A Text Book Of

PHARMACEUTICAL INORGANIC
CHEMISTRY
As Per PCI Regulations

FIRST YEAR B. PHARM.

Semester I

Dr. Shivakumar Swamy Bidya Bhushan

M. Pharm. Ph.D. M. Pharm.
Principal & Professor Associate Professor,
Mallige College of Pharmacy Department of Pharmaceutical Chemistry
# 71, Silvepura Chikkabanavara post Mallige College of Pharmacy
Bangalore – 560090 # 71, Silvepura Chikkabanavara post
Bangalore - 560090

Dr. Sanjay G. Walode

M. Pharm., Ph.D. (Pharmaceutical Chemistry)
Professor & HOD
SETE's, Sinhgad Institute of Pharmaceutical Sciences
Kusgaon (Bk), Lonavala, Pune – 410401, India

Price ` 175.00

N4319
PHARMACEUTICAL INORGANIC CHEMISTRY ISBN 978-93-86700-60-5
Second Edition : April 2018
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Preface

We are pleased to present this text book of Pharmaceutical Inorganic Chemistry

to the students of First Year B. Pharm, Semester – I.

This text book is written with a view to cover new syllabus framed for semester – I
B. Pharm Students by Pharmacy Council of India as per education regulations 2014.

The book has been divided into respective chapters as mentioned in the syllabus.
Every inorganic compound included in this book has been discussed under definition,
preparation, properties, identification, assay method, storage condition and uses. This
book also includes some general topics such as Impurities in Pharmaceutical substances
and their limit test and radio pharmaceuticals.

We hope this book will prove useful to the students and teachers of semester – I
B. Pharm course.

We express our sincere thanks to publisher Shri. Dineshbhai K. Furia, Shri.

Jigneshbhai C. Furia, Nirali Prakashan for publishing this book. We extend our sincere
thanks to the team of Nirali Prakashan namely Santosh Bare, Anjali Muley, Roshan
Shaikh and Ravindra Walodare for their immense contribution to the improvement of
the content and appearance of book. We will be glad to receive comments and criticism
for the improvement of this book.

Dr. S. K. Swamy
B. Bhushan
Dr. Sanjay G. Walode
Syllabus
UNIT I [10 Hours]
• Impurities in Pharmaceutical Substances: History of Pharmacopoeia, Sources and
types of impurities, principle involved in the limit test for Chloride, Sulphate, Iron,
Arsenic, Lead and Heavy metals, modified limit test for Chloride and Sulphate.
• General Methods of Preparation, assay for the compounds superscripted with asterisk
(*), properties and medicinal uses of inorganic compounds belonging to the following
classes.

UNIT II [10 Hours]

• Acids, Bases and Buffers: Buffer equations and buffer capacity in general, buffers in
pharmaceutical systems, preparation, stability, buffered isotonic solutions,
measurements of tonicity, calculations and methods of adjusting isotonicity.
• Major Extra and Intracellular Electrolytes: Functions of major physiological ions,
Electrolytes used in the replacement therapy : Sodium chloride*, Potassium chloride,
Calcium gluconate* and Oral Rehydration Salt (ORS), Physiological acid base balance.
• Dental Products: Dentifrices, role of fluoride in the treatment of dental caries,
Desensitizing agents, Calcium carbonate, Sodium fluoride, and Zinc eugenol cement.

UNIT III [10 Hours]

• Gastrointestinal agents
• Acidifiers: Ammonium chloride* and Dil. HCl.
• Antacid: Ideal properties of antacids, combinations of antacids, Sodium Bicarbonate*,
Aluminium hydroxide gel, Magnesium hydroxide mixture.
• Cathartics: Magnesium sulphate, Sodium orthophosphate, Kaolin and Bentonite.
• Antimicrobials: Mechanism, classification, Potassium permanganate, Boric acid,
Hydrogen peroxide*, Chlorinated lime*, Iodine and its preparations.

