印度药典2010年版新特点

i IP 2010 INTRODUCTION New Features of IP 2010 This new edition of the Indian Pharmacopoeia entitled 6th edition (Indian Pharmacopoeia 2010) is published by the Indian Pharmacopoeia Commission (IPC) in accordance with a plan and completed through the untiring efforts of its members, Secretariat and Laboratory over a period of about two years. It supersedes the 2007 edition but any monograph of the earlier edition that does not figure in this edition continues to be official as stipulated in the Second Schedule of the Drugs and Cosmetics Act, 1940. Presentation The Indian Pharmacopoeia 2010 is presented in three volumes. Volume I contains the Notices, Preface, the Structure of the IPC, Acknowledgements, Introduction, and the General Chapters. Volume II contains the General Notice, General Monographs on Dosage Forms, Monographs on drug substances, dosage forms and pharmaceutical aids (A to M). Volume III contains Monographs on drug substances, dosage forms and pharmaceutical aids (N to Z) followed by Monographs on Vaccines and Immunosera for Human use, Herbs and Herbal products, Blood and blood-related products, Biotechnology products and Veterinary products. The scope of the Pharmacopoeia has been extended to include products of biotechnology, indigenous herbs and herbal products, veterinary vaccines and additional antiretroviral drugs and formulations, inclusive of commonly used fixed- dose combinations. Standards for new drugs and drugs used under National Health Programmes are added and the drugs as well as their formulations not in use now a days are omitted from this edition. The number of monographs of Excipients, Anticancer drugs, Herbal products and Antiretroviral drugs have been increased in this edition. Monographs of Vaccines and Immunosera are also upgraded in view of development of latest technology in the field. A new chapter on Liposomal products and a monograph of Liposomal Amphotericin B injection is an added advantage in view of latest technology adopted for drug delivery. A chapter on NMR is incorporated in Appendices. The chapter on microbial contamination is also updated to a great extent to harmonise with prevailing international requirements. Format In an effort to make the pharmacopoeia more user-friendly, design of the texts of the monographs and of the test methods are kept same. Cross-referencing has been avoided to make each monograph complete in itself thus making it convenient to the analyst. Basis of Pharmacopoeial Requirements As in the past, this compendium provides a publicly available statement concerning the quality of a product that can be expected and demonstrated at any time throughout the accepted shelf-life of the article. The standards laid down represent the minimum with which the article must comply and it is inculcate on the manufacturer to ensure that the article is manufactured in accordance with the Good Manufacturing Practices (GMPs). It is essential that sufficiently stringent limits are applied at the time of release of a batch of a drug substance or drug product so that the pharmacopoeial standards are met until its expiry date when stored under the storage conditions specified. It must be noted that a valid interpretation of any requirement of the Pharmacopoeia should be done in the context of the monograph as a whole, the relevant general monograph, where appropriate, the specified tests and methods of analysis including any reference to the relevant General Notices. Familiarity with the General Notices will facilitate the correct application of the requirements. Changes Keeping in view the essential requirement under the Drugs and Cosmetics Act, 1940 and Rules thereunder in the information on category of a drug, dosage and usual available strengths of dosage forms has been re-kept in this edition. General chemical tests for identification of an article have been almost eliminated and the more specific infrared and ultraviolet spectrophotometric