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Indian Pharmacopoeia 2018 Overview

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0% found this document useful (0 votes)
158 views9 pages

Indian Pharmacopoeia 2018 Overview

Uploaded by

Umang Barot
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd

IP 2018 INTRODUCTION

Introduction
Introduction requirements. Some chapters such as Dimension of Hard
Cellulose Capsule Shells, Hard Gelatin Capsule Shells, Taste
The eighth edition of the Indian Pharmacopoeia (IP 2018) is and Odour, Granules, Approximate pH of Solutions, Monocyte
published by the Indian Pharmacopoeia Commission (IPC) in activation test, Microbiological assay of vitamin B 12 activity,
accordance with a designed plan by the Scientific Body of Microbiological assay of calcium pantothenate, Test for
IPC, in fulfilment of the requirements of the Drugs and biological reactivity, in vivo as well as in vitro, Botanical Extract
Cosmetics Act 1940 and Rules thereunder and completed and Viral safety evaluation of biotechnology products derived
through the untiring efforts of its members, Secretariat and from cell lines of Human or Animal origin are newly included
Laboratory over a period of about two years. It supersedes as per the technological requirements.
the IP 2014 edition but any monograph of the earlier edition
that does not figure in this edition continues to be official as Format
stipulated in the Second Schedule of the Drugs and Cosmetics
Act, 1940. In an effort to make the pharmacopoeia more user-friendly, the
design of the texts of the monographs and test methods are
Presentation kept same. Cross-referencing has been avoided to make each
monograph complete in itself, thus making it convenient to
The Indian Pharmacopoeia 2018 is presented in four volumes. the user.
Volume I contains the Notices, Preface, the Structure of the
IPC, Acknowledgements, Introduction and the General Pharmacopoeial Requirements
Chapters. Volume II contains the General Notices, General As in the past, this compendium provides a publicly available
Monographs on dosage forms, Monographs on drug statement concerning the quality of a product that can be
substances, dosage forms and pharmaceutical aids (A to M). expected and demonstrated at any time throughout the
Volume III contains Monographs on drug substances, dosage accepted shelf-life of the article. The standards laid down
forms and pharmaceutical aids (N to Z) followed by and represent the minimum with which the article must comply
distinguished by colour codes, Monographs on Vaccines and
and it is for the manufacturer to ensure that the article is
Immunosera for human use, Herbs and herbal products, Blood
manufactured in accordance with Good Manufacturing
and blood-related products, Biotechnology Derived
Practices (GMPs). It is essential that sufficiently stringent
Therapeutic products, Allergen products and Radio-
limits are applied at the time of release of a batch of drug
pharmaceutical preparations, Volume IV contains Veterinary
substance or drug product so that the pharmacopoeial
monographs and Index.
standards are met until its expiry when stored under the storage
The scope of the Indian Pharmacopoeia has been extended to conditions specified.
include products of biotechnology, herbs and herbal products, It must be noted that a valid interpretation of any requirement
veterinary vaccines and additional antiretroviral drugs and of the Indian Pharmacopoeia should be done in the context of
formulations, inclusive of commonly used fixed-dose the monograph as a whole, the relevant general monographs,
combinations. Standards for new drugs and drugs used under where appropriate, the specified tests and methods of analysis
National Health Programmes and included in National List of including any reference to the relevant General Notices.
Essential Medicines are added and the drugs as well as their Familiarity with the General Notices will facilitate the correct
formulations currently not used are omitted from this edition. application of the requirements.
The number of monographs of Drugs substances, Dosage
forms, Excipients, Vaccines and Immunosera for Human use, Changes
Herbs and Herbal Products, Blood and Blood related products
and Biotechnology Derived Therapeutic products have been Keeping in view the essential requirement under the Drugs
increased in this edition. Monographs of Vaccines and and Cosmetics Act, 1940 and Rules thereunder, the information
Immunosera for Human use are also upgraded in view of the on the category of a drug, and available usual strengths of
latest development of the technology in the field. Many general dosage forms has been kept in this edition.
chapters such as Tablets, Capsules, Volumetric Glassware and General chemical tests for identification of an article have been
Maintenance, Identification, Preservation and Disposal of almost eliminated and more specific infrared, ultraviolet
Microorganism have been revised. The monographs on spectrophotometric and HPLC tests have been given
General Chapters such as Disintegration, Dissolution are also emphasis. The concept of relying on published infrared spectra
upgraded to harmonise with prevailing international as a basis for identification has been continued.