UNIT IV [08 Hours]

• Miscellaneous Compounds
• Expectorants: Potassium iodide, Ammonium chloride*.
• Emetics: Copper sulphate*, Sodium potassium tartarate
• Haematinics: Ferrous sulphate*, Ferrous gluconate
• Poison and Antidote: Sodium thiosulphate*, Activated charcoal, Sodium nitrite 333
• Astringents: Zinc Sulphate, Potash Alum.

UNIT V [07 Hours]

• Radiopharmaceuticals: Radio activity, Measurement of radioactivity, Properties of α, β, γ
radiations, Half life, radio isotopes and study of radio isotopes - Sodium iodide I131,
Storage conditions, precautions and pharmaceutical application of radioactive
substances.
❑❑❑
Contents
UNIT I
1. INTRODUCTION TO PHARMACEUTICAL INORGANIC CHEMISTRY 1.1 − 1.10
1.1 Importance of Inorganic Pharmaceuticals 1.1
1.2 Classification of Inorganic Pharmaceuticals 1.2
1.2.1 Classification based on their uses 1.2
1.2.2 Classification based on their applications (therapeutic classification) 1.6
Questions 1.10
2. PHARMACOPOEIA AND MONOGRAPHS 2.1 − 2.22
2.1 Introduction 2.1
2.2 History of Pharmacopoeia 2.3
2.2.1 Indian Pharmacopoeia 2.5
2.2.2 British Pharmacopoeia 2.9
2.2.3 United States Pharmacopoeia (USP) 2.12
2.2.4 Pharmacopoeia Internationalis (International Pharmacopoeia) 2.13
2.2.5 Martindale : The Extra Pharmacopoeia 2.14
2.2.6 Pharmaceutical Index 2.15
2.3 Pharmacopoeial Description/Presentation 2.16
Questions 2.22
3. IMPURITIES IN PHARMACEUTICAL SUBSTANCES AND LIMIT TESTS 3.1 − 3.26
3.1 Introduction 3.1
3.2 Impurity 3.2
3.3 Methods used to purify the inorganic substances 3.9
3.4 Test for Purity 3.10
3.5 Limit Test 3.12
3.5.1 Limit Test for chloride 3.14
3.5.2 Limit Test for sulphate 3.15
3.5.3 Limit Test for iron 3.16
3.5.4 Limit Test for heavy metal 3.17
3.5.5 Limit Test for lead 3.20
3.5.6 Limit test for arsenic 3.21
3.6 Modified Limit Test for Chloride and Sulphate 3.24
Questions 3.25
UNIT II
4. ACIDS, BASES AND BUFFERS 4.1 − 4.24
4.1 Introduction 4.1
4.2 Acids and Bases 4.1
4.3 Strength of Acids and bases 4.6
 4.4 Buffers 4.11
4.5 Buffer Action 4.12
4.6 Preparation of Buffer 4.14
4.7 Selection of pharmaceutical buffer 4.20
4.8 Iso-osmoticity and Isotonicity 4.20
4.9 Isotonic Buffers 4.22
Questions 4.24
5. MAJOR INTRA AND EXTRACELLULAR ELECTROLYTES 5.1 − 5.22
5.1 Introduction 5.1
5.2 Role of major physiological cations and anions 5.4
5.2.1 Sodium 5.4
5.2.2 Potassium 5.5
5.2.3 Calcium 5.5
5.2.4 Magnesium 5.6
5.2.5 Chloride 5.7
5.2.6 Phosphate 5.7
5.2.7 Bicarbonate 5.7
5.3 Electrolytes used for replacement therapy 5.8
5.4 Electrolytes combination therapy 5.13
5.5 Physiological Acid Base Balance 5.14
Questions 5.16
6. DENTAL PRODUCTS 6.1 − 6.10
6.1 Introduction 6.1
6.2 Tooth Anatomy 6.1
6.3 Dental products 6.2
6.3.1 Anticaries agent 6.2
6.3.2 Cleaning agents or dentifrices 6.5
6.3.3 Desensitizing agents 6.7
6.3.4 Cement and fillers 6.8
6.4 Zinc eugenol cement (ZOE) 6.8
Questions 6.9
UNIT III
7. GASTROINTESTINAL AGENTS 7.1 − 7.22
7.1 Introduction 7.1
7.1.1 Important parts of gastrointestinal tract and their functions 7.2
7.1.2 Classification of Gastrointestinal agents 7.2
7.2 Acidifiers 7.3
7.3 Antacids 7.4
7.3.1 Criteria for ideal antacids 7.5
7.3.2 Classification of antacids 7.5
 7.4 Combinations of Antacids 7.14
7.5 Cathartics 7.15
7.6 Protective and Adsorbents 7.18
Questions 7.21
8. TOPICAL AGENTS (PROTECTIVES, ASTRINGENTS & ANTI-MICROBIALS 8.1 − 8.16
8.1 Introduction 8.1
8.2 Astringent 8.5
8.3 Antimicrobial Agents 8.7
Questions 8.16
UNIT IV
9. MISCELLANEOUS COMPOUNDS 9.1 − 9.20
9.1 Expectorant 9.1
9.1.1 Introduction 9.1
9.1.2 Classification of expectorants 9.2
9.2 Emetics 9.5
9.3 Haematinics 9.8
9.3.1 Introduction 9.8
9.3.2 Iron as a Haematinics 9.9
9.3.3 Causes for iron deficiency anemia 9.10
9.3.4 Iron preparations 9.11
9.4 Antidotes 9.14
9.4.1 Mechanism of Action of Antidotes 9.14
9.4.2 Classification of Antidotes 9.16
Questions 9.19
UNIT V
10. RADIO-PHARMACEUTICALS 10.1 − 10.18
10.1 Introduction 10.1
10.2 Radioactive isotope 10.2
10.3 Radioactive decay 10.3
10.4 Detection and measurement of radiation 10.7
10.5 Radiopharmaceuticals 10.10
10.5.1 Radioactive pharmaceutical preparations 10.12
10.5.2 Radio Opaque Contrast media 10.15
10.6 Therapeutic applications of Radiopharmaceuticals 10.16
Questions 10.18
11. IDENTIFICATION TESTS FOR ANIONS 11.1 − 11.10
Index I.1 − I.2
References R.1 − R.1
❑❑❑
 UNIT I

