Pharmaceutical Inorganic Chemistry -B Pharmacy First Year -First semester -PIC PPT 1-Impurities-Pharmacopoeia (1).pptx

1.  By Manjusha SK
 Associate professor

2.  Introduction
 Pharmaceutical chemistry-
 The Pharmaceutical chemistry is a branch of chemistry which deals with
the study of medicinal and pharmaceutical products (drugs).
 It includes the study of chemistry with its all the aspects i.e.organic
chemistry,inorganic chemistry,analytical chemistry and medicinal
chemistry also.
 It is nothing but the chemistry of drugs/medicine.
 It occupies a vast area of pharmacy as it play a vital role in preparation
drugs/medicines.

3.  Pharmaceutical Inorganic chemistry –
 Pharmaceutical Inorganic chemistry is the science which deals with the
study of inorganic drugs (substances) i.e.their molecular weight,molecular
formula,method of preparation,physico-chemical properties,their
identification,analysis,structural elucidation and finally its pharmaceutical
and therapeutical use.
 Inorganic chemistry deals with study of carbon free compounds means
compound not having carbon in its structure.
 Eg.drugs from natural sources like salts,minerals,plants,animals,calcinied
inorganics (ash/bhasma),inorganic metals (gold,silver,mercury etc).
 Pharmaceutical Inorganic chemistry has applications in every aspects of
chemical industries including coating,catalysis,pigments,material
science,medications,fuels and in agriculture also.
 The scientist Alfred Werner has been called the father of modern
inorganic chemistry and he was awarded by a Nobel prize in 1913

4.  The word pharmacopoeia derived from the greek word ,
Pharmakon-means a drug /medicine and poieo-means to make.
 This book gives not only the information regarding how to prepare a new
drug /medicine but also it contains the various directions for the
preparation of drugs /medicines.
 The pharmacopoeia book published by the authorized unit of government
or a medical /pharmaceutical society.
 The pharmacopoeia containing the description regarding preparation of
drugs/medicines are called as monographs.
 History of Pharmacopoeia -
 In world every country having their own legislation for the preparation of
pharmaceutical products and they set the standards and obligatory quality
indices for the new drugs / medicaments,raw materials and also their
method of preparation which carried out in the manufacturing of drugs.
 All such specifications related to drugs were published in a book called as
pharmacopoeia.
 The first pharmacopoeia was published as United States pharmacopoeia
(USP) in the year 1820 and after that British pharmacopoeia (BP) in the
year 1864.


5.  Before the independence in India British pharmacopoeia was used as the
official book for the preparation of drugs/medicines.
 By considering the states in India the first pharmacopoeia had been
published as Bengal pharmacopoeia in 1844.
 For the compilation of Indian pharmacopoeia the government of India
constituted a permanent Indian pharmacopoeia Committee in 1948,under
the chairmanship of Dr.B.N.Ghosh.
 The first edition of Indian pharmacopoeia was published in 1955.

6.  First Edition of Indian Pharmacopoeia (1955) –
 The first edition of Indian Pharmacopoeia was published in 1955 and
followed by its supplements/addendum in 1960.
 The First Edition of Indian Pharmacopoeia consist of large number of
crude drugs with 986 monographs.
 The title of monographs are written in latin language.
 Titles are given in abbreviated form.
 The information regarding the weights and measures given in metric
system.
 Second Edition of Indian Pharmacopoeia (1966) –
 The second edition of Indian Pharmacopoeia was published in 1966 and
followed by its supplements/addendum in 1975.
 The Second Edition of Indian Pharmacopoeia consist of 93 monographs.
 The titles of monographs changed from latin to English.

7.  Third Edition of Indian Pharmacopoeia (1985) –
 The third edition of Indian Pharmacopoeia was published in 1985 under the
chairmanship of Dr.Nityanand.
 The addendum/supplements for this edition made in the year 1989 and 1991.
 The total 260 new monographs were added.
 The general notices and appendices included in this edition.
 The analytical techniques like fluorometry,conductometry,flame photometry
were introduced.
 Fourth Edition of Indian Pharmacopoeia (1996) –
 The fourth edition of Indian Pharmacopoeia was published in 1996.
 The addendum to 4th edition has been made in 2000 followed by 2002 and
2005.
 It consist of 1149 monographs and 123 appendices which is divided into two
volumes
 Volume l consist of information regarding general notices and contains
monographs (A - O).
 Volume ll contains monographs (P - Z).
 The supplement 2000 released for veterinary products in two parts,part l deals
with the non –biological preparations whereas part ll covers biological
preparations.
 The supplement 2005 released for Antiretroviral drugs.
 In 2005 the IPC (Indian pharmacopoeia committee) had been established.
 .