tests have been given emphasis. The concept of relying on published infrared spectra as a basis for identification has been continued. The use of chromatographic methods has been greatly extended to cope with the need for more specificity in assays and in particular, in assessing the nature and extent of impurities in drug substances and drug products. Most of the existing Assays and Related substances tests are upgraded by liquid chromatography method in view to have more specificity and to harmonise with other International Pharmacopoeias. The test for pyrogens involving the use of animals has been virtually eliminated. The test for bacterial endotoxins introduced in the previous edition is now applicable to more items. The test for abnormal toxicity is now confined to certain vaccines. General Chapters Volume I is devoted mainly to test methods that are applicable to all the articles of the pharmacopoeia and general information ii INTRODUCTION IP 2010 pertaining to the quality requirements of medicinal substances. It also includes reference data such as reference spectra, typical chromatograms etc. The test methods reflect the sophistication of analytical methodology and instrumentation. Analytical methods are, in general, in harmony with those adopted internationally for monitoring the quality of drugs. The steps taken for harmonization have been initiated by the need to cope with the increasing demand for drugs manufactured in the country to meet globally accepted standards. The trend towards controlling the microbial quality of all medicinal products has been recognized and the requirement regarding limits of bacterial contamination even of products for oral administration and topical application so that adequate controls are exercised by manufacturers by the adoption of GMPs has been continued. The chapter on Vaccines: General requirements has been updated. Minor corrections have been made in the appendices entitled Tests on Chicken flocks free from specified pathogens for the production and quality control of vaccines and General provisions: Avian viral vaccines- Tests for extraneous agents in seed lot. The peptide mapping test for Inactivated Hepatitis B Vaccine has been deleted. Wherever appropriate, other corrections have also been incorporated and overall presentation improved. In view of considering the microbiological quality, the whole microbiological general chapter comprising of effectiveness of antimicrobial preservatives, microbial contamination in nonsterile products and microbiological quality of raw material, dosage forms, herbs, processed herbs and herbal products have been extensively revised. For the first time in this chapter the analysis of strain Shigella boydii has been introduced which is possibly not available in other Pharmacopoeias. The addition of this strain Shigella boydii is essential as it is acute dysentry causing strain of tropical region of our country. The chapter on biotechnology derived therapeutic products has been fully revised. Special emphasis has been given on monoclonal antibodies Antisera. Monographs The General Monographs for dosage forms of active pharmaceutical ingredients (APIs) are grouped together at the beginning of Volume II. They are followed by the monographs for the APIs, pharmaceutical aids and individual dosage forms, all in alphabetical order. Monographs for other articles of a special nature such as vaccines and immunosera for human use, herbs and herbal products, blood and blood related products, biotechnology products and veterinary products are given in separate sections in Volume III. A list of 287 new monographs items not included in the 2007 edition of the Indian Pharmacopoeia and its addendum 2008 but added in this edition is given below: Admissions Monographs on drug substances, dosage forms and pharmaceutical aids Acepromazine Maleate Allantoin Aluminium Magnesium Silicate S-Amlodipine Besylate S-Amlodipine Tablets Liposomal