Chapter...1

INTRODUCTION TO
PHARMACEUTICAL INORGANIC
CHEMISTRY

♦ OVERVIEW ♦
• Pharmaceutical Chemistry
• Pharmaceutical Inorganic Chemistry
• Importance of Inorganic Pharmaceuticals
• Classification of Inorganic Pharmaceuticals

Pharmaceutical chemistry is a branch of chemistry that deals with the study of drugs,
i.e., their structure, chemical nature, composition, preparation, studies of physical and
chemical properties, method of quality control and conditions of their use. As tremendous
expansion in the knowledge about these parameters over the time, it is further subdivided
into various branches, like inorganic, organic, analytical, physical chemistry etc.
Pharmaceutical inorganic chemistry is a branch of chemistry that deals with the
chemical, biochemical, pharmacological as well as their preparation, aspects of inorganic
compounds or drugs. It includes the study of all the elements and their compounds except
carbon and its compounds (which is studied under organic chemistry). Branches of inorganic
chemistry include co-ordination chemistry, bioinorganic chemistry, organometallic
compounds and synthetic inorganic chemistry. It is a study of both essential and non-
essential elements about their preparation, standards of purity, test for identification, limit
tests to be performed for determining the quality and extent of purity, storage, different
formulations and their storage conditions and therapeutic uses.
1.1 IMPORTANCE OF INORGANIC PHARMACEUTICALS
Inorganic pharmaceuticals are useful in any of the following ways :
1. Used medicinally for various therapeutic purposes. Examples : Antacid and anti-
infectives etc.
(1.1)
Pharmaceutical Inorganic Chemistry 1.2 Introduction to Pharmaceutical Inorg. Chem.

