the ayurvedic pharmacopoeia of india - ccras ( pdfdrive ), страница 2

In such circumstances the label should state the concentration of thepreservative and the appropriate storage conditions. It is implied that such a preparationwill be effectively preserved according to the appropriate criteria applied.The direction that an ingredient in a formulation must be freshly preparedindicates that it must be prepared and used within 24 hours.Monograph: Each monograph begins with a definition and introductory paragraphindicating the formulation composition, scientific names of the drugs used with theirbotanical parts along with a brief account of the method of preparation.The requirements given in the monographs are not framed to provide against allimpurities, contaminants or adulterants; they provide appropriate limits only for possibleimpurities that may be permitted to a certain extent.

Material found to contain animpurity, contaminant or adulterant which is not detectable by means of the prescribedtests are also to be considered as impurity should rational consideration require itsabsence.Standards: For statutory purposes, the following shall be considered official standards:Definition, Formulation composition, Identification, Physico-chemical parameters, Assayand Other requirements.Added Substances: A formulation contains no added substances except whenspecifically permitted in the individual monograph.

Unless otherwise specified in theindividual monograph, or elsewhere in the General Notices, suitable substances may beadded from the approved list of Drugs and Cosmetics Rules, under Rule 169 to aformulation to enhance its stability, usefulness, elegance, or to facilitate its preparation.Such auxiliary substances shall be harmless in the amounts used, shall not exceed theminimum quantity required to provide their intended effect, shall not impair thetherapeutic efficacy or the bioavailability and safety of the preparation and shall notinterfere with the tests and assays prescribed for determining compliance with the officialstandards.

Particular care should be taken to ensure that such substances are free fromharmful organisms. Though the manufacturer of a formulation is given the freedom to usean added substance, the manufacturer must guarantee the innocuousness of the addedsubstance. The manufacturer shall also be responsible to explain to the appropriateauthority, if needed, regarding the purpose of the added substance(s).Description: Statement given under this title is not to be interpreted in a strict sensealthough they may help in the evaluation of an article. However substantial departureform the requirement will not be acceptable.Capital Letters in the Text: The names of the Pharmacopoeial substances, preparationsand other materials in the text are printed in capital initial letters, and these infer thatmaterials 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 havealso been used for words which refer to solvent system in TLC procedure, reagents andsubstances, processes covered under Appendices. Chemicals and Reagents andSubstances of Processes in Appendices have also been printed in Italics.Odour and Taste: Wherever a specific odour has been observed it has been mentionedas characteristic for that formulation, but the description as ‘odourless’ or ‘no odour’ hasgenerally been avoided in the Description where a substance has no odour. Where acharacteristic odour is said to be present it is examined by smelling the drug directly afteropening the container. If such an odour is discernible, the contents are rapidly transferredto 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 ofmoist glass rod and allowing it on tongue previously moistened with water. This does notapply in the case of poisonous drugs.Powder fineness: Wherever the powder of a drug is required, it shall comply with themesh number indicated in the Monograph.Where particle size is prescribed in a Monographs, the specified sieve number are used tofractionate a weighed representative sample from the container, each fraction weighedseparately, and expressed as a percentage of the weight taken initially, to obtaincompliance 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).

Fluidmeasures are given in multiples of fraction of milliliter (ml). The amount stated isapproximate but the quantity actually used must be accurately weighed and must notdeviate 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 tubewhich delivers 20 drops per gram of distilled water at 150.Identity, Purity and Strength: Under the heading “Identification”, tests are provided asan aid to identification and are described in the respective monographs. Microscopicalcharacters are prescribed for the individual ingredients where these do not exceed ten innumber, added ‘in situ’.

Appendix 2.1 gives detailed procedureVegetable drugs used in formulations, should be duly identified and authenticatedand be free from insects, pests, fungi, micro organisms, pesticides, and other animalmatter 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 anysign of deterioration.The quantitative tests like total ash, acid-insoluble ash, water-soluble ash,alcohol-soluble extractive, water-soluble extractive, moisture content, volatile oil contentand assays are the parameters upon which the standards of Pharmacopoeia depend.Except for Assays, which are covered under each monograph, the methods ofdetermination for others are given in Appendices, with a suitable reference to the specificappendix.The analyst is not precluded from employing an alternate method in any instanceif he is satisfied that the method, which he uses will give the same result as thePharmacopoeial method described under assay.