Amphotericin B Injection Anastrozole Anastrozole Tablets Anhydrous Lactose Artesunate Atazanavir Sulphate Atazanavir Capsules Benzoic Acid Solution Betamethasone Dipropionate Betamethasone Cream Betamethasone Lotion Betamethasone Ointment Bifonazole Bifonazole Cream Bumetanide Bumetanide Injection Bumetanide Oral solution Bumetanide Tablets Butylparaben Calcium Chloride Injection Capecitabine Capecitabine Tablets Cefamandole Nafate Cefamandole Injection Cetrimide Cream Cetyl Palmitate Chlorothiazide Chlorothiazide Oral Suspension Chlorothiazide Tablets Chymotrypsin Cilastatin Sodium Clindamycin Hydrochloride Clindamycin Capsules iii IP 2010 INTRODUCTION Codeine Phosphate Tablets Cyproterone Acetate Cyproterone Tablets Daunorubicin Hydrochloride Daunorubicin Injection Dexchlorpheniramine Maleate Dexchlorpheniramine Oral Solution Dexchlorpheniramine Tablets Dextropropoxyphene Hydrochloride Dextropropoxyphene Capsules Dextropropoxyphene Napsilate Diacerein Diacerein Capsules Diazoxide Diazoxide Tablets Dicloxacillin Sodium Dicloxacillin Capsules Dicloxacillin Oral Suspension Diethanolamine Dihydroergocristine Mesylate Dihydroergotamine Mesylate Dimethicone Disopyramide Disopyramide Capsules Disopyramide Phosphate Capsules Disopyramide Phosphate Sustained- release Capsules Divalproex Sustained-release Tablets Docetaxel Trihydrate Docetaxel Injection Domperidone Doxofylline Doxofylline Tablets Enoxaparin Sodium Enoxaparin Injection Escitalopram Oxalate Escitalopram Tablets Estradiol and Norethisterone Tablets Etodolac Etodolac Capsules Etodolac Tablets Famotidine Famotidine Tablets Felodipine Felodipine Sustained-release Tablets Fenbendazole Fenofibrate Fentanyl Fentanyl Citrate Fentanyl Injection Finasteride Finasteride Tablets Fluconazole Fluconazole Capsules Fluconazole Tablets Flucytosine Flucytosine Capsules Flucytosine Oral Suspension Flucytosine Tablets Fluorescein Injection Flutamide Flutamide Capsules Fumaric Acid Gefitinib Gefitinib Tablets Gemifloxacin Mesylate Gemifloxacin Tablets Gliclazide Gliclazide Tablets Glimepiride Glimepiride Tablets Homatropine Methylbromide Homatropine Methylbromide Tablets Hyoscyamine Sulphate Hyoscyamine Injection Hyoscyamine Oral Solution Hyoscyamine Tablets Ibuprofen Cream Ibuprofen Gel Imatinib Mesylate Imatinib Capsules Indapamide Tablets Isobutane Isopropyl Myristate Lactulose Lamotrigine Sustained-release Tablets Lansoprazole Lansoprazole Sustained-release Capsules Lecithin Levosalbutamol Sulphate Linezolid Linezolid Tablets Losartan Potassium and Amlodipine Tablets Losartan Potassium and Hydrochlorothiazide Tablets Maleic Acid Malic Acid Maltitol Liquid Maltitol Maltodextrin Mefloquine Hydrochloride Meloxicam Oral Suspension Menthol and Benzoin Inhalation Metformin Hydrochloride Sustained- release Tablets Methadone Linctus Metronidazole Sterile Suspension Miconazole Microcrystalline Cellulose and Carboxymethylcellulose Sodium Misoprostol Mometasone Furoate Mometasone Aqueous Nasal Spray Mometasone Cream Mometasone Ointment Montelukast Sodium Montelukast Tablets Mycophenolate Mofetil Mycophenolate Mofetil Capsules Myristic Acid Naloxone Hydrochloride Naloxone Injection Naltrexone Hydrochloride Naltrexone Tablets Naproxen Naproxen Oral Suspension Naproxen Suppositories Naproxen Sustained-release Tablets Naproxen Tablets Neotame iv INTRODUCTION IP 2010 Ondansetron Orally Disintegrating Tablets Ondansetron Oral Solution Pantoprazole Sodium Pantoprazole Sustained-release Tablets Perphenazine Perphenazine Tablets Phenoxyethanol Phenylpropanolamine Hydrochloride Phenytoin Phenytoin Capsules Phenytoin Oral Suspension Pimozide Pimozide Tablets Piperacillin Piperacillin Intravenous Infusion Poloxamers Polyoxyl 35 Castor Oil Polyoxyl 40 Hydrogenated Castor Oil Potassium Sorbate Pravastatin Sodium Pravastatin Tablets Praziquantel Praziquantel Tablets Prednisolone Acetate Pregabalin Pregabalin Capsules Pregelatinised Starch Progesterone Injectable Suspension Promazine Tablets Propane