Indian Pharmacopoeia Volume 3 Pdf Free Download

TFP and CLR stock solutions (40 g/ml and 200 g/ml, respectively) were prepared by weighing accurately 2 mg TFP and 10 mg CLR powder into 2 separate 50 ml volumetric flasks; 25 ml methanol was added, shaken for a few minutes, and diluted to volume with methanol. From these solutions (2.5 ml) were transferred into 2 separate 10 ml volumetric flasks and diluted to the mark with methanol to give final concentrations of 10 and 50 g/ml, respectively. Accurate aliquots equivalent to 0.1-1 g TFP from its working solution (10 g/ml) and aliquots equivalent to 0.5-5 g CLR from its working solution (50 g/ml) were transferred into 2 separate sets of 5 ml volumetric flasks and diluted to volume with methanol. Powder from the mixed contents of 20 tablets, equivalent to 1 mg TFP and 10 mg CLR, was transferred accurately to a 50 ml volumetric flask and diluted to volume with methanol. The solution was diluted to the same concentrations of working standard solutions and treated according to the linearity for the RP-HPLC method. The separation was done on a C18 column using methanol:water (97:03, v/v) as the mobile phase. The chromatogram was recorded under the following instrumental parameters: 20 l injection volume, flow rate, 1.0 ml/min at 40 temperature and the eluent monitored at 262 nm. Calibration curves for both TFP and CLR were plotted, and the corresponding regression equations were calculated.

The nation is the largest provider of generic medicines globally, occupying a 20% share in global supply by volume, and is the leading vaccine manufacturer globally. India also has the highest number of US-FDA compliant Pharma plants outside of USA and is home to more than 3,000 pharma companies with a strong network of over 10,500 manufacturing facilities as well as a highly skilled resource pool.

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According to Mr. Bhagwant Khuba, Minister of State (MoS) for Chemicals and Fertilisers, India's pharmaceutical industry is the third largest by volume and the 13th largest by value in the world, generating more than 60,000 generic medications across 60 therapeutic categories.

Ethnopharmacological relevance: The Ayurvedic Pharmacopoeia of India (API) is a unique book of standards describing the quality, purity and strength of selected drugs that are manufactured, distributed, and sold by the licensed manufacturers in pan India. It is developed in two parts; the part one comprises of mono-monographs of medicinal substances of natural origin and part two includes selected compound formulations sourced from the schedule - I books under the Drugs and Cosmetics Act, 1940 comprising of popular Ayurvedic classics of different period of times. The first part of the Ayurvedic Formulary of India was published in 1978 and thereafter, the Ayurvedic Pharmacopoeia of India (mono-monograph) Part-I, Vol. I was published in the year 1989 and subsequently, the other volumes were published with their legalized status under Drugs and Cosmetics Act, 1940.

Aim of the study: The study was aimed to bring out the existing knowledge on the Ayurvedic pharmacopoeia with its chronological development reviewed from the ancient Vedic Compendia with its continuum in Ayurvedic classics of different period of time till recent past.

Conclusion: In India, the development of the Indian Pharmacopoeia started in 20th Century on the recommendation of the Col. R.N. Chopra Committee and in 1978 the first part of the Ayurvedic formulary of India was published. Subsequently, the amendment in the drugs and cosmetics Act 1940 was brought in 1964 for regulation of the drugs in Indian Systems of Medicine (Ayurveda, Unani and Siddha). Later on the Ayurvedic Pharmacopoeia of India (Mono-Monograph) Part-I, Volume I, was published in the year 1989 and the other volumes were published subsequently in different years.

The 6th edition of the 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. This edition would be effective from 1st September, 2010. 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.

Ketotifen fumarate, chemically known as 4-(1-methyl-4-piperidylidene)-4h-benzo [4, 5] cyclohepta [1, 2-b] thiophen-10(9h)-one hydrogen fumarate (Figure 2), is cycloheptathiophene blocker of histamine h-1 receptors used as an antiallergic and an antiasthmatic drug [9]. It is not official in Indian pharmacopoeia, British pharmacopoeia, United States pharmacopoeia, and European pharmacopoeia. The literature review reveals that HPLC [10, 11] and UV spectrophotometric methods [12, 13] have been reported for estimation of ketotifen fumarate in pharmaceutical dosage forms.

