THE UNANI PHARMACOPOEIA OF INDIA Ministry of AYUSH

The Unani Pharmacopoeia Of India Ministry Of Ayush-Free PDF

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THE, UNANI, PHARMACOPOEIA, OF, INDIA, PART II, VOLUME III. Formulations , First Edition, Government of India. Ministry of AYUSH, 2016, Published by, PHARMACOPOEIA COMMISSION FOR INDIAN MEDICINE HOMOEOPATHY. GHAZIABAD, i, PDH 73 Pt II Vol III, 2000 2015 DSK II . 2016 Pharmacopoeia Commission for Indian Medicine Homoeopathy. Ministry of AYUSH Government of India,On behalf of Government of India.
Ministry of AYUSH , AYUSH Bhawan B Block , GPO Complex INA New Delhi 110 023. Published by Pharmacopoeia Commission for Indian Medicine Homoeopathy. PLIM Campus Kamla Nehru Nagar , Ghaziabad 201002 U P India. ii, iv, vi, LEGAL NOTICES, In India there are laws dealing with drugs that are the subject of monographs which follow These. monographs should be read subject to the restrictions imposed by these laws wherever they are applicable . It is expedient that enquiry be made in each case in order to ensure that the provisions of the law. are being complied with , In general the Drugs Cosmetics Act 1940 subsequently amended in 1964 and 1982 the. Dangerous Drugs Act 1930 and the Poisons Act 1919 and the rules framed there under should be. consulted , Under the Drugs Cosmetics Act the Unani Pharmacopoeia of India UPI Part II Volumes are.
the books of standards for compound formulations included therein and the standards prescribed in the. Unani Pharmacopoeia of India Part II Vol III would be official If considered necessary these standards. can be amended and the Pharmacopoeia Commission for Indian Medicine Homoeopathy is authorized. to issue such amendments Whenever such amendments are issued the Unani Pharmacopoeia of India . Part II Vol III would be deemed to have been amended accordingly . vii, GENERAL NOTICES, Title The title of the book is Unani Pharmacopoeia of India Part II Volume III Wherever the. abbreviation UPI Pt II Vol III is used it may be presumed to stand for the same and the supplements. or amendments thereto , Name of the Formulation The name given on top of each monograph is in Arabic Persian or Urdu as. mentioned in the National Formulary of Unani Medicine NFUM and will be considered official These. names have been arranged in English alphabetical order under each category of dosage form . Ingredients and Processes Formulations are prepared from individual ingredients that comply with the. requirements for those individual ingredients for which monographs are provided in the volumes of. UPI Ayurvedic Pharmacopoeia of India API Part I Where water is used as an ingredient it should meet. the requirements for Purified Water covered by its monograph in the Indian Pharmacopoeia IP . Monograph for each formulation includes the full composition together with directions for its. preparation Such composition and directions are intended for preparation of small quantities for short . term supply and use When so prepared no deviation from the stated composition and directions is. permitted However if such a preparation is manufactured on a large scale with the intention of sale or. distribution deviations from the directions given are permitted but maintaining the same ratio as stated. in the monographs with the ingredients complying with the compendial requirements and also that the. final product meets the following criteria , a complies with all of the requirements stated in the monograph on compound formulations . b in the composition of certain formulations it has been allowed that a specified part of the plant may. be substituted by another part of the same plant In such cases the manufacturer should mention on. the label the actual part of the plant used in the formulation . c wherever a formulation composition specifies a drug that is banned from commerce this may be. omitted and the fact mentioned on the label , If a preparation is intended to be stored over a period of time deterioration due to microbial. contamination may be inhibited by the addition to the formula of a permitted preservative In such. circumstances the label should state the concentration of the preservative and the appropriate storage. conditions It is implied that such a preparation will be effectively preserved according to the appropriate. criteria applied , The direction that an ingredient in a formulation must be freshly prepared indicates that it must be.
prepared and used within 24 hours , Monograph Each monograph begins with a definition and introductory paragraph indicating the. formulation composition scientific names of the drugs used with their botanical parts along with a brief. account of the method of preparation , The requirements given in the monographs are not framed to provide against all impurities . contaminants or adulterants they provide appropriate limits only for possible impurities that may be. permitted to a certain extent Material found to contain an impurity contaminant or adulterant which is. not detectable by means of the prescribed tests are also to be considered as impurity should rational. consideration require its absence , Standards For statutory purposes the following shall be considered official standards Definition . Formulation composition Identification Physico chemical parameters Assay and other requirements . Added Substances A formulation contains no added substances except when specifically permitted in. the individual monograph Unless otherwise specified in the individual monograph or elsewhere in the. General Notices suitable substances may be added from the approved list of Drugs and Cosmetics Rules . under Rule 169 to a formulation to enhance its stability usefulness elegance or to facilitate its. preparation Such auxiliary substances shall be harmless in the amounts used shall not exceed the. viii, minimum quantity required to provide their intended effect shall not impair the therapeutic efficacy or. the bioavailability and safety of the preparation and shall not interfere with the tests and assays prescribed. for determining compliance with the official standards Particular care should be taken to ensure that such. substances are free from harmful organisms Though the manufacturer of a formulation is given the. freedom to use an added substance the manufacturer must guarantee the innocuousness of the added. substance The manufacturer shall also be responsible to explain to the appropriate authority if needed . regarding the purpose of the added substance s , Description Statement given under this title is not to be interpreted in a strict sense although they may.