xxiii
INTRODUCTION IP 2018

The use of chromatographic methods has been greatly pertaining to the quality requirements of medicinal substances.
extended to cope up with the need for the specificity in assays It also includes reference data such as reference spectra,
and in particular, in assessing the nature and extent of typical chromatograms etc. The test methods reflect the
impurities in drug substances and drug products. Most of the sophistication of analytical methodology and instrumentation.
existing assays and related substances tests have been
Analytical methods in general are in harmony with those
upgraded to liquid chromatography method in view to have
adopted internationally for monitoring the quality of drugs.
the specificity and to harmonise with other International
The steps taken for harmonization have been initiated by the
Pharmacopoeias to the extent necessary. The up-gradation in
need to cope with the increasing demand for drugs
this edition covers all the amendments and errata released
manufactured in the country to meet globally accepted
after publication of Addendum 2016 to IP-2014.
standards.
In most of the parenteral preparation and other monographs,
the test for pyrogens involving the use of animals has been Accordingly 10 new chapters have been introduced based on
almost eliminated and replaced with Bacterial Endotoxin test. current technologies used by the stakeholders and harmonized
In some blood and blood related monographs, the Bacterial with other international pharmacopoieas; like Dimensions of
Endotoxin test has been incorporated. The test for Biological Hard Cellulose Capsule Shells, Monocyte Activation Test,
Reactivity, in vivo. Test for Biological reactivity, in vitro Granules and Odour and Taste etc.
Microbiological Assay of Vitamin B 12 activity and The trend towards controlling the microbial quality of all
Microbiological Assay of Calcium Pantothenate has been medicinal products has been recognized and the requirement
added. regarding limits of microbial contamination, even of products
More essential oils monographs, crude herbal drugs and for oral administration and topical application, so that
extracts have been incorporated and also some existing adequate controls are exercised by the manufacturers by the
monographs have been revised under the section Herbs and adoption of GMPs has been continued.
Herbal Products in volume III. General Chapter on Maintenance, identification, preservation
Three monographs on radiopharmaceutical preparations, 10 and disposal of micro-organisms has been revised and a
monographs on Blood and Blood related products, 06 general chapter on Viral safety evaluation of biotechnology
monographs on Biotechnology Derived Therapeutic products, products derived from cell lines of Human or Animal origin
02 new monograph on Vaccines and Immunosera for Human has been included for the first time.
use and 15 monographs on Herbs and Herbal products have In the Herbs and Herbal products section, general chapter on
been added in Volume III of this edition. Botanical Extract has been revised.
A separate volume for veterinary monographs as Volume IV of
this edition of Indian Pharmacopoeia has been designed to Monographs
provide comprehensive information to those concerned with
The General Monographs for dosage forms of active
the quality control of veterinary medicines. 14 new veterinary
pharmaceutical ingredients (APIs) are grouped together at
monographs have been added in this volume. Several
the beginning of Volume II. They are followed by the
monographs on chemicals along with a number of monographs
monographs for the APIs, pharmaceutical aids and individual
on veterinary vaccines, diagnostic, immunosera and surgical
dosage forms, all in alphabetical order upto Volume III.
materials have been given place in this volume. Many
Monographs for other articles of special nature such as
monographs just on the basis of usual strengths and doses
vaccines and immunosera for human use, herbs and herbal
have been mentioned in this volume while complete
products, blood and blood related products, biotechnology
monographs are mentioned in other volumes of IP.
derived therapeutic products and radiopharmaceuticals
The monograph on Brucella Melitensis (Strain Rev.1) Vaccine, preparations are given in separate sections in Volume III.
Live; Canine Adenovirus Vaccine, Inactivated; Canine Special emphasis has been given to veterinary monographs
adenovirus vaccine, Live; Canine Contagious Hepatitis adding new ones and updating the existing monographs in
Vaccine, Live; Old Adjuvant Vaccine Against Pasturellosis in volume IV.
sheep and Goats & Rinderpest Vaccine, Live have been
omitted. Any necessary corrections have been incorporated A list of 220 new monographs included in the 2018 edition of
in this edition. the Indian Pharmacopoeia, is given below:

General Chapters Admissions


Volume I is devoted mainly to test methods that are applicable General Chapters
to all the articles of the pharmacopoeia and general information 2.2.23. Test for Biological Reactivity, In Vitro

xxiv
IP 2018 INTRODUCTION

2.2.24. Test for Biological Reactivity, In Carmustine Enalapril Maleate and


Vivo Carmustine Injection Hydrochlorothiazide Tablets
2.2.25. Monocyte Activation Test Cefdinir Escitalopram Oxalate and Clonazepam
2.2.26 . Microbiological Assay of Tablets
Cefdinir Oral Suspension
Calcium Pantothenate Esmolol Injection
Cefixime Dispersible Tablets
2.2.27. Microbiological Assay of Vitamin Etodolac Prolonged-release Tablets
Cefuroxime Axetil and Potassium
B12 Activity Folic Acid and Methylcobalamin
Clavulanate Tablets
2.4.45. Odour and Taste Tablets
Cholecalciferol Concentrate (Powder
5.8.2. Dimensions of Hard Cellulose Form) Ganciclovir
Capsule Shells Cilnidipine Ganciclovir Injection
2.2.28. Viral Safety Evaluation of Cilnidipine Tablets Ganciclovir Oral Suspension
Biotechnology products derived Glibenclamide and Metformin Tablets
Cinacalcet Hydrochloride
from cell lines of Human or Glycopyrrolate
Animal origin Clindamycin Palmitate Hydrochloride
Glycopyrrolate Injection
2.4.46. Approximate pH of Solutions Clindamycin Palmitate Hydrochloride
Oral Suspension Glycopyrrolate Tablets
Granules (General Monographs for
Clonidine Hydrochloride Hydroxyurea
Dosage Forms)
and Chlorthalidone Tablets Hydroxyurea Capsules
Monographs on drug substances, dosage Cyclobenzaprine Hydrochloride Ibuprofen and Paracetamol Tablets
forms and pharmaceutical aids
Cyclobenzaprine Tablets Ibuprofen and Pseudoephedrine
Abiraterone Acetate Tablets Hydrochloride Tablets
Dacarbazine
Aluminium, Magnesium and Isoflurane
Simethicone Chewable Tablets Dacarbazine Injection
Isotretinoin Gel
Aluminium, Magnesium and Daclatasvir Dihydrochloride
Latanoprost Eye Drops
Simethicone Oral Suspension Dapoxetine Tablets
Ambrisentan Latanoprost and Timolol Ophthalmic
S-Dapoxetine Hydrochloride Solution
Ambrisentan Tablets
S-Dapoxetine Tablets Letrozole
Amiloride and Hydrochlorothiazide
Dapsone Gel Letrozole Tablets
Tablets
Amlodipine and Benazepril Darifenacin Hydrobromide Levetiracetam Tablets
Hydrochloride Capsules Darifenacin Prolonged-release Tablets Levodopa and Carbidopa Prolonged-
Aprepitant Darunavir Ethanolate release Tablets
Aprepitant Capsules Darunavir Tablets Levofloxacin Oral Solution
Armodafinil Lignocaine
Diclofenac Diethylamine
Artesunate Injection Lignocaine and Prilocaine Cream
Diclofenac Sodium and Paracetamol
Atenolol and Chlorthalidone Tablets Tablets Lignocaine Hydrochloride Topical
Atorvastatin and Fenofibrate Tablets Solution
Diclofenac Gel
Azelnidipine Tablets Lignocaine Oral Topical Solution
Diethylene Glycol Monoethyl Ether
Bisoprolol Fumarate Lorcaserin Hydrochloride Hemihydrate
Dinoprostone
Bisoprolol Fumarate and Lorcaserin Tablets
Hydrochlorothiazide Tablets Dinoprostone Oral Solution
Magaldrate and Simethicone Chewable
Bosentan Monohydrate Diphenoxylate Hydrochloride and Tablets
Bosentan Tablets Atropine Sulphate Tablets Magaldrate and Simethicone Oral
Calcium and Vitamin D3 Tablets Dopamine Hydrochloride and Dextrose Suspension
Injection Mefenamic Acid and Dicyclomine
Captopril and Hydrochlorothiazide
Tablets Dothiepin Tablets Hydrochloride Tablets