8.  Fifth Edition of Indian Pharmacopoeia (2007) –
 The fifth edition of Indian Pharmacopoeia was published in 2007.
 The addendum to fifth edition has been made in 2008.
 Added 72 new monographs.
 It is consist of three volumes.
 Sixth Edition of Indian Pharmacopoeia (2010) –
 The sixth edition of Indian Pharmacopoeia was published in 2010.
 The addendum to fifth edition has been made in 2012 by the scientific
body of IPC.
 It is also consist of three volumes.
 Volume l comprises notices,about the IPC etc.
 Volume Il consist of general notices,general monographs (A - M).
 Volume lII contains monographs (N - Z),dosage forms,vaccines,blood and
blood related products.
Seventh Edition of Indian Pharmacopoeia (2014)
 The seventh edition of Indian Pharmacopoeia was published in 2014 in
four volumes with DVD.
 It consist of total 2548 monographs,577 are the newly added.
 First time 19 radiopharmaceuticals were introduced in seventh edition of
IP.
 It also consist of biotechnology products,herbal products,vaccines etc.

9.  The BP was published by health minister of United Kingdom.
 first edition of BP was published in 1864 – It includes the two parts
Materia medica and preparation and compounds.
 It is an outcome obtained by combining Pharmacopoeia Londinesis
(1618),Edinburgh Pharmacopoeia (1699) and Dublin Pharmacopoeia
(1807).
 The second edition of BP was published in 1867.
 The Third edition of BP was published in 1885 .
 The Fourth edition of BP was published in 1898.
 The Fifth edition of BP was published in 1914.
 The Sixth edition of BP was published in 1932.
 After the 1932 BP must be revised for every ten years.
 The Seventh edition of BP was published in 1948-This edition contains 49
tablet preparations and 75 injections.
 After this it was decided that the interval between new edition should be
5 year instead of 10 years.

10.  The Eighth edition of BP was published in 1953.
 The Ninth edition of BP was published in 1958 .
 The Tenth edition of BP was published in 1963.
 Now the British Pharmacopoeia started to publish their editions in two
volumes due to the expansion of drug information.
 The Twelth edition of BP was published in 1973.
 The Fourteenth edition of BP was published in 1988.
 The Sixteenth edition of BP was published in 2000 consisting of veterinary
products.

11.  The country France,Italy,Netherland,Germany and Switzerland adopted
European Pharmacopoeia.
 This Pharmacopoeia was considered as official book for the preparation of
drugs /medicines.
 In 1964 the European Pharmacopoeial commission issued an authority to
compile the European Pharmacopoeia.
 The first European Pharmacopoeia was published in 1969.

12.  The first USP was published in 1820,consisting of 217 drugs.
 The second edition was published after ten year of gap.
 In 1940 it was decided that pharmacopoeia must be revised after every
five years.
 The USP and NF (National Formulary) were work together for determining
the standards of pharmaceutical products.
 The USP covers the drug products whereas NF pharmaceutical
ingredients.


13.  It is also considered as a reference book for the preparation of new
medicaments.
 It consist of two part,
 Part l – deals to maintain the quality of medicines /pharmaceutical
products from its development to its use.
 Part ll – It includes collection of pharmaceutical information and arrange
them into the monographs.

14.  It is considered as the complete reference book.
 It was published by William Martindale in1883 under the
title,Martindale:The Martindale contains information of drugs in clinical
use worldwide as well as selected investigational, veterinary drugs, herbal
drugs, pharmaceutical excipients and nutritional agents.

15.  The Pharmacopoeial description consist of three main parts/sections,
 A.Introduction –General Notices
 B.Monographs of the official drugs
 C.The Appendices
 A.Introduction –General Notices
 It is an important parameter to know the pharmaceutical progress from
the last edition to the recent one.
 It consist of the various changes,which may be additions/deletions in the
latest/current edition related to the last edition.
 B.Monographs of the official drugs –
 The word mono means single/one and graphs means to write,so it deals
with the written data/information of the drug/medicine.
 As the drugs /medicines are very important to cure and / prevent the
disease /disorder so their written data /study (of drugs/medicine) must
appear/included in pharmacopoeia and termed as the Monograph.