2. Useful as pharmaceutical aids. Examples : Bentonite, talc etc.

3. To change the reaction of body fluid. To acidify or alkalis. Examples : Antacids,
alkalis, mineral acids.
4. Replacing or replenishing the normal content of body fluids. Examples : Sodium
potassium, calcium, chloride, phosphate etc.
5. Useful as reagents to carry out the reactions. Examples : Catalysts (platinum, nickel
oxidizing and reducing agents (lithium aluminium hydride).
6. Useful in Pharmaceutical analysis. Examples : Titrants such as potassium
permanganate, sodium hydroxide etc.
As these Pharmaceuticals preparations have wide range of pharmacological and
physiological applications and uses, it is very important to ensure standards and quality
specifications for medicines used. Pharmacopoeia is a legally binding collection of standards
and quality specifications for medicines used in a country or region. The detail description of
various pharmacopoeias and its contents are discussed in a later section of this chapter.

1.2 CLASSIFICATION OF INORGANIC PHARMACEUTICALS

Inorganic Pharmaceuticals can be broadly classified into two ways :
1. Based on their uses
2. Based on their application in therapy.
1.2.1 Classification Based on Their Uses
Various uses of inorganic pharmaceuticals in pharmacy are presented herein :
• Abrasives : Drugs which are used for the cleaning and whitening of teeth.
Example : Dibasic Calcium carbonate.
• Acidifiers : Drugs which are used to enhance the acidity temporarily in GIT.
Example : Dilute hydrochloric acid.
• Adsorbents : Drugs which are used in the treatment of mild dysentery or diarrhoea or
other disturbances of GIT due to their ability to adsorb gases, toxins, and bacteria.
Examples : Bismuth subcarbonate, Bismuth sub-nitrate.
• Alkalizers : Drugs which are used to induce the alkaline condition or used in acidic
condition of body. Example : Sodium citrate.
• Anaesthetics : Drugs which are used to produce reversible loss of sensation.
Example : Nitrous oxide.
• Analgesic : Drugs which are used to relieve pain. Example : Nitrous oxide.
• Antacids : These are drugs which are usually alkaline substances, used for neutralizing
excess acid in the stomach. Examples : Aluminium hydroxide gel, Magnesium carbonate.
Pharmaceutical Inorganic Chemistry 1.3 Introduction to Pharmaceutical Inorg. Chem.

• Anthelmintics : Compounds used for the treatment of worm infestations or

schistosomiasis. Examples : Ammoniated mercury, Sodium antimony tartarate.
• Antibacterial : Drugs which are used in the treatment of bacterial infections.
Example : Yellow mercuric oxide (ophthalmic).
• Anticonvulsants : Drugs which are used for the treatment of epilepsy.
Example : Potassium bromide.
• Anti-coagulants : Drugs which are used to prevent blood clotting.
Example : Sodium citrate.
• Anti-depressants : Drugs which are used in the treatment of depression.
Example : Lithium carbonate.
• Antidotes : Drugs which are used in the treatment of poison.
Examples : Sodium nitrite, Sodium thiosulphate.
• Antifebriles : Drugs which are used to relieve pain or reduce fever.
Example : Ammonium acetate.
• Antifungal agents : Drugs which are used in the treatment of fungal infections.
Examples : Zinc undecylenate (topical use), Potassium iodide.
• Antihypercalcemic agents : Drugs which are used in the treatment of abnormal calcium
concentration in the body. Example : Sodium acid phosphate.
• Anti-infectives : Drugs which are used in the treatment of local infections.
Examples : Potassium permanganate, Silver nitrate, Hydrogen peroxide, Boric acid.
• Anti-inflammatory agents : Drugs which are used in the treatment of inflammatory
pain (Rheumatoid arthritis). Example : Sodium aurothiomalate.
• Anti-irritant agents : Drugs which are used to prevent irritation or allergic reactions.
Example : Aluminium metal powder.
• Antiseptics : Drugs which are used to inhibit the growth and development of micro-
organism without killing. Example : Strong iodine solution.
• Anti-perspirants : Drugs which are used to remove the bad odour from body.
Example : Aluminium sulphate.
• Anti-protozoals : Drugs which are used in the treatment of protozoal infections or
Leishmaniasis. Example : Sodium antimony gluconate.
• Anti-pruritics (topical) : Drugs which are used in the production of soothing effect in
the skin. Example : Calamine.
• Anti-rheumatics : Drugs which are used in the treatment of rheumatism.
Example : Sodium aurothiomalate.
Pharmaceutical Inorganic Chemistry 1.4 Introduction to Pharmaceutical Inorg. Chem.