xxv
INTRODUCTION IP 2018

Memantine Hydrochloride Oxymetazoline Hydrochloride Nasal Telmisartan and Hydrochlorothiazide


Memantine Tablets Solution Tablets
Oxymetazoline Hydrochloride Terbinafine Hydrochloride
Mesna
Paliperidone Terbinafine Cream
Metadoxine
Pantoprazole Gastro-resistant and Terbinafine Tablets
Metformin Hydrochloride Prolonged-
Domperidone Prolonged-release Thioguanine
release and Glimepiride Tablets
Capsules
Thioguanine Tablets
Methylcobalamin
Paracetamol and Caffeine Tablets
Ticagrelor
Methyldopa and Hydrochlorothiazide Paroxetine Hydrochloride Hemihydrate
Tablets Tobramycin and Fluorometholone
Phenylephrine Eye Drops Acetate Ophthalmic Suspension
Metoprolol Succinate Prolonged-
release and Amlodipine Besilate Phenylephrine Hydrochloride and Tobramycin Inhalation Solution
Tablets Chlorpheniramine Maleate Drops Trimetazidine Tablets
Metoprolol Tartrate and Phenylephrine Hydrochloride and Trospium Chloride Tablets
Hydrochlorothiazide Tablets Chlorpheniramine Maleate Syrup
Voriconazole Injection
Phytomenadione
Montelukast Granules Xylometazoline Hydrochloride and
Phytomenadione Injection Sorbitol Nasal Drops
Montelukast Sodium and
Levocetirizine Hydrochloride Tablets Piperacillin and Tazobactam Injection Zolpidem Tartrate Prolonged-release
Mycophenolate Mofetil Oral Piroxicam Tablets Tablets
Suspension Pregabalin and Methylcobalamin Zonisamide Capsules
Mycophenolate Mofetil Tablets Capsules
Antibiotic
Nadifloxacin Prilocaine
Gentamicin Cream
Nadifloxacin Cream Procarbazine Hydrochloride Capsules
Gentamicin Ointment
Propylene Glycol Monocaprylate
Nadifloxacin Gel
Quinapril Hydrochloride Radiopharmaceutical
Nitroglycerin Injection
Quinapril and Hydrochlorothiazide Gallium (68 Ga) Chloride solution for
Norethisterone and Ethinyl Estradiol
Tablets Radiolabelling
Tablets
Repaglinide and Metformin Tablets Sodium Iodide (123 I) Injection (From 124
Norgestimate Xe)
Risedronate Sodium Tablets
Norgestimate and Ethinyl Oestradiol Sodium Iodide ( 123 I) Solution for
Tablets Ropivacaine Hydrochloride
Radiolabelling
Ofloxacin and Ornidazole Tablets Ropivacaine Injection
Rosuvastatin Calcium and Ezetimibe Herbal
Olanzapine and FluoxetineTablets
Tablets Amarbel
Olmesartan Medoxomil and
Rosuvastatin and Fenofibrate Tablets Anise Oil
Hydrochlorothiazide Tablets
Sertaconazole Nitrate Belladona Dry Extract Tablets
Omeprazole and Domperidone
Capsules Sertaconazole Nitrate and Citronella Oil (Geraniol type)
Beclomethasone Dipropionate Cream
Olopatadine Hydrochloride Citronella Oil (Java type)
Sodium Alendronate Trihydrate
Olopatadine Ophthalmic Solution Green Coffee Bean Extract
Sucralfate
Olopatadine Tablets Horse Chestnut Dry Extract
SucralfateTablets
Oxaliplatin Juniper Oil
Tamsulosin Hydrochloride Prolonged-
Oxaliplatin Injection release and Dutasteride Capsules Mandarin Oil
Oxybutynin Hydrochloride Tazobactam Milk Thistle
Oxybutynin Prolonged-release Tablets Telmisartan and Amlodipine Tablets Milk Thistle Dry Extract

xxvi
IP 2018 INTRODUCTION

Schisandra Dry Extract Cefuroxime Intramammary Infusion Pertussis and Inactivated


Cephalexin Intrauterine Powder for Poliomyelitis Vaccine
Schisandra Fruit
Suspension Adsorbed Diphtheria, Tetanus,
Sweet Orange Oil
Cephalexin Veterinary Oral Powder Pertussis, Inactivated Poliomyelitis
Tvak Vaccine and Haemophilus influenzae
Enrofloxacin Injection
Type b Conjugate Vaccine
Vaccines and Immunosera for Human Marbofloxacin Injection
Adsorbed Diphtheria, Tetanus,
Use myo-Inositol Pertussis and (Acellular Component)
Pneumococcal polysaccharide Oxytetracycline Hydrochloride Poliomyelitis (Inactivated) Vaccine.
conjugate vaccine (Adsorbed) Injection Adsorbed Diphtheria, Tetanus,
Scorpion Venom Antiserum Sodium Acid Phosphate Injection Pertussis, Poliomyelitis (Inactivated)
Biotechnology Derived Therapeutic Trimethoprim and Sulphamethoxazole and Haemophilus influenzae Type b
Products Injection Conjugate Vaccine
Allopurinol Tablets
Follicle Stimulating Hormone
Up-gradation Aluminium Hydroxide Gel
Concentrated Solution
Follicle Stimulating Hormone Injection General Chapters upgraded: Amoxycillin Capsules
Follicle Stimulating Hormone 2.1.6. Volumetric Glassware Amoxycillin Dispersible Tablets
Interferon -1a Injection 2.2.3. Bacterial Endotoxins Amoxycillin Injection
Teriparatide 2.2.15. Host Cell Proteins and Host Amoxycillin Oral Suspension
Cell DNA Amoxycillin Sodium
Teriparatide injection
2.2.20. Maintenance, Identification, Amoxycillin Trihydrate
Blood and Blood Related Products Preservation and Disposal of
Ampicillin Capsules
Microorganisms
Anti-D (IgM) monoclonal blood Ampicillin Injection
grouping reagent 2.3.9. Aluminium in Adsorbed
Vaccines Ampicillin Oral Suspension
Blood Grouping Reagent Anti-Fya,
2.3.30. Nitrogen Ampicillin Sodium
Anti-Fyb
2.4.9. Conductivity Ampicillin Trihydrate
Blood Grouping Reagent Anti-Jka,
Anti-Jkb 2.5.1. Disintegration Test Ampicillin Veterinary Oral Powder
Blood Grouping Reagent Anti-K, 2.5.2. Dissolution Test Amprolium Hydrochloride
Anti-k 5.8.1. Dimensions of Hard Gelatin Anthrax Spore Vaccine, Live
Blood Grouping Reagent Anti-M, Capsule Shells Anti-D (Rho) Immunoglobulin
Anti-N Vaccines: General Requirements Arjuna Dry Extract
Blood Grouping Reagents Anti P1 Veterinary Diagnostics Atracurium Besylate Injection
Blood Grouping Reagents Anti-Le , a Veterinary Immunosera Avian Infectious Bronchitis Vaccine,
Anti-Leb Veterinary Vaccines: General Inactivated
Blood Grouping Reagents Anti-S, Requirements
Avian Infectious Bronchitis Vaccine,
Anti-s Monographs on drug substances, dosage Live
Blood Grouping Lectins Anti-H forms and pharmaceutical aids given Avian Infectious Laryngotracheitis
Blood Grouping Lectins Anti-A1 below have been upgraded: Vaccine, Live
Abiraterone Acetate Avian Mycoplasma Antigen
Veterinary Non-biological
Acepromazine Maleate Azathioprine Tablets
Albendazole Veterinary Oral Powder
Acepromezine Injection Bacillus Calmette-Guerin Vaccine
Amoxycillin Tablets (Freeze-Dried)
Aciclovir
Amprolium Oral Powder Adrenaline Bacitracin
Buparvaquone Adrenaline Tartrate Bacitracin Zinc
Buparvaquone Injection Adsorbed Diphtheria, Tetanus, Bambuterol Hydrochloride

xxvii
INTRODUCTION IP 2018

Bambuterol Tablets Cetrimide Cream Diphtheria, Tetanus, Pertussis (Whole


Batamethasone Cream Cetrimide Emulsifying Ointment Cell), Hepatitis B (rDNA) and
Haemophilus influenzae Type b
BCG Immunotherapy Chlorthalidone Conjugate Vaccine (Adsorbed)
Bendamustine Injection Cholecalciferol Dipyridamole
Benzathine Penicillin Cholera Vaccine (Inactivated, Oral) Disopyramide Phosphate Capsules
Benzathine Penicillin Injection Clarithromycin Tablets Disopyramide Phosphate Prolonged-
Benzhexol Tablets Classical Swine Fever Vaccine, Live release Capsules
Benzyl Alcohol Divalproex Prolonged-release Tablets
Clobazam Tablets
Benzyl Benzoate Divalproex Sodium
Clobetasone Cream
Betamethasone Valerate Cream Docetaxel Anhydrous
Clomifene Citrate
Bhibhitaki Doxofylline
Clotrimazole Cream
Bifonazole Cream Doxorubicin Injection
Clotrimazole Pessaries
Biphasic Insulin Lispro Injection Duloxetine Gastro-resistant Tablets
Clonidine Tablets Egg Drop Syndrome’76 (Adenovirus)
Blackquarter Vaccine
Brimonidine Tartrate Eye Drops Closantel Sodium Dihydrate Vaccine, Inactivated
Brucella Abortus (Strain 19 Vaccine) Crospovidone Enrofloxacin
Vaccine, Live Crotaminton Enterotoxaemia Vaccine, Inactivated
Bumetamide Injection Cyclosporine Ergotamine Injection
Butylparaben Daruharidra Roots Esmolol Hydrochloride
Calcitonin (Salmon) Injection Ethacrynic Acid
Decoquinate
Calcium Folinate (Leucovorin Ca) Ethanolamine
Desferrioxamine Injection
Calcium Magnesium Borogluconate Etoposide
Dexamethasone Sodium Phosphate
Injection Fibrin Sealant Kit filgrastin
Dexamethasone Tablets concentrated solution
Calcium Stearate
Dexlansoprazole Fenspiride Hydrochloride
Canine Adenovirus Vaccine, Live
Diazoxide Finasteride
Canine Coronavirus Vaccine,
Inactivated Diclazuril Finasteride Tablets
Canine Distemper Vaccine, Live Dichlorophen Tablets Foot and Mouth Disease Vaccine,
Inactivated
Canine Infectious Contagious Diclofenac Prolonged-release Tablets
Hepatitis Vaccine, Inactivated Flucloxacillin Oral Solution
Dicloxacillin Sodium
Canine Parainfluenza Virus Vaccine, Fortified Benzathine Penicillin Injection
Diloxanide Furoate
Live Folic Acid
Diluted Pentaerythritol Tetranitrate
Canine Parvovirus Vaccine, Inactivated Fortified Procaine Penicillin Injection
Dimethicone Fosinopril Sodium
Canine Parvovirus Vaccine, Live
Dinitolamide Fowl Cholera Vaccine, Inactivated
Caprofen
Carboxymethylcellulose Sodium Diphtheria Vaccine (Absorbed) Fowl Pox Vaccine, Live
Carnauba Wax Diphtheria, Tetanus and Pertussis Fructose Injection
Vaccine (Adsorbed) Frusemide Tablets
Cefoperazone Injection
Diphtheria, Tetanus, Pertussis (Whole Furazolidone
Cefoperazone Sodium
Cell) and Haemophilus influenzae
Cefoperazone Sodium Intramammary Gabapentin Capsules
Type b Conjugate Vaccine
Suspension (Adsorbed) Gemcitabine Hydrochloride
Cefotaxime Sodium Injection Diphtheria, Tetanus, Pertussis (Whole Ginkgo Dry Extract
Cetirizine Hydrochloride Cell) and Hepatitis B (rDNA) Vaccine Ginkgo Tablets
Cefpodoxime Tablets (Adsorbed) Glibenclamide Tablets

xxviii
IP 2018 INTRODUCTION

Gliclazide Insulin Glargine Methylprednisolone


Gliclazide Tablets Insulin Glargine Injection Metolazone Tablets
Glucosamine Sulphate Sodium Ivermectin Injection Metoprolol Succinate
Chloride Ivermectin Oral Paste Metoprolol Succinate Prolonged-
Goat Pox Vaccine, Live Ivermectin Pour on release Tablets
Guggulipid Japanese Encephalitis Live Vaccine Metoprolol Tartrate
Guggulipid Tablets (Human) Metronidazole Benzoate Oral
Guggul Resin Japanese Encephalitis Vaccine Suspension
Haemorrhagic Septicaemia Vaccine, (Human) Metronidazole Injection
Inactivated Japanese Encephalitis Vaccine Mometasone Cream
Heparin Injection Inactivated (Adsorbed, Human) Mometasone Ointment
Heparin Sodium Ketorolac Tromethamine Moxidectin
Hepatitis A (Inactivated) and Hepatitis Labetalol Injection Myristic Acid
B (rDNA) Vaccine (Adsorbed) Lactic Acid Nifedipine Prologed-release Tablets
Human Albumin Latanoprost Nitroxynil Injection
Human Normal Immunoglobulin Levamisole Injection Ofloxacin
Human Normal Immunoglobulin for Levetiracetam Ofloxacin Oral Suspension
Intravenous use Levocetirizine Tablets Ofloxacin Tablets
Human Plasma Protein Fraction Levodropropizine Olmesartan Medoxomil
Hydrochlorothiazide Levofloxacin Infusion Ondansetron Hydrochloride
Hydrochlorothiazide Tablets Levofloxacin Injection Ondansetron Orally Desintegrating
Hydroxychloroquine Tablets Levonorgestrel and Ethinyloestradiol Tablets
Hydroxypropylmethyl Cellulose Tablets Oral Rehydration Salts
Hyoscine Butylbromide Levosalbutamol Sulphate Orphenadrine Citrate
Hyoscine Butylbromide Injection Liquid Maltitol Orphenadrine Hydrochloride
Hyoscine Butylbromide Tablets Marek’s Disease Vaccine, Live Oxytetracycline Hydrochloride
Hyoscine Hydrobromide Measles and Rubella Vaccine (Live) Injection
Hyoscyamine Sulphate Measles Vaccine (Live) OxytetracyclineDihydrate Injection
Ifosfamide Injection Measles, Mumps and Rubella Vaccine Oxytocin
(Live) Oxytocin Injection
Imipenem
Mebendazole Paracetamol Infusion
Inactivated Hepatitis A Vaccine
Mebendazole Tablets Paroxetine Hydrochloride
(Adsorbed)
Medroxyprogesterone Injection Pegfilgrastim
Inactivated Hepatitis B Vaccine
Menotropin for Injection Pemetrexed Injection
Inactivated Influenza Vaccine (Split
Virion) Meropenem Penicillamine Tablets
Inactivated Influenza Vaccine (Surface Mesalazine Pentobarbitone Sodium
Antigen) Mesalazine Prolonged-release Tablets Pertussis Vaccine.
Inactivated Influenza Vaccine (Whole Metformin Hydrochloride Peste Des Petits Ruminants Vaccine,
Virion) Metformin Tablets Live
Isoprenaline Methi Pethidine Injection
Isoprenaline Injection Methocarbamol Phenindione
Isopropyl Palmitate Methotrexate Phenindione Tablets
Isosorbide Dinitrate Tablets Methotrexate Tablets Phenoxyethanol
Isoxsuprine Hydrochloride Methoxamine Hydrochloride Phenylepherine Hydrochloride
Isoxsuprine Injection Methyldopa Pimozide

xxix
INTRODUCTION IP 2018

Piperacillin Tacrolimus Capsules Changed Titles of Monographs


Piperazine Citrate Tamsulosin Hydrochloride Prolonged- From Benzoyl Peroxide to Hydrous
Poliomyelitis Vaccine (Inactivated) release Capsules Benzoyl Peroxide
Poliomyelitis Vaccine, Live (Oral) Teicoplanin From Fasterodine Fumarate to
Tetanus Veterinary Vaccine Fesoterodine Fumarate
Procaine Hydrochloride
Theileriosis Vaccine, Live From Gugulipid Tablets to Gugglipid
Progesterone
Theophylline Injection Tablets
Promazine Tablets
Thiopentone Injection From ‘Gugulipid’ to ‘Guggulipid’
Promethazine Syrup
Thiopentone Sodium From ‘Labetalol’ to ‘Labetalol Injection’
Quinine Sulphate
Thymol From ‘Sulphadimidine Tablets’ to
Rabeprazole Injection ‘Sulphadimidine Bolus Tablets’
Rabies Vaccine, Human Tick-borne Encephalitis Vaccine
(Inactivated). Monographs shifted from Chemical to
Ranitidine Injection
Tolazamide Tablets Biotechnology Derived Therapeutic
Ranitidine Oral Solution Products
Triamcinolone Acetonide Injection
Ritodrine Injection
Triamcinolone Tablets Calcitonin (Salmon)
Ritonavir
Triethyl Citrate Calcitonin (Salmon) Injection
Ronidazole
Tribasic Calcium Phosphate Human Insulin
Ronidazole Veterinary Oral Powder
Triflupromazine Hydrochloride Injection Insulin Injection
Rotavirus Vaccine (Live Attenuated, Insulin Aspart
Trospium Chloride
Oral)
Tylosin Insulin Aspart Injection
Roxithromycin
Tylosin Injection Insulin Lispro
Rubella Vaccine (Live)
Tylosin Tablets Insulin Lispro Injection
Saccharin Sodium
Typhoid (Strain Ty 21a) Vaccine, Live Biphasic Insulin Aspart Injection
Salmonella Pullorum Coloured Antigen (Oral) Biphasic Insulin Lispro Injection
Salmonella Vaccine, Inactivated Typhoid Vaccine (Freeze Dried) Biphasic Isophane Insulin Injection
Somatropin Typhoid Vaccine Isophane Insulin Injection
Somatropin Concentrated Solution Typhoid Vi Conjugate Vaccine Insulin Glargine
Somatropin for Injection Typhus Vaccine Insulin Glargine Injection
Senna Dry Extract Valproic Acid
Senna Leaf Vancomycin Hydrochloride for Omissions
Senna Pods Intravenous Infusion General Monographs (Veterinary)
Senna Tablets Vancomycin Hydrochloride Dip Concentrate
Sheep Pox Vaccine, Live Attenuated Varicella Vaccine, Live Premixes
Sildenafil Citrate Vecuronium Bromide Veterinary Aerosols
Sitagliptin Phosphate Vinblastin Sulphate Teat Dips
Sodium Acetate Water for Injections in Bulk Teat Sprays
Zidovudine Udder Washes
Sodium Phosphate
Sodium Valproate Zinc Oxide and Salicylic Acid Paste Brucella Melitensis (Strain Rev. 1)
Zolmitriptan Nasal Spray Vaccine, Live
Sorbitan Oleate
Canine Adenovirus Vaccine, Inactivated
Spectinomycin Hydrochloride Zolmitriptan Tablets
Canine Adenovirus Vaccine, Live
Spectinomycin Injection
Changed Titles Canine Contagious Hepatitis Vaccine,
Spiramycin Live
Sterile Diluent for live Vaccine Changed Titles of General Chapters Old Adjuvant Vaccine Against
Sulphamethoxazole and Trimethoprim From ‘5.8 Dimension of Hard Gelatin Pasturellosis in Sheep and Goats
Bolus Capsule Shells’ to ‘5.8 Dimension of Rinderpest Vaccine, Live
Tacrolimus Capsule Shells’ Sterile Diluent for Live Vaccines

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