help in the evaluation of an article However substantial departure from the requirement will not be. acceptable , Capital Letters in the Text The names of the Pharmacopoeial substances preparations and other. materials in the text are printed in capital initial letters and these infer that materials of Pharmacopoeial. quality have been used , Italics Italic types are used for Scientific names of the plant drugs and microorganisms and for some. sub headings and certain notations of the chemical names Italic types have also been used for words. which refer to solvent system in TLC procedure reagents and substances processes covered under. Appendices Chemicals and Reagents and Substances of Processes in Appendices have also been printed. in Italics , Odour and Taste Wherever a specific odour has been observed it has been mentioned as characteristic. for that formulation but the description as odourless or no odour has generally been avoided in the. Description where a substance has no odour Where a characteristic odour is said to be present it is. examined by smelling the drug directly after opening the container If such an odour is discernible the. contents are rapidly transferred to an open vessel and re examined after 15 minutes If odour persists to. be discernible the sample complies with the description for odour characteristic for that formulation . The taste of a drug is examined by taking a small quantity of drug by the tip of moist glass rod and. allowing it on tongue previously moistened with water This does not apply in the case of poisonous drugs . Powder fineness Wherever the powder of a drug is required it shall comply with the mesh number. indicated in the Monograph , Where particle size is prescribed in a Monographs the specified sieve number are used to fractionate a. weighed representative sample from the container each fraction weighed separately and expressed as a. percentage of the weight taken initially to obtain compliance with the monograph . Weights and Measures The metric system of weights and measures is employed Weights are given in. multiples or fractions of a gram g or of a milligram mg Fluid measures are given in multiples of. fraction of milliliter ml The amount stated is approximate but the quantity actually used must be. accurately weighed and must not deviate by more than 10 per cent from the one stated . When the term drop is used measurement is to be made by means of a tube which delivers 20. drops per gram of distilled water at 15 , Identity Purity and Strength Under the heading Identification tests are provided as an aid to.
identification and are described in the respective monographs Microscopical characters are prescribed for. the individual ingredients where these do not exceed ten in number added in situ Appendix 2 1 gives. detailed procedure , Vegetable drugs used in formulations should be duly identified and authenticated and be free from. insects pests fungi microorganisms pesticides and other animal matter including animal excreta be. within the permitted and specified limits for lead arsenic and heavy metals and show no abnormal odour . colour sliminess mould or any sign of deterioration . ix, The quantitative tests like total ash acid insoluble ash water soluble ash alcohol soluble. extractive water soluble extractive moisture content volatile oil content and assays are the parameters. upon which the standards of Pharmacopoeia depend Except for Assays which are covered under each. monograph the methods of determination for others are given in Appendices with a suitable reference to. the specific appendix , The analyst is not precluded from employing an alternate method in any instance if he is satisfied. that the method which he uses will give the same result as the Pharmacopoeial method described under. assay However in the event of doubt or dispute the methods of analysis of the Pharmacopoeia are alone. authoritative Unless otherwise prescribed the assays and tests are carried out at a temperature between. 20 and 30 , In the performance of assay or test procedures not less than the specified number of dosage units. should be taken for analysis Proportionately larger or smaller quantities than the specified weights and. volumes of assay or test substances and Reference Standards or Standard Preparations may be taken . provided the measurement is made with at least equivalent accuracy and provided that any subsequent. steps such as dilutions are adjusted accordingly to yield concentrations equivalent to those specified and. are made in such manner as to provide at least equivalent accuracy . Where it is directed in the assay for Tablet formulation to weigh and powder not less than a. given number usually 20 of the tablets it is intended that a counted number of tablets shall be weighed. and reduced to a fine powder Likewise where it is directed in the assay for Capsules to remove as. completely as possible the contents of not less than a given number usually 20 of the capsules it is. intended that a counted number of capsules should be carefully opened and the contents quantitatively. removed combined mixed and weighed accurately The portion of the powdered tablets or the mixed. contents of the capsules taken for assay is representative of the whole tablets or capsules respectively . and is in turn weighed accurately The result of the assay is then related to the amount of active. ingredients per tablet in the case of tablets and per capsule in the case of capsules from the weight of. contents of each tablet capsule , Limits for Heavy metals Microbial load Pesticide residues and Aflatoxin Formulations included in.
this volume are required to comply with the limits for heavy metals microbial load pesticide residues and. Aflatoxin prescribed in individual monographs and wherever limit is not given they must comply with the. limits given in Appendix The methods for determination of these parameters are given in Appendices . Thin Layer Chromatography TLC Under this title wherever given the Rf values given in the monographs. are not absolute but only indicative The analyst may use any other solvent system and detecting reagent to. establish the identity of any particular chemical constituent reported to be present in the formulation However. in case of dispute the pharmacopoeial method would prevail Unless specified in the individual monograph all. TLC have been carried out on pre coated Silica gel GF254 aluminium plates . Reference Standards Reference substance and standard preparation are authentic substances that have. been verified for their suitability for use as standards for comparison in some assays tests and TLC of the. UPI , Constant Weight The term constant weight when it refers to drying or ignition means that two. consecutive weighing do not differ by more than 1 0 mg per gram of the substance taken for the. Under the Drugs amp Cosmetics Act the Unani Pharmacopoeia of India UPI Part II Volumes are the books of standards for compound formulations included therein and the standards prescribed in the Unani Pharmacopoeia of India Part II Vol III would be official If considered necessary these standards

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