• Anti-thyroids : Drugs which are used in the treatment of thyrotoxicosis.

Example : Potassium perchlorate.
• Anti-tumor agents : Drugs which are used in the treatment of cancer.
Example : Cisplatin (Testicular and ovarian cancer).
• Anti-schistosomal agents : Drugs which are used in the treatment of schistosomiasis.
Example : Sodium antimony tartrate.
• Antioxidants : Substances that prevents or delays oxidation. Some formulations,
vegetable oils and prepared foods contain antioxidants.
Examples : Sodium bisulphate, sodium metabisulphite, sodium sulphite.
• Astringents : These are the substances which bring about protein precipitation.
Astringent action is evidenced by contraction and wrinkling of tissue.
Examples : Calamine, Aluminium citrate.
• Bactericides : Drugs which are used to kill bacteria. Example : Potassium permanganate.
• Bacteriostatics : Drugs which are used to prevent the growth of bacteria.
Examples : Alum, borax (local bacteriostatic).
• Bleaching agents : Drugs which are used in the cleansing of wounds or bleaching.
Example : Chlorinated lime.
• Buffers : Substance which prevents the change in pH upon addition of acid or base.
Examples : Acetate buffer (pH – 3.9), Sodium citrate buffer.
• Calcium supplements : Drugs which are used as a calcium source. Examples : Calcium
lactate, Calcium gluconate.
• Cathartics : Drugs which are used to enhance defecation, removes constipation and
expulsion of intestinal parasites. Example : Magnesium sulphate.
• Dentifrices : Drugs which are used in cleaning the surface of the teeth.
Example : Calcium carbonate.
• Depilatory agents : Drugs which are used to remove hair.
Example : Calcium thioglycolate.
• Diagnostic agents : Drugs which are used in diagnose the diseased conditions of the
organs. Example : Barium sulphate.
• Diaphoretics : Drugs which are used to promote sweating. Example : Potassium citrate.
• Disinfectants : Drugs which are used to kill the microbes in non-living things.
Example : Chlorinated lime.
• Diuretics : Drugs which are used to increase the urine output.
Examples : Ammonium chloride, Ammonium iodide.
• Dressing material : Substances which are used for the dressing of burns.
Example : Aluminum metal foil.
• Dusting powders : Substances which are used to have soothing effect on the skin.
Examples : Talc, Zinc stearate, Light kaolin.
Pharmaceutical Inorganic Chemistry 1.5 Introduction to Pharmaceutical Inorg. Chem.

• Electrolyte replenishers : Compounds used to treat acid base imbalance conditions in

