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INDIAN PHARMACOPOEIA 2007 Volume 1 THE INDIAN PHARMACOPOEIA COMMISSION GHAZIABAD ISBN 81-903436-0-3 © 2007, Indian Pharmacopoeia Commission Application for reproduction should be made to the INDIAN PHARMACOPOEIA COMMISSION Sector-23, Raj Nagar, Ghaziabad-201 002 India Tale: (91-120) – 2783401 Fax: (91-120) – 2783311 Web-site: www.ipc.gov.in E.mail: [email protected] Effective from 31st March 2008 On behalf of : GOVERNMENT OF INDIA MINISTRY OF HEALTH & FAMILY WELFARE Designed, produced & published by : THE INDIAN PHARMACOPOEIA COMMISSION CENTRAL INDIAN PHARMACOPOEIA LABORATORY GOVT. OF INDIA, MINISTRY OF HEALTH & FAMILY WELFARE SECTOR-23, RAJ NAGAR, GHAZIABAD-201 002. Printed by : NATIONAL INSTITUTE OF SCIENCE COMMUNICATION AND INFORMATION RESOURCES (NISCAIR) COUNCIL OF SCIENTIFIC & INDUSTRIAL RESEARCH PUSA GATE, K. S. KRISHNAN MARG, NEW DELHI – 110012 Price: Inland Rs 25000.00 Foreign - $ 1000.00 £ 500.00 IP 2007 NOTICES Notices Legal Notices Scientific Director is authorised to issue such amendments. Whenever such amendments are issued, the Indian In India, under the Drugs and Cosmetics Act 1940, the current Pharmacopoeia would be deemed to have been amended edition of Indian Pharmacopoeia is a book of standards for accordingly. drugs included therein and the standards as included in the Indian Pharmacopoeia would be official. Also, in several other Patents And Trade Marks laws of India, the Indian Pharmacopoeia is recognised as the standard book. It is expedient that enquiry be made in each In the Indian Pharmacopoeia, certain drugs and preparations case in order to ensure that the provisions of any such law are have been included notwithstanding the existence of actual being complied with. In general, the Drugs and Cosmetics or potential rights in any part of the world. In so far as such Act, 1940, the Narcotic Drugs and Psychotropic Substances substances are protected by Letters Patent their inclusion in Act, 1985, the Poisons Act, 1919 and the rules framed the Indian Pharmacopoeia neither conveys, nor implies, licence thereunder should be consulted. These statutes empower the to manufacture without due permission, authority, or licence Government agencies to enforce the law using this from the person or persons in whom such rights exist. compendium. The monographs of the Indian Pharmacopoeia The titles given under the individual monographs are public should be read subject to the restriction imposed by those property. These titles cannot be patented as trade marks and laws which are applicable. no person is permitted to patent any trade mark devising the If considered necessary, the standards included in Indian root of these titles. Pharmacopoeia can be amended and the Secretary-cum- v IP 2007 PREFACE Preface The Indian Pharmacopoeia 2007 is published by the Indian technology and experimental methods widely adopted in India Pharmacopoeia Commission (IPC) on behalf of the Government and abroad are being added and updated. The contents of of India, Ministry of Health & Family Welfare. The Government Appendices are revised by and large in consonance with those of India constituted the IPC vide their Order No. Z-14012/IPC/ nowadays adopted internationally for monitoring the quality CBP/ 2003 dated 22nd March 2005. The IPC is a Society under of the drugs. The monographs of special relevance to the the provisions of the Societies Registration Act, 1860 (Act common disease pattern of this region have been given special No. 21 of 1860) for the registration of Literary, Scientific and emphasis by incorporating such medicines. Charitable Societies. The functioning of the Commission is In addition, emphasis has been put to bring out harmonisation governed by the provisions of the approved Memorandum of in Appendices to a sound connection between individual Association, Rules and Regulations of the IPC. monographs and the relevant appendices, and to the The Commission has set up its headquarters in the campus of standardization of text wording so as to make this edition the Central Indian Pharmacopoeia Laboratory (CIPL), Sector- precise and well structured. The number of monographs in 23, Raj Nagar, Ghaziabad, UP. The Director CIPL, also Appendices are expanded further to incorporate the latest functions as the Secretary-cum-Scientific Director of the IPC. technological advances and complies with regulatory The CIPL is the support structure of the Commission. requirements. Great efforts have been made to unify the National Drug Standards and to bring them in line with the The Indian Pharmacopoeia is being produced in fulfillment of International Standards progressively by addition of the requirement in the Drugs and Cosmetics Rules, 1945 of monographs of new drugs and current methodology adopted. standards of drugs produced in India and in the belief that it contributes significantly in the control of the quality of Public Review and Comment Process for Standards Develop- medicinal products. The standards of this pharmacopoeia are ment Related to this edition of the Indian Pharmacopoeia have legally enforceable and are intended to help in the licensing been given special attention to incorporate comments from and inspection processes. stakeholders as shown below: After independence an Indian Pharmacopoeia Committee was constituted in 1948, which prepared the Pharmacopoeia of India (The Indian Pharmacopoeia) 1955. A Supplement to it was published in 1960. This pharmacopoeia contained western and also traditional drugs, and the same policy continued while preparing the Pharmacopoeia of India 1966 and its 1975 Supplement. In the Pharmacopoeia of India 1985 and its Addenda 1989 and 1991, traditional drugs were not included as publication of a pharmacopoeia of traditional system drugs was taken up separately and only those herbal drugs were included which had supporting definitive quality control standards. In the period since the publication of the 1985 Edition there has been a significant increase in the range of drugs produced in India. Keeping this in mind the Committee has deleted or added monographs on a system of priorities based on the medical merit and the extent of use of any given article in the country in its following 1996 Edition and its addenda in 2000, 2002, 2005 and one supplement for Veterninary Products in 2002. The Indian Pharmacopoeia 2007 has been prepared in accordance with the principles and designed plan decided by the Scientific Body of the Indian Pharmacopoeia Commission and completed with untiring efforts made by Commission members and its Secretariat over almost two years. The Indian Pharmacopoeia 2007 is presented on the user friendly format. The General Notices, Monographs and new testing methods, etc. based on the introduction of advanced vii PREFACE IP 2007 In addition to the traditional way of requesting for comments, adopts new style of formatting. The improvement of quality in the contents of revised appendices and monographs have printing and binding makes this edition look more elegant. been publicized on the website of the Indian Pharmacopoeia The Indian Pharmacopoeia 2007 is published in three volumes. Commission, aiming at collecting comments widely from It is presumed that the Pharmacopoeia would play a vital role various institutions and organizations. All the feedbacks and in initiating new prospect for improving the quality of medicines inputs have been reviewed by the relevant Expert Committee and would also help to accelerate development of Pharma to ensure the feasibility and practicability of the standards Sector. and methods revised in this edition of Pharmacopoeia, and The Commission places on record its appreciation of the ensure that the principle of “openness, justice and fairness” services of all the persons who have contributed to the is kept in the process of compiling and editing. production of this compendium. In order to make it easy for reading, understanding and interpreting the content of the Indian Pharmacopoeia 2007 viii IP 2007 INDIAN PHARMACOPOEIA COMMISSION Indian Pharmacopoeia Commission The Indian Pharmacopoeia Commission (IPC) has a three-tier • To accelerate the process of preparation, certification and structure comprising of the General Body of 19 members, distribution of IP Reference Substances, including the Governing Body of 8-10 members and Scientific Body of 15-23 related substances, impurities and degradation products. members from different related scientific fields; the number of • To collaborate with pharmacopoeias like the Ph Eur, BP, members of the Scientific Body may vary from time to time. USP, JP, ChP and International Pharmacopoeia with a view The Secretary, Ministry of Health and Family Welfare, is the to harmonizing with global standards Chairman and the the Chairman-Scientific Body is the Co- • To review existing monographs periodically with a view Chairman of the Commission. to deleting obsolete ones and amending those requiring upgradation / revision. • To organize educational programs and research activities for spreading and establishing awareness on the need and scope of quality standards for drugs and related articles / materials. The Governing Body IPC-Structure The composition of the Governing Body is given below: The primary responsibility of the Scientific Body is to provide Chairman The Secretary (Health & Family Welfare) guidlines for Standards development related to the Indian Government of India Pharmacopoeia with assistance of its Expert Committees. Ministry of Health & Family Welfare Nirman Bhawan The Indian Pharmacopoeia is published in continuing pursuit New Delhi-110 011. of the Mission, Vision and Objectives of the IPC. (Mr. Prasanna Hota until 30 October 2006 Mission Mr. Naresh Dayal from 31 October 2007 ) To promote public health in India by bringing out authoritative Co-Chairman Dr. Nitya Anand and officially accepted standard for quality of drugs including Ex-Director active pharmaceutical ingredients, excipients and dosage Central Drug Research Institute forms, used by health professionals, patients and consumers. B-62, Nirala Nagar Lucknow-226 020. Vision Member The Additional Secretary & Finance Advisor To promote the highest standards of drugs for use in humans Ministry of Health & Family Welfare and animals within practical limits of the technologies available Nirman Bhawan for manufacture and analysis. New Delhi -110 011. Objectives (Dr. Sanjiv Misra until 30 April 2006 Mr. Raghubir Singh from 30 May 2006) • To develop comprehensive monographs for drugs to be included in the Indian Pharmacopoeia, including active Invitee The Additional Secretary pharmaceutical ingredients, pharmaceutical aids and Ministry of Health & Family Welfare dosage forms as well as medical devices, and to keep Nirman Bhawan them updated by revision on a regular basis. New Delhi-110 011. • To develop monographs for herbal drugs, both raw drugs (Mr. Deepak Gupta) and extracts/formulations therefrom. Member The Joint Secretary (Drugs) • To accord priority to monographs of drugs included in Ministry of Health & Family Welfare, the National Essential Drugs List and their dosage forms. Nirman Bhawan • To take note of the different levels of sophistication in New Delhi-110 011. analytical testing/ instrumentation available while framing (Ms. Rita Teaotia until February 2007 the monographs. Mr. Debasish Panda from 2 April 2007 ) ix INDIAN PHARMACOPOEIA COMMISSION IP 2007 Member The Drugs Controller General (I), Member The Joint Secretary (Drugs) Directorate General of Health Services Ministry of Health & Family Welfare Ministry of Health & Family Welfare Nirman Bhawan, New Delhi. Nirman Bhawan (Ms. Rita Teaotia until February 2007 New Delhi-110 011. Mr. Debasish Panda from 2 April 2007 ) (Mr. Ashwini Kumar until 31 August 2006 Member The Drugs Controller General (I) Dr M. Venkateswarlu from 1 September 2006) Directorate General of Health Services Member The Director (Drugs) Nirman Bhawan, New Delhi. Ministry of Health & Family Welfare (Mr. Ashwini Kumar until 31 August 2006 Nirman Bhawan Dr. M. Venkateswarlu from 1 September2006) New Delhi-110 011. Member The Director (Mr. Rajesh Bhushan until 12 December 2006 National Institute of Biologicals Dr. Asha Thomas from January 2007) B-62, Institutional Area Member The Director Noida-201 307 National Institute of Biologicals (Dr. V. K. Kashyap) B-62, Institutional Area Noida-201 307 Member The Director (Dr. V. K. Kashyap) Central Drugs Laboratory 3, Kyd Street Invitee Dr. P. R. Pabrai Kolkata Ex-Director, Central Indian Pharmacopoeia (Dr. P. K. Chatterjee until December 2005) Laboratory, C-568, Sarita Vihar Member The Joint Drugs Controller New Delhi-110 076 North Zone Ghaziabad (U.P.) Member The Director (Dr. S. R. Gupta until 30 September 2005 Secretary Central Indian Pharmacopoeia Laboratory (Mr. N.C. Dhawan from 12 July 2007) Sector-23, Rajnagar Ghaziabad-201 002 Member The Director-Professor (Dr. G. N. Singh) Department of Pharmacology Jawaharlal Institute of Post graduate Medical The General Body Education and Research Pondicherry-605 006. The composition of the General Body is as follows: (Dr. C. Adithan) Chairman The Secretary (Health & Family Welfare) Member Commissioners in charge of Drug Control Government of India Administration, Andhra Pradesh Ministry of Health & Family Welfare Nirman Bhawan (Mr. Ranga Rao) New Delhi-110 011. Member Commissioners in charge of Drug Control (Mr. Prasanna Hota until 30 October 2006 Administration, Maharashtra Mr. Naresh Dayal from 31 October 2007 ) (Mr. A. Ram Krishnan) Member Dr. Nitya Anand Member Commissioners in charge of Drug Control Ex-Director, Central Drug Research Institute Administration, Gujarat B-62, Nirala Nagar (Dr S.P. Adeshara) Lucknow-226 020. Member Commissioners in charge of Drug Control Member The Additional Secretary & Finance Advisor, Administration, Uttar Pradesh Ministry of Health & Family Welfare (Mr. Satguru Prasad) Nirman Bhawan New Delhi 110 011. Member Commissioners in charge of Drug Control (Dr. Sanjiv Misra until 30 April 2006 Administration, Orissa Mr. Raghubir Singh from 30 May 2006) (Mr. B. C. Panda) x IP 2007 INDIAN PHARMACOPOEIA COMMISSION Member The Director Member Professor V. K. Kapoor National Institute of Pharmaceutical Education Ex-Dean and Chairman, Pharmaceutical and Research (NIPER) Sciences, Punjab University Sector 67, SAS Nagar 1743, Pushpae Complex Mohali-160 062. Sector 49 B (Professor P. Rama Rao) Chandigarh-160 047 Member The President Member Professor P. Rama Rao Indian Drug Manufacturer Association Director (IDMA) National Institute of Pharmaceutical Education 102-B, Poonam Chambers, ‘A’ Wing’ and Research (NIPER) Dr. Annie Besant Road, Worli Sector 67, SAS Nagar Mumbai – 400018 Mohali-160 062. (Mr. Suresh G. Kare) Member Mr. Parthajyoti Gogoi Director-in-Charge Member The President Regional Drugs Testing Laboratory (RDTL) Organizational of Pharmaceutical Producer of Khana Para, Panjabari, Six mile India (OPPI) Guwahati-781 037. (Shri Ranjit Sahani) Member Professor Saranjit Singh Member The President Professor and Head Association of Manufacturers of Ayurvedic Department of Pharmaceutical Analysis Medicines National Institute of Pharmaceutical Education (Mr. P. M. Shroff) and Research (NIPER) Member The Director Sector 67, SAS Nagar Secretary Central Indian Pharmacopoeia Laboratory Mohali-160 002. Sector-23, Rajnagar Member Dr. V. A. Srinivasan Ghaziabad-201 002 Research Director (Dr. G. N. Singh) Indian Immunologicals Ltd. Gachibowli Post Hyderabad-500 032. The Scientific Body Member Dr. Prem K. Gupta The list below includes those members who served during the Ex-Drugs Controller (I) period ouse No. 95 DDA Flats Chairman Dr. Nitya Anand Pocket ‘B’, Sukhdev Vihar Ex-Director New Delhi -110 025. Central Drug Research Institute B-62, Nirala Nagar Member Dr. S. N. Pal Lucknow-226 020 Executive Director HSCC Vice-Chairman Dr. P. R. Pabrai E-6(A), Sector-1, Ex-Director, Central Indian Pharmacopoeia Noida -201 301 Laboratory, C-568, Sarita Vihar Member Dr. D. B. Anantha Narayana New Delhi-110 076 Head, Herbal Research Hindustan Lever Research Centre Member Mr. R. S. Iyer Unilever Research India M.S.H. Layout, II Stage 64, Main Road, Whitefiled Anand Nagar Bangalore- 560 066. Bangalore-560 024. Member Mr. J. L. Sipahimalani Member Mr. Prafull D. Sheth 10-C, Ananta, R. Patel Lane E-256, Greater Kailash-I Mumbai-400 026 New Delhi-110 048. xi INDIAN PHARMACOPOEIA COMMISSION IP 2007 Member Dr. V. K. Lal Member Professor Y. K. Gupta College of Pharmacy, Head, Department of Pharmacology, Institute of Foreign Trade and Management All India Institute of Medical Sciences Lodhipur-Rajput Ansari Nagar Delhi-Moradabad Raod New Delhi. Moradabad. U.P. Invitee Mr.Gidy Asrani Member Dr. Anil Paul Kariath President, Pharmacon, President – Consulting & Training 3, Salmona Ville, North Avenue, Bangalore Biotech Labs. Pvt. Ltd. Santa Cruze, #49/2, Gubbi Cross, Off Hennur Cross Mumbai-400 054. Bangalore-560 077. Invitee Dr. Manish Gangrade Member Dr. P. G. Shrotriya Head - Analytical Development Lab. Chief Executive, Elite Pharma Consultants CIPLA Limited 11/302 Sea Woods, NRI Complex, Nerul Mumbai Navi Mumbai-400 706. Member Dr. G. N. Singh Member Dr. Vinay G. Nayak Secretary Director President, Tech. Operations Central Indian Pharmacopoeia Laboratory Watson Pharma Pvt. Ltd. Sector-23, Rajnagar Mumbai. Ghaziabad-201 002 Member Mr. Vinod Arora Vice-President (Pharma Research) Ranbaxy Research Laboratories Executive Committee Plot No. 20, Sector 18, Udyog Vihar Dr Nitya Anand, Dr. M Venkateswarlu*, Mr. P. D. Sheth, Mr. R. Industrial Area, S. Iyer and Dr. G. N. Singh. Gurgaon-122 001. *(Mr. Ashwini Kumar until 31 August 2006 Member Dr. T. G. Chandrashekhar Dr M. Venkateswarlu from 1 September 2006) Vice-President, Global Quality & Analytical Research, Ranbaxy Research Laboratories, Expert Committees Plot No. 20, Sector 18, Udyog Vihar Expert Committee on Anti-Retroviral Drugs Industrial Area Gurgaon-122 001 Dr. T. G. Chandrashekhar (Chair), Dr. K. M. Thomas, Mr. Antony Raj Gomes, Dr. S. Raghuveer, Dr. Pramod Dalvi, Dr. Member Dr. K. M. Thomas Manish Gangrade. T C/ 10 /1013 CO-OP-Housing Gardens, Expert Committee on Anti-Tuberculosis/Anti Asthma Drugs Mannamoola, Peroorkada P O Dr. Vinay G Nayak (Chair), Professor Saranjit Singh, Dr. Amarjit Thiruvananthapuram Singh, Mr. Satyawan Hatte. Kerala-695005. Expert Committee on Bioassay, Biostatistics and Toxicology Member Dr. Hemnalini Kumar Professor P. Rama Rao (Chair), Dr. Prakash V. Diwan, Dr. K. M. Director, Bio-Products Chacko. Salesworth India Ltd. 713 Syndicate Bank Road Expert Committee on Biotechnological and Recombinant Indira Nagar I Stage DNA Technology Products Bangalore-560 038 Dr. Anil Paul Kariath (Chair), Mr. Ganesh Kumaraj, Mr. S. V. Member Dr. Anoop Misra Kotbagi, Dr. Rustom Mody, Dr. Venkata Ramana. Former Professor Expert Committee on Blood and Blood Products All India Institute of Medical Sciences Ansari Nagar Dr. Prem K. Gupta (Chair), Mr. R. Narayana Swamy, Dr. Zareen New Delhi. Bharucha, Dr. Kabita Chatterjee, Mr. Atul Kr. Nasa. xii IP 2007 INDIAN PHARMACOPOEIA COMMISSION Expert Committee on Clinical Medicine and Pharmacology Professor Roop K. Khar, Dr. Praful R. Naik. Professor Y. K. Gupta (Chair), Dr. Anoop Misra, Professor P. Expert Committee on Publication and Information Technology Rama Rao, Dr. Rama Mukherjee, Dr. R. R. Kasliwal Dr. Hemnalini Kumar (Chair), Mr. Parthajyoti Gogoi, Dr. D. B. Expert Committee on Compounding Pharmacy and Website Anantha Narayana, Mr. Daara B. Patel, Dr. Sanjay Singh. Mr. Parthajyoti Gogoi (Chair), Professor Y. Madhusudan Rao, Expert Committee on Vaccines and Other Biological Products Dr. Prakash V. Diwan, Dr. A. Ramkishan, Dr. R. Sweety Prem Dr. V. A. Srinivasan (Chair), Dr. A. K. Tahlan, Dr. Surinder Kumar. Singh, Dr. Rishendra Verma, Dr. S. S. Jadhav. Expert Committee on Devices and Diagnostics Dr. S. N. Pal (Chair), Professor Alok Ray, Dr. G. S. IPC Secretariat Bhuvaneshwar, Sh. M. Mitra. An active and effective support to the Expert Committees is Expert Committee on Drug Nomenclature provided by the following staff members from CIPL. Professor V. K. Kapoor (Chair), Dr. (Mrs.) Dr Hardeep Wadhwa, Director CIPL Professor Yatendra Kumar. Dr. G. N. Singh Secretary-cum-Scientific Director Expert Committee on General Analytical Methods Research & Development Division Dr. T. G. Chandrashekhar (Chair), Professor Saranjit Singh, The major activities related to formatting, reviewing and Professor Y. K. Agrawal, Dr. K. M. Thomas, Dr. Milind Joshi. liasons for Standard Development is performed by following: Expert Committee on General Policies and Planning Dr. Raman Mohan Singh (Head), Dr. S. C. Mathur, Mr. Dinesh Kr. Sharma, Mr. Pawan Kr. Saini, Mr. Munendra Kr. Poonia and Mr. Prafull D. Sheth (Chair), Mr. B. N. Thakore, Dr. Shailesh Km. Anu Somvanshi. Nagarsenker, Professor Y. Madhusudan Rao, Mr. B. K. Sharma. Pharmacology & Microbiology Division Expert Committee on General Chapters and General Format The matters related to biologicals is taken care of by following: Mr. R. S. Iyer (Chair) . Dr. Jai Prakash (Head), Mr. Surendra Kr. Talwar, Mr. Charan Expert Committee on Herbal Products and Crude Drugs Singh Nivoria, Mr. Alok Sharma, Mr. Manoj Kr. Pandey and Dr. D. B. Anantha Narayana (Chair), Dr. S. S. Handa, Dr. G. S. Mr. Satyapal Singh. Lavekar, Dr. V. K. Lal, Dr. C. K. Katiyar, Dr. Amit Agarwal Publication Division Expert Committee on IP Reference Substances The issues related to publication, sales and marketing is Dr. M Venkateswarlu (Chair), Dr. P. R. Pabrai, Professor Saranjit looked after by following: Singh. Mr. K. K. Singh (Head), Mr. Udai Pal and Mr. Sudhakar Singh. Expert Committee on Medicinal Chemicals I Scientific, Administrative and Miscellaneous Support Dr. P. R. Pabrai (Chair), Dr. R. A. Singh, Dr. N. Murugesan, Dr. Support provided in Scientific and Administrative matters by K. K. Chakraborti, Dr. Ashok Panwar. following is appreciable: Expert Committee on Medicinal Chemicals II Mrs. Savita Shukala, Ms. Sangeeta Bhatnagar and Professor V. K. Kapoor (Chair), Professor Meenakshi Bajpai. Mr. Satyaprakash Tyagi Expert Committee on Medicinal Chemicals III Mr. R. C. Saxena, Mr. Tribhuvan Nautiyal, Mr. I. J. S. Oberoi and Mr. H. S. Rana. Mr. J. L. Sipahimalani (Chair), Ms Rashida Najmi, Dr. Prashant Dikshit, Ms V. R. Menon. Other Participants Expert Committee on Parenteral Products Participants other than those mentioned above who assisted Dr. P. G. Shrotriya (Chair), Mr. Sanjit Singh Lamba, in the work relating to preparation of this Pharmacopoeia are Dr. Sumant Baukhandi, Mr. G. S. Bedi, Mr. Satish. R. Kulkarni. given below: Expert Committee on Pharmaceutical Dosage Forms Dr. Abraham Patani, Dr. A. K. Singh, Mr. Arvind Kukrety, Dr. Mr. Vinod Arora (Chair), Professor Arvind K Bansal, A. Ram Krishan, Mrs. Annie Pillai, Mr. Arun Mendiratta, Mr. Dr Kona Subrahmanya Srinivas, Dr. Kisan B. Chaudhari, Arun Khosla, Mr. Atul Kumar Sharma, Ms. Ayesha Patial, Dr. xiii

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Mar 22, 2005 The titles given under the individual monographs are public property. These titles . USP, JP, ChP and International Pharmacopoeia with a view to harmonizing with Tenofovir Disoproxil Fumarate Tablets. Tenofovir and
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Most books are stored in the elastic cloud where traffic is expensive. For this reason, we have a limit on daily download.