compound, where the compound is definite
composition, e.g., 1) Potassium bromide is having not less than 98.0% of KBr
with reference to dried substance.
8) Identification: This is usually involves specific chemical test for identify
the substance. Colour reactions, precipitating test, and gas evolving reactions
are commonly used for inorganic pharmaceuticals.
e.g., Phenol + FeCl3 solution gives violet colour.
9) pH : The pH values given in the monograph are for the guidance of
manufacturing pharmacist to avoid physiological complications, e.g., calcium
ammonia salicylate. 2 per cent w/v solution gives pH 6.0 – 8.0 .

27. 10) Limits for impurities: For different chemicals different limit tests have been
included, as also different amounts of such impurities permissible for that chemical.
The various test that are included could be any of these: acidity or alkalinity, pH,
specific impurities (like phosphate, sulphides, magnesium, barium etc.), arsenic,
heavy metals, chloride, sulphate etc. Limit tests for impurities are generally
represented in part per million by weight (ppm) or as percentage. These are
approximate values.
11) Assay: (Testing the object to determine the purity and integrity)
It is a step-by step description of chemical analytical method for active substance. If
the assay method described in the pharmacopoeia is applied to the chemical, the
standards prescribed in the monograph earlier should be realized. For most inorganic
pharmaceuticals, titrimetric or gravimetric methods are used

28. 12) Storage: This is the last item under the monograph. These directions are
useful in preserving the activity of the chemical. These are generally brief and
general, intended more as guidance than as conditions.
For inorganic pharmaceuticals, the pharmacopoeia uses the term a) well-closed
container, b) tightly- closed containers c) light-resistance containers; amber or
dark- coloured containers d) cool place e) Single dose containers

29. C) Appendices
• The General Notices and Monographs are followed by a comprehensive
section appendices
Appendix Number Type of Appendix
1 Apparatus for test and Assay
2 Biological Test and Assay
3 Chemical Test and Assay
4 Microbiological Test and Assay
5 Physical Test and Determinations
6 General information
7 Reagent and solution
8 Reference Substance
9 Tables

30. Thank You !