16. 1.Title –
 It is referred as an official name of drug/compound and it is stated in
English .
 It covers the synonym or common name of drug and may be placed in
place of main title.eg. magnesium hydroxide also called as milk of
magnesia.magnesium sulphate is also called as Epsom salt.
 2.Chemical formula and Molecular weight –
 Where ever necessary after the title of drug the chemical formula and its
molecular weight must be mentioned in the monograph.eg.magnesium
hydroxide
 Its chemical formula is - Mg(OH)2 and molecular weight is 58.3197 g/mol.
 3. Category-
 The category of a drug/compound indicates its
pharmaceutical/pharmacological/therapeutical application/use.
 It indicates main application/use of drug/compound but many
drug/compound may have some additional use /application also.
 eg magnesium hydroxide -Its main category is Antacid,but is also used as
laxative.
 eg.Ammonium chloride,Its main category is Expectorant but it is also used
as a nitrogen supply in fertilizers and as an electrolyte in dry cells.

17.  4.Dose –
 These are quantities or average range of quantities given to an adult as
per the directions of physicians.
 Eg.Magnesium oxide light-dose is 0.3 to 0.6g.
 magnesium hydroxide dose is 5 to 10ml as an antacid and 15 to 30ml as
an laxative.
 5.Description –
 It includes the physical properties of a drug substances.
 Properties related with state of drug, its colour,taste,odour, nature etc.
 Eg.Calcium carbonate – it is fine,white,micro-crystalline powder.it is
odourless,colourless and tasteless.
 6.Solubility –
 It is given in Pharmacopoeia under the general notices,usually given in
water,sometimes may be in boiling/hot water and in alcohol also.

18.  7.Standard –It gives information about the purity and strength of
drug/compound.It ensure the quality and safety of the essential
medicines by providing analytical methods and appropriate testings.
 eg.Potassium bromide –having not less than 98.0% of KBr,calculated with
reference to the dried substances.
 8.Identification- It deals with some specific and non-specific tests for the
identification of drug/compound.
 It includes prepitation reaction,colour changing reactions etc are used for
inorganic chemicals.
 The identification tests are not absolute proof of the identity of
drug/compound,it only for the purpose of verification of drug/compound.
 Eg.Phenol + FeCl3 solution gives violet colour.
 9.pH – It is an important parameter that reflects the chemical conditions
of a solution.The Ph values given in the monograph for the guidance of
manufacturing pharmacist to develop/produce various dosage forms and
to avoid physiological complications.

19.  10.Tests for impurities –
 It includes the various limit tests which are carried out to determine the
inorganic impurities present in the drug/compound.
 For different chemicals different limit tests has been mentioned.
 Eg.limit test for chloride,sulphate,heavy metals etc.
 These are represented in parts per million (ppm) by weight or as a
percentage.
 11.Assay –
 It is a systematic process for analyzing the subsasnce/compound to
determine its composition /quality.
 It provide stepwise process for the active substance.

20.  12.Storage – There are various storage conditions are given for the
storage of pharmaceutical preparations/drugs.
 If no specific directions are mentioned,then store the product away from
moisture,heat (light) and freezing.
 In IP various important storage conditions are mentioned in order to
prevent the contamination of pharmaceutical preparations/drugs in terms
of following terms.
 1.Well closed container – The product get protected from environmental
dust,dirt and insects etc,which are getting into container.
 2. Air –tight container – such container protects the product against
atmospheric oxygen,moisture and carbon di-oxide.
 Means the storage condition deals with the various precaution
parameters to be taken against moisture,heat and freezing for any
pharmaceutical preparations/drugs.

21.  13.Appendices –
 It is an comprehensive section given in the pharmacopoeia after the general
notices and monographs.
 Appendix l – It describes about the various apparatus needed for the various
pharmacopoeial tests and assays.
 Appendix ll – It includes the information about biological tests and assays.
 Appendix lll – It includes details of various chemical tests and assays.
 Appendix IV - It includes details of various microbiological tests and assays.
 Appendix V – It includes some physical tests and determinations like LOD
(Loss on drying),MP (Melting point),Ph etc.
 Appendix Vl – It includes the various useful directions for cleaning the
glassware.
 Appendix Vll – It consist of information about various reagents and solutions
needed in various tests and assays with their method of preparation.
 Appendix VIII – It includes the information about the reference substances.
 Appendix IX – It includes the information about the names and symbols used
in pharmacopoeia for weights, measures and elements with their atomic
weight.

22.  THANK YOU