Propionic Acid Propofol Propofol Injection Protriptyline Hydrochloride Protriptyline Tablets Pyrimethamine Tablets Quiniodochlor Cream Quiniodochlor Ointment Quiniodochlor and Hydrocortisone Cream Quiniodochlor and Hydrocortisone Ointment Ramipril and Hydrochlorothiazide Tablets Ribavirin Ribavirin Inhalation Solution Serratiopeptidase Serratiopeptidase Tablets Sildenafil Citrate Sildenafil Tablets Simvastatin Simvastatin Tablets Sorbitan Oleate Sucralose Sumatriptan Sumatriptan Injection Telmisartan Telmisartan Tablets Temozolomide Temozolomide Capsules Terazosin Hydrochloride Thiocolchicoside Thiocolchicoside Capsules Ticarcillin and Clavulanic Acid Injection Tolazamide Tolazamide Tablets Tolnaftate Tolnaftate Cream Tolnaftate Gel Tolnaftate Topical Powder Tolnaftate Topical Solution Tolterodine Tartrate Tramadol Hydrochloride Tramadol Capsules Trandolapril Trandolapril Tablets Travoprost Travoprost Eye drops Tributyl Citrate Trichloromonofluoromethane Triethyl Citrate Trimetazidine Hydrochloride Valproate Injection Valproic Acid Valproic Acid Capsules Valproic Acid Oral Solution Valsartan Valsartan Tablets Valsartan and Hydrochlorothiazide Tablets Vancomycin Hydrochloride Vancomycin Capsules Vancomycin Intravenous Infusion Vancomycin Oral Solution Xanthan Gum Zoledronic Acid Zoledronic Acid Injection Herbal Monographs Amla Juice Powder Arjuna Dry Extract Ashwagandha Dry Extract Belladonna Tincture Bhibhitaki Aqueous Extract Brahmi Extract Coconut Oil Coleus Dry Extract Coriander Oil Garcinia Aqueous Extract Haridra Dry Extract Haritaki Extract Haritaki Aqueous Extract Ipecac Tincture Lavang Methi Neem Sarpagandha Powder Sarpagandha Tablets Sunthi Extract Tulasi Dry Extract Vasaka Extract Veterinary Monographs Infectious Bursal Disease Vaccine , Live Infectious Chicken Aneamia Vaccine, Inactivated Infectious Chicken Aneamia Vaccine, Live Marek’s Disease Vaccine, Live Reo Virus Vaccine, Inactivated Reo Virus Vaccine, Live v IP 2010 INTRODUCTION Salmonella Vaccine, Inactivated Sterile Diluent for Live Vaccines Monographs upgraded Monographs on drug substances, dosage forms and pharmaceutical aids Acarbose Aciclovir Adrenaline Injection Alprazolam Alprazolam Tablets Aminophylline Aminophylline Injection Aminophylline Tablets Amitriptyline Hydrochloride Amodiaquine Tablets Arginine Arteether Artemether Artemesinin Atorvastatin Calcium Azithromycin Azithromycin Oral Suspension Azithromycin Tablets Bacitracin Bacitracin Zinc Benzyl alcohol Bromhexine Hydrochloride Bromhexine Tablets Bromocriptine Mesylate Bromocriptine Capsules Bromocriptine Tablets Bisacodyl Bisacodyl Tablets Buprenorphine Hydrochloride Benzhexol Hydrochloride Calcium Gluconate Tablets Calcium Levulinate Calcium Stearate Captopril Citric Acid Citric Acid Monohydrate Cellulose Acetate Phthalate Clofazimine Capsules Carbimazole Carvedilol Tablets Cefadroxil Crospovidone Cefuroxime Injection Cefaclor Oral suspension Cefadroxil Capsules Cefotaxime Sodium Cefazolin Sodium Cefixime Cinnarizine Cefaperazone Sodium Cefazolin Injection Cimetidine Tablets Cephalexin Cetostearyl Alcohol Cetyl Alcohol Carbimazole Tablets Cefadroxil Tablets Chlordiazepoxide Cisplatin Clopidogrel Bisulphate Clopidogrel Tablets Clotrimazole Cream Cresol with Soap Solution Cytarabine Danazol Danazol Capsules Desferrioxamine Mesylate Desferrioxamine Injection Dexamethasone Sodium phosphate Dextromethorphan Hydrobromide Dibutyl Phthalate Dicyclomine Injection Digoxin Disodium Edetate Diphenhydramine Hydrochloride Erythromycin Estolate Esomeprazole Magnesium Trihydrate Esomeprazole Tablets Ethambutol Hydrochloride Ferrous Gluconate Ferrous Sulphate Dried Ferrous Sulphate Fexofenadine Hydrochloride Fluocinolone Acetonide Fluorescein Injection Folic Acid Frusemide Frusemide Injection Frusemide Tablets Gallamine Triethiodide Gallamine Injection Gentamycin Sulphate Glibenclamide Glibenclamide Tablets Guaiphenesin Heparin Sodium Heparin Injection Ibuprofen Ibuprofen Tablets Imipenem Imipenem and Cilastatin Injection Isoxsuprine Hydrochloride Ketamine Hydrochloride Ketamine Injection Ketonazole Ketonazole Tablets Ketoprofen Ketoprofen Capsules Lactose Levamisole Tablets Levocitrizine Hydrochloride Levocetirizine Tablets Levofloxacin Tablets Magnesium Stearate Magnesium Trisilicate Mannitol Mannitol Injection Mebendazole Mebendazole Tablets Megestrol Acetate Mercaptopurine Methotrexate Injection Methylergometrine Tablets Metronidazole Metronidazole Tablets Metronidazole Injection Morphine Sulphate vi INTRODUCTION IP 2010 Mosapride Citrate Dihydrate Naphazoline Nitrate Nebivolol Hydrochloride Nebivolol Tablets Nefedipine Sustained- release Tablets Niclosamide Niclosamide Tablets Nitrazepam Nitrazepam Tablets Nitrofurazone Norethisterone Noscapine Nystatin Ofloxacin Olanzapine Omeprazole Ondansetron Tablets Oxytocin Oxytocin Injection Oxytocin Nasal Solution Phenobarbitone Phenobarbitone Sodium Paracetamol Paracetamol Tablets Diluted Pentaerythritol Tetranitrate Pentamidine Isethionate Pentamidine Injection Pethidine Hydrochloride Pethidine Injection Phenolphthalein Phenylbutazone Piracetam Piroxicam Polysorbate 20 Polysorbate 80 Potassium Iodide Povidone Prednisolone Propranolol Hydrochloride Propranolol Injection Propranolol Tablets Pseudoephedrine Hydrochloride Pyrantel Pamoate Quetiapine Fumarate Quinine Dihydrochloride Injection Rabeprazole Tablets Riboflavine Sodium Phosphate Ritonavir Tablets Salbutamol Salbutamol Sulphate Salbutamol Injection Salmeterol and Fluticasone Propionate Powder for Inhalation Secnidazole Sodium Alginate Sorbitol Soritol Solution (70 per cent) (Crystallizing) Soritol Solution (70 per cent) (Non- crystallizing) Spironolactone Spironolactone Tablets Sodium Fusidate Sodium Fusidate Capsules Sodium Propylparaben Sodium Methylparaben Methylparaben Propylparaben Stearyl Alcohol Sucrose Sulphacetamide Sodium Sulphacetamide Eye drops Talc Terbutaline Tablets Theophylline Theophylline Tablets Thiamine Hydrochloride Thiamine Nitrate Tenofovir and Emtricitabine Tablets Terbutaline Sulphate Thiotepa Topiramate Tablets Verapamil Hydrochloride Verapamil Tablets Vessopressin Injection Vincristine Sulphate Vincristine Injection Xylometazoline Hydrochloride Warfarin Sodium Warfarin Sodium Clatharate Zidovudine Tablets Monographs on Vaccines for Human Use Diphtheria and Tetanus Vaccine (Adsorbed) for Adults and Adolescents Diphtheria, Tetanus and Pertussis Vaccine (Adsorbed) Diphtheria, Tetanus, Pertussis (Whole Cell), Hepatitis B (rDNA) and Haemophilus Type b Conjugate Vaccine (Adsorbed) Hepatitis B Vaccine (rDNA) Measles, Mumps and Rubella Vaccine (Live) Tetanus Vaccine (Adsorbed) Monographs on Vaccines for Veterinary Use Avian Infectious Bronchitis Vaccine, Inactivated Avian Infectious Bronchitis Vaccine, Live Avian Spirochaetosis Vaccine Egg Drop Syndrome’76 (Adenovirus) Vaccine, Inactivated Foot-and-Mouth Disease Vaccine, Inactivated Fowl Cholera Vaccine, Inactivated Fowl Pox Vaccine, Live Inclusion Body Hepatitis (IBH) Vaccine, Inactivated Infectious Avian Encephalomyelitis Vaccine, Live Infectious Bursal Disease Vaccine, Inactivated Infectious Coryza Vaccine Peste Des Petits Ruminants Vaccine, Live Ranikhet Disease Vaccine, Inactivated Ranikhet Disease Vaccine, Live (Lentogenic Strain) Ranikhet Disease Vaccine, Live (Mesogenic Strain) Monographs on Veterinary Diagnostics Avian Mycoplasma Antigen Salmonella Pullorum Antigen vii IP 2010 INTRODUCTION Changed Titles of Monographs From ‘Leptospira Veterinary Vaccine, Inactivated’ to ‘ Canine Leptospirosis Vaccine, Inactivated’ From ‘Avian Pleuropneumonia Live Antigen’ to ‘ Avian Mycoplasma Antigen’ From ‘Salmonella Pullorum Coloured Antigen’ to ‘Salmonella Pullorum Antigen’ Omissions Adenine Aluminium Sulphate Analgin Analgin Tablets Butylated Hydroxyanisole Caramel Cyclopropane Deslanoside Deslanoside Injection Dibutyl Phthalate Emetine Hydrochloride Emetine Injection Ephedrine Erythromycin Estolate Erythromycin Estolate