the body.
Examples : Sodium chloride, Ringer lactate solution, Potassium chloride.
• Emetics : Drugs which are used to induce vomiting.
Examples : Zinc sulphate, Copper sulphate.
• Expectorants : Drugs which are used in the treatment of cough. They promotes the
ejection of mucous (sputum) from the lungs, bronchi and trachea by increasing its
fluidity (reducing viscosity).
Examples : Potassium iodide (sedative expectorant), Eucalyptus, Lemon (stimulant
expectorant), Ammonium chloride, Potassium iodide.
• Fillers : Drugs which are used to fill the dental cavities.
Examples : Gold and Silver metals.
• General anaesthetics : Drugs which are used to produce reversible loss of sensation.
Example : Nitrous oxide.
• Germicides : Drugs which are used to kill the germs.
Examples : Chlorinated lime, hydrogen peroxide.
• Haematinics : Drugs which are used in the treatment of anaemia.
Examples : Ferrous sulphate, Ferric ammonium citrate and other iron compounds.
• Haemostatic : Drugs which are used to arrest the flow of blood.
Example : Alum.
• Inhalants : Inhalants are the drugs or chemicals which in the vapour form are inhaled or
administered through the respiratory system in the body.
Examples : Oxygen, CO2, Ammonium carbonate, Nitrous oxide, Helium.
• Iodine supplements : Drugs which are used in the treatment of iodine deficiency.
Example : Potassium iodide.
• Laxatives : Drugs which are used to promote the evacuation of bowel.
Examples : Magnesium sulphate, Sodium phosphate.
• Chlorine source : Substance which liberates chlorine.
Examples : Chlorinated lime, Chlorinated soda.
• Protectives : Substance which tend to form a coating and protect the exposed skin or
mucous membrane from harmful stimuli.
Examples : Zinc stearate, Zinc oxide.
• Purgatives : Drugs which are used to defecate. These agents relieve constipation and
helps in the expulsion of intestinal parasites.
Example : Magnesium sulphate.
• Radiation shields : Compounds which are used to prevent the entry of radiations.
Examples : Lead sheets, Wall lining.
• Radio isotope tracers : Radioactive element or compound added to material to monitor
the material's distribution as it progresses through a system.
Examples : Carbon-14, Tritium.
Pharmaceutical Inorganic Chemistry 1.6 Introduction to Pharmaceutical Inorg. Chem.

• Radiotherapeutic agents : Radioisotopes used for the treatment of diseases.

Examples : Iodine-121, Cr-52 and Gold-198.
• Rubifacients : Substances which causes reddening of skin by dilating blood vessels and
increasing blood circulation in the applied area.
Example : Ammonia.
• Scabicides : Drugs which are used in the treatment of scabies.
Example : Sulphur.
• Sedatives : Substance which causes CNS depression and produces sedation. At higher
dose they produce sleep.
Examples : Potassium bromide, Lithium carbonate.
1.2.2 Classification Based on Their Applications
(Therapeutic classification)
Various uses of inorganic pharmaceuticals in pharmacy are presented herein :
• Acidosis : Acidosis is a pathologic condition resulting from accumulation of acid and
hydrogen ions. Inorganic drugs used in this condition are all electrolyte replenishers like
sodium chloride, potassium chloride and others.
• Acne : Acne is a very common chronic inflammatory dermatosis in adolescent in both
sexes. The lesions are seen on face, upper chest and upper back. Inorganic drugs used in
this condition are sulphur and its compounds.
• Alkalosis : Alkalosis is a pathologic condition resulting from accumulation of base and
characterized by decrease in hydrogen ion concentration. Inorganic drugs used in this
condition are all acidic electrolyte replenishers like sodium chloride, potassium chloride.
• Allergic diseases : Allergic disease is a state of hypersensitivity induced by exposure to a
particular antigen (allergen) resulting from immunologic reaction. An inorganic drug
used in this condition is magnesium thiosulphate.
• Anaemia : Anaemia is defined as decreased hemoglobin concentration in blood below
the lower limit of the normal range of individual. Inorganic drugs used in this condition
are, all iron compounds (Haematinics : Ferrous sulphate, Ferrous gluconate, Ferric
ammonium citrate etc.).
• Anoxia : It is a condition characterized by an absence of oxygen supply to an organ or a
tissue. Oxygen is used in this condition.
• Arthritis : It is a chronic systemic disease manifested as inflammation of peripheral joints
and hematological, pulmonary, cardiovascular and neurological abnormalities. Inorganic
drug used in this condition is sodium aurothiomalate.
• Asphyxia : A condition in which extreme decrease in the concentration of oxygen in the
body accompanied with increase in the concentration of carbon dioxide level leads to
unconscious or death. Oxygen is used in this condition.
• Athlete’s foot (Tinea pedis) : It is a superficial fungal infection of stratum corneum of
skin, located in the web spaces between toes. Inorganic drugs used in this condition are
sodium pyrophosphate.
 Pharmaceutical Inorganic Chemistry

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