However, in the event of doubt or disputethe methods of analysis of the Pharmacopoeia are alone authoritative. Unless otherwiseprescribed, the assays and tests are carried out at a temperature between 200 and 300.In the performance of assay or test procedures, not less than the specified numberof dosage units should be taken for analysis. Proportionately larger or smaller quantitiesthan the specified weights and volumes of assay or test substances and ReferenceStandards or Standard Preparations may be taken, provided the measurement is madewith at least equivalent accuracy and provided that any subsequent steps, such asdilutions, are adjusted accordingly to yield concentrations equivalent to those specifiedand 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 notless than” a given number, usually 20, of the tablets, it is intended that a counted numberof tablets shall be weighed and reduced to a fine powder.

Likewise, where it is directedin the assay for Capsules to remove, as completely as possible, the contents of not lessthan a given number, usually 20, of the capsules, it is intended that a counted number ofcapsules should be carefully opened and the contents quantitatively removed, combined,mixed, and weighed accurately. The portion of the powdered tablets or the mixedcontents 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 tothe amount of active ingredients per tablet in the case of tablets and per capsule in thecase of capsules from the weight of contents of each tablet/capsule.Limits for Heavy metals, Microbial load, Pesticide residues and Aflatoxins :Formulations included in this volume are required to comply with the limits for heavymetals, microbial load, pesticide residues and aflatoxins prescribed in individualmonographs and wherever limit is not given they must comply with the limits given inAppendix.

The methods for determination of these parameters are given in Appendices.Thin Layer Chromatography (TLC): Under this title, wherever given, the Rf valuesgiven in the monographs are not absolute but only indicative. The analyst may use anyother solvent system and detecting reagent to establish the identity of any particularchemical constituent reported to be present in the formulation.

However in case of disputethe pharmacopoeial method would prevail. Unless specified in the individual monographall TLC have been carried out on pre-coated Silica gelG F254 aluminium plates.Reference Standards: Reference substance and standard preparation are authenticsubstances that have been verified for there suitability for use as standards for comparisonin some assays, tests and TLC of the API.Constant Weight: The term “constant weight” when it refers to drying or ignition meansthat two consecutive weighing do not differ by more than 1.0 mg per gram of thesubstance taken for the determination, the second weighing following an additional hourof drying or further ignition.Percentage of Solutions – In defining standards, the expression per cent (%), is used,according to circumstances, with one of the four meanings given below.Per cent w/w (percentage weight in weight) expresses the number of grams of activesubstance in 100 grams of product.Per cent w/v (percentage weight in volume) expresses the number of grams of activesubstance in 100 milliliters of product.Per cent v/v (percentage volume in volume) expresses the number of milliliters of activesubstance in 100 milliliters of product.Per cent v/w (percentage volume in weight) expresses the number of milliliters of activesubstance in 100 grams of product.Percentage of Alcohol: All statements of percentage of alcohol (C2H5OH) refer topercentage by volumes at 15.560c.Temperature: Unless otherwise specified all temperatures refer to centigrade (Celsius),thermometric scale and all measurement are made at 250.Solutions: Unless otherwise specified in the individual monograph, all solutions areprepared with Purified Water.Reagents and Solutions: Reagents required for the assay and tests of the Pharmacopoeiaare defined in the Appendix showing the nature, degree of the purity and strength ofsolutions to be made from them.Filtration: Where it is directed to filter, without further qualification, it is intended thatthe liquid be filtered through suitable filter paper or equivalent device until the filtrate isclear.Soluble substances: The following table indicates the meaning of degree of solubilities:_____________________________________________________________Descriptive TermsRelative quantities of solvent_____________________________________________________________Very solubleless than 1 partFreely solublefrom 1 to 10 partsSolublefrom 10 to 30 partsSparingly solublefrom 30 to 100 partsSlightly solublefrom 100 to 1000 partsVery slightly solublefrom 1000 to 10,000 partsPractically insolublemore than 10,000 parts_____________________________________________________________The term ‘partly soluble’ is used to describe a mixture of which only some of thecomponents dissolve.Therapeutic uses: Therapeutic uses of the formulations mentioned in thisPharmacopoeia are as given in the Ayurvedic Formulary of India.Doses: The doses mentioned in each monograph are in metric system which are theapproximate conversions from classical weights mentioned in Ayurvedic texts.