Comprehensive certificate of analysis cheap reglan 10 mg with visa gastritis diet forum, Certificate of business incorporation with the corporate affairs commission in Nigeria proven reglan 10mg gastritis symptoms back. Labelling should be informative and accurate consisting of name of product, batch number, brand name, date of manufacture, location address of manufacturer, distributor, packer, importer, exporter, net content of essential ingredients in metric units which must be listed by their common names and must contain directions for safe use. Graphic design of drug package, and first of all, its labelling strongly influences competitiveness of pharmaceutical enterprises and plays critical role in preventing medication errors what is much more important. The latter are attributed to confusing, complex and unwieldy information design on drug package. Hence, improved design of a drug package can reduce this situation and also increase medication compliance, especially among older patients. Nowadays a lot of guidelines and standards are implemented to make package design, first of all, patient-centred. It means that design solutions acceptable for pharmacists to choose the correct pack from crowded shelves may not be so suitable for some categories of patients. The objective of the present research is to study modern approaches and recommendations to graphic design of drug packages. Different information data including guidelines, standards, journal articles and Internet sources concerning principles of labelling on primary (mainly blisters) and secondary packages have been analyzed. When creating the design for pharmaceutical package, it is important to pay great attention on complex of labelling elements: colours, dimensions, allocation, typography, font formatting, trade names, identity of the manufacturer. Colour is an important factor to make correct identification, classification and differentiation of medicines, but if improper it can cause many problems. Rendering the same colour design for a whole manufacturer‘s range of drugs can lead to confusing of different medicines resembling each other in their colours. This risk increases if drugs with similar names or with the same name but differ in dosage are stored close to each other in pharmacy, hospital or patient‘s home. Proper colour differentiation facilitates distinguishing drugs within manufacturer‘s range, especially between different dosages of the same drug. Text on every side of a secondary package should be oriented in the same direction. Images and trademarks should be printed aside from the relevant text, because placing the latter around or over graphics reduces legibility of information. The most critical information (drug name, dosage, form, quantity of a drug) should appear in the same field of view on at least three non-opposing sides of a secondary package. Blank space can be used to great effect and to emphasize this critical information Generic name of a drug should be preferably emphasized and presented consistently in large point size, at least 16 point or larger. Where patients have different brand names of the same drug, they may confuse its brand and generic names. Many medication errors made by pharmacists, doctors and patients arise from look-alike and sound-alike drug labelling and names, also confusing or unclear information. They may also arise if a medical product is physically difficult to handle or use as intended for patients. To solve this problem it‘s recommended to use capital lettering emphasizing the difference between look-alike and sound-alike drug names (e. If a drug is produced in several dosages it‘s very important to provide differentiation between strengths of the same drug. This can be made clear through use of different typefaces, font colour and shape and especially background colour. There are also useful design recommendations for some primary packages – blisters, strips. To enhance readability and identification of a drug withdrawn from secondary package non-reflective, matt, printed and coloured foils should be used. The primary and secondary packaging of a drug should have an identical (or linked) distinctive visual style (e. Proper design of package and labelling of drugs is one of the ways to eliminate most of the risks associated with medication errors occurring on all stages of drug turnover: in pharmacies, warehouses, hospitals, patient‘s home. Most of the abovementioned recommendations are not mandatory yet, but in future they should be guidance for designers, manufacturers and authorized bodies to establish standardized rules to the package design that can strongly influence on the safe use of drugs. Medicinal immunobiological preparations and, in particular, vaccines, serums, anatoxin, antigens, etc. Great range of different equipment and system types has been developed for their transportation and storage. There are a lot of manuals and guidelines concerning their proper use, because it‘s very responsible process. Transporting, storage and handling errors can cost thousands of dollars in wasted vaccine and need for revaccination. Errors can also result in the loss of patient confidence when repeat doses are required Aim. The objective of the present article is study of conditions for transportation of immunobiological preparations, in particular vaccines, in cold chain system. In the present study different information data sources including normative documentation concerning principles and methods of transportation of immunobiological preparations have been analyzed. To maintain appropriate storage and transportation conditions for vaccines from manufacturer to medical or pharmaceutical institutions there should be used cold chain system consisting of: - personnel providing medical aid and refrigerating machinery services; - