Last Updated on October 7, 2024 by The Health Master

IP Addendum 2024

On January 7, 2024, the Indian Pharmacopoeia Commission (IPC) has introduced the Addendum 2024 to the Indian Pharmacopoeia (IP) 2012. Contents of Addendum 2024 are as under:

New Additions New General Chapters & General Monographs (N=10)

o Guidelines on the Bacterial Endotoxins Tests (2.2.33)
o Particle Size Analysis by Laser Light Diffraction (2.5.12)
o Particle Size Analysis by Dynamic Light Scattering (2.5.13.)
o Extraction and Purification Techniques of Phytoconstituents (2.6.10)
o Phytoconstituents Enrichment Process (2.6.11)
o Evaluation of Safety of Veterinary Vaccines and Immunosera (2.7.17)
o Healthy Chicken Flocks for the Production of Inactivated Vaccines for Veterinary Use (2.7.18)
o Management of Extraneous Agents in Immunological Veterinary Medicinal Products (2.7.19)
o Substitution of in-vivo Method (s) by in-vitro Method (s) for the Quality Control of Vaccines (2.7.20)
o Premixes (Veterinary General Monograph)

New Monographs (N=75)

Pharmaceuticals (N=51)

o Aceclofenac and Paracetamol Tablets
o Amlodipine and Olmesartan Medoxomil Tablets
o Atropine Ophthalmic Solution
o Azacitidine for Injection
o Azilsartan Kamedoxomil
o Azilsartan Tablets
o Bilastine
o Bilastine Tablets
o Bisoprolol Tablets
o Brivaracetam Injection

o Brivaracetam Oral Solution
o Cabozantinib S-malate
o Cabozantinib Tablets
o Cellulose Acetate
o Copovidone
o Dasatinib
o Dasatinib Tablets
o Etophylline
o Gliclazide Prolonged-release Tablets
o Ibuprofen Oral Suspension

o Itraconazole Capsules
o Itraconazole Capsules (Supra Bioavailable Formulation)
o Lactulose Concentrate
o Lactulose Solution
o Lenalidomide
o Lenalidomide Capsules
o Lindane Lotion
o Mefenamic Acid Suspension
o Miltefosine
o Miltefosine Capsule

o Molnupiravir
o Molnupiravir Capsules
o Moxifloxacin Tablets
o Nepafenac
o Nepafenac Ophthalmic Suspension
o Pantoprazole for Injection
o Paracetamol and Tramadol Tablets
o Perampanel
o Perampanel Tablets
o Remogliflozin Etabonate

o Remogliflozin Tablets
o Rifaximin
o Rifaximin Tablets
o Saline Nasal Solution
o Sodium Bicarbonate Tablets
o Sofosbuvir and Velpatasvir Tablets
o Thalidomide
o Thalidomide Capsules
o Tobramycin Sulphate
o Velpatasvir
o Vildagliptin Prolonged-release Tablets

Phytopharmaceuticals (N=3)

o Glycyrrhiza glabra PPI
o Justicia adhatoda PPI
o Zingiber officinale PPI

Biotechnology Derived Therapeutic Products (N=1)

o Pegfilgrastim Injection

Veterinary Pharmaceuticals (N=20)

o Aspirin Tablets/Boluses
o Carboprost Tromethamine
o Carboprost Tromethamine Injection
o Carprofen Tablets
o Cephapirin Benzathine
o Cephapirin Benzathine Intramammary Infusion
o Clopidogrel Bisulphate
o Flunixin Meglumine Injection
o Ketamine Hydrochloride
o Ketamine Injection

o Pimobendan
o Pimobendan Capsules
o Propofol
o Profofol Injection
o Quiniodochlor
o Selamectin
o Tilmicosin
o Tilmicosin Phosphate
o Tilmicosin Injection
o Triclabendazole

Revisions and Upgradations

General Chapters & General Monographs (N=21)

o Effectiveness of Antimicrobial Preservatives (2.2.2)
o Microbial Contamination in Nonsterile Products (2.2.9)
o Test for Biological Reactivity, In Vivo (2.2.24)
o Design and Development of Biological Assay and its Validation (2.2.31)
o Atomic Absorption Spectrometry (2.4.2)
o Gas Chromatography (2.4.13)
o Liquid Chromatography (2.4.14)
o Solubility (2.4.26)
o Characterisation of Crystalline and Partially Crystalline Solids by X-ray Powder Diffraction (XRPD) (2.4.43)
o Dissolution Test (2.5.2)

o Friability of Uncoated Tablets (2.5.5)
o Particle Size Distribution Estimation (2.5.7)
o Opitical Microscopy (2.5.8)
o Test for Absence of Non-Avian Mycoplasmas and Ureaplasmas (2.7.8)
o Test for Absence of Avian Mycoplasma in Live Viral Poultry Vaccines (2.7.9)
o Infra-red Reference Spectra (3.1)
o Thin Layer Chromatography (3.2.1)
o High Performance Liquid/ Gas/ NMR Chromatogram of Phytopharmaceuticals (3.3.1)
o General Reagents (4.2)
o Standard Solutions (4.4)
o Capsules (General Monograph)

Monographs (N=220)

Chemicals (N=158)

o Abacavir Sulphate
o Alprazolam
o Alprazolam Prolonged-release Tablets
o Amiodarone Hydrochloride
o Amiodarone Intravenous Infusion
o Amiodarone Tablets
o Artesunate Injection
o Atenolol
o Atenolol Tablets
o Benzyl Alcohol

o Bromhexine Tablets
o Buprenorphine Hydrochloride
o Buprenorphine Injection
o Carboxymethylcellulose Eye Drops
o Cefepime Hydrochloride
o Cefepime Injection
o Cefixime Dispersible Tablets
o Chlorothiazide
o Chlorothiazide Tablets
o Chlorpropamide

o Chlorpropamide Tablets
o Chlorthalidone
o Cilostazol
o Clindamycin Hydrochloride
o Clindamycin Capsules
o Clopidogrel Bisulphate
o Codeine Phosphate
o Colchicine and Probenecid Tablets
o Crospovidone
o Cyclobenzaprine Hydrochloride

o Cyclobenzaprine Tablets
o Dexamethasone Tablets
o Dexamethasone Sodium Phosphate
o Dextrose
o Doxycycline Hydrochloride
o Doxycycline Capsules
o Doxycycline Dispersible Tablets
o Drotaverine Tablets
o Dutasteride Capsules
o Dydrogesterone

o Dydrogesterone Tablets
o Erythromycin Gastro-resistant Tablets
o Esomeprazole Gastro-resistant Tablets
o Ethanol
o Ethyl Paraben
o Fasudil Hydrochloride
o Fluphenazine Decanoate Injection
o Flurazepam Capsules
o Flurbiprofen
o Flurbiprofen Tablets

o Flutamide
o Fosinopril Sodium Tablets
o Frovatriptan Succinate
o Fusidic Acid
o Gemcitabine Injection
o Glibenclamide Tablets
o Glibenclamide and Metformin Tablets
o Hydroxypropylmethylcellulose
o Imipenem and Cilastatin Injection
o Anhydrous Lactose

o Lactulose
o Leflunomide
o Levamisole Tablets
o Losartan Potassium
o Losartan Tablets
o Liquid Maltitol
o Mefenamic Acid Capsules
o Mercaptopurine
o Mercaptopurine Tablets
o Meropenem

o Meropenem Injection
o Metformin Hydrochloride
o Metformin Hydrochloride Prolonged-release Tablets
o Metformin Tablets
o Methylparaben
o Methyl Salicylate
o Metoprolol Succinate Prolonged-release Tablets
o Metronidazole
o Metronidazole Injection
o Metronidazole Gel

o Metronidazole Tablets
o Mexiletine Hydrochloride
o Mianserin Tablets
o Miconazole Nitrate
o Montelukast and Levocetirizine Tablets
o Morphine Sulphate
o Mustine Hydrochloride
o Neomycin Sulphate
o Neomycin Eye Drops
o Neomycin Eye Ointment

o Neostigmine Bromide
o Neostigmine Tablets
o Nortriptyline Hydrochloride
o Nystatin
o Ofloxacin
o Ofloxacin Tablets
o Oleic Acid
o Olmesartan Medoxomil
o Olmesartan Medoxomil Tablets
o Olmesartan Medoxomil and Hydrochlorothiazide Tablets

o Ondansetron Hydrochloride
o Ondansetron Injection
o Ondansetron Oral Solution
o Ondansetron Tablets
o Pantoprazole Sodium
o Pantoprazole Gastro-resistant Tablets
o Pioglitazone Hydrochloride
o Pioglitazone Tablets
o Poloxamers
o Polymyxin B Sulphate

o Prednisolone Tablets
o Pregabalin
o Primaquine Phosphate
o Primaquine Tablets
o Propylparaben
o Pyrimethamine and Sulphadoxine Tablets
o Quiniodochlor
o Rabeprazole Sodium
o Rabeprazole Gastro-resistant Tablets
o Repaglinide Tablets

o Repaglinide and Metformin Tablets
o Reserpine Tablets
o Ribavirin
o Salbutamol Syrup
o Saquinavir Capsules
o Secnidazole
o Sitagliptin Tablets
o Sodium Benzoate
o Sodium Fusidate
o Sodium Lactate Injection

o Sodium Nitroprusside Injection
o Sodium Valproate Gastro-resistant Tablets
o Spironolactone
o Spironolactone Tablets
o Stearyl Alcohol
o Sucrose
o Teicoplanin Injection
o Telmisartan
o Telmisartan Tablets
o Terbutaline Sulphate

o Terbutaline Inhalation
o Terbutaline Injection
o Terbutaline Tablets
o Tinidazole Tablets
o Trandolapril Tablets
o Tranilast
o Trimethoprim and Sulphamethoxazole Oral Suspension
o Valganciclovir Hydrochloride
o Valganciclovir Tablets
o Valsartan

o Valsartan Tablets
o Venlafaxine Prolonged-release Capsules
o Venlafaxine Prolonged-release Tablets
o Venlafaxine Tablets
o Sterile Water for Injections
o Zinc Undecenoate Ointment
o Zoledronic Acid
o Zuclopenthixol Decanoate Injection

Vitamins, Minerals, Amino Acids, Fatty Acids etc. (N=22)

o Water-Soluble Vitamins Capsules
o Water-Soluble Vitamins Tablets
o Ascorbic Acid
o Ascorbic Acid Injection
o Calcium Carbonate Tablets
o Tribasic Calcium Phosphate
o Cholecalciferol Tablets
o Chromium Picolinate
o Cyanocobalamin
o Folic Acid

o Folic Acid Tablets
o Heavy Magnesium Carbonate
o Light Magnesium Carbonate
o Heavy Magnesium Oxide
o Light Magnesium Oxide
o Magnesium Sulphate
o Methylcobalamin
o Nicotinamide
o D-Panthenol
o Pyridoxine Tablets
o Riboflavin
o Riboflavin Sodium Phosphate

Phytopharmaceuticals (N=1)

o Aegle marmelos PPI

Vaccines and Immunosera for Human Use: General Requirements (N=4)

o Vaccines
o Antisera
o Measles, Mumps and Rubella Vaccine (Live)
o Mumps Vaccine (Live)

Blood and Blood Related Products (N=6)

o Anti- B Blood Grouping Serum
o Anti -AB Blood Grouping Reagent
o Antithrombin III Concentrate
o Blood Grouping Lectins Anti-H
o Human Albumin
o Human Normal Immunoglobulin for Intravenous use

Biotechnology Derived Therapeutic Products (N=5)

o Erythropoietin Concentrated Solution
o Pegfilgrastim
o Recombinant Streptokinase for Injection
o Rituximab
o Rituximab Injection

Veterinary Vaccines (N=5)

o Blackquarter Vaccine
o Brucellaabortus (Strain 19) Vaccine, Live
o Canine Adenovirus Vaccine (Live)
o Canine Leptospirosis Vaccine, Inactivated
o Haemorrhagic Septicaemia Vaccine, Inactivated

Veterinary Pharmaceuticals (N=16)

o Veterinary Vaccine General Requirements
o Veterinary Liquid Preparation for Cutaneous Application
o Deltamethrin Pour-on
o Ivermectin
o Ivermectin Injection
o Veterinary Oral Liquids
o Veterinary Oral Powders
o Veterinary Tablets and Boluses
o Buparvaquone
o Buparvaquone Injection
o Cefoperazone Sodium Intramammary Suspension
o Ivermectin Pour-on
o Progesterone
o Progesterone Injection
o Rafoxanide
o Trimethoprim and Sulphamethoxazole Injection

Change in Title (N=3)

o Change from: Glyceryl Trinitrate Tablets
o Change to: Glyceryl Trinitrate Sublingual Tablets
o Change from: Particle Size Distribution (2.5.7)
o Change to: Particle Size Distribution Estimation by Analytical Sieving (2.5.7)
o Change from: Optical Microscopy: Particle Size by Microscopy (2.5.8)
o Change to: Optical Microscopy (2.5.8)

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