The salbutamol sulfate and ketotifen fumarate mixture is not yet official in any pharmacopoeia. As per literature, no analytical method could be traced for the analysis of salbutamol sulfate and ketotifen fumarate combination in pharmaceutical dosage forms. Therefore, simple, rapid, and reliable method for simultaneous estimation of these drugs in mixture seemed to be necessary.

Narcotine is the second most abundant alkaloid in opium[1] [2] [3] [4] . Opium from Madhya Pradesh, India, contains, on average, 7 per cent narcotine [5] . Narcotine is a non-narcotic and non-toxic alkaloid with no ill effects on blood pressure and respiration. It is used as an antitussive drug, particularly in wet cough, and is included in the British pharmacopoeia (BP), British Pharmaceutical Codex (B.P.C.) and Japanese Pharmacopoeia (J.P.) under the name of noscapine[6] [7] [8] [9] [10] [11] [12] . Cotarnine chloride B.P.C. 1934, State Pharmacopoeia of the Union of Soviet Socialist Republics (USSph), a styptic, and tritoqualine, an antihistamine, are synthetically prepared from narcotine[13] [14] [15] . Narcotine has no analgesic action and does not induce sleep or produce constipation. It is further used in the treatment of bronchial asthma and pulmonary emphysema. Noscapine B.P. and noscapine hydrochloride, United States National Formulary (U.S.N.F. XII) and J.P. are administered in the form of lozenges, linctus, syrup, tablets and resin-bound products.

Papaverine and papaverine hydrochloride and sulphate are described in the pharmacopoeiae of many countries. Papaverine occurs in opium collected in Madhya Pradesh, India [16] . Papaverine is a smooth-muscle relaxant. It is used as an antispasmodic in the treatment of intestinal, ureteric and biliary colic and of dysmenorrhoea. Being also a vasodilator, it is used to relieve pain in coronary and cerebral thrombosis; as a bronchodilator spray to relieve asthma and for the prevention of post-operative pulmonary collapse. Papaverine and narcotine hydrochloride are required in the production of Papaveretum B.P.C. [17] (pantopon and omnopon), which is used to relieve severe or prolonged labour pain. Papaverine from natural sources is supplemented by synthetic papaverine[18] [19] . India requires 1,350 kg per year of this alkaloid for medical purposes. The entire amount is presently imported.

In the Government Opium and Alkaloid Works, Neemuch, India, where opium collected from Madhya Pradesh (Malwa Opium) is used for the production of opium alkaloids, narcotine and papaverine are extracted as a crude mixture from the opium broth. No processes were available in the factory for the separation of narcotine and papaverine from this crude mixture or for their individual purification to meet pharmacopoeial specifications.

An amount of 200 g of the crude narcotine and papaverine mixture was dissolved in hot toluene, decolourized over activated carbon and filtered. The volume of the filtrate was reduced to one third by distillation and the alkaloids were allowed to crystallize. They were then filtered, washed with cold toluene and dried, yielding 170 g of an off-white crystalline product melting between 162 and 169C.

An amount of 40 kg of papaverine-free narcotine was dissolved in 200 l of hot toluene. This was gently agitated with 50 l of a 2% sodium hydroxide solution for 15 min, allowed to stand for 30 min, after which the aqueous layer was drawn out. The toluene fraction was then washed with l00 l of water to remove the adhering sodium hydroxide. This procedure helped to remove the phenolic alkaloids, resins and colouring matter present in the toluene solution. This solution was then heated in the presence of 500 g activated carbon and filtered. The filtrate was distilled to less than half the volume. The crystallized narcotine was centrifuged, using a terylene filter cloth in the basket. The material was then washed in the machine with 4l each of cold toluene and cold 95% alcohol. Narcotine thus obtained was a white crystalline powder which satisfied the specifications in the pharmacopoeia. Yield: 32.0 kg (first crop). 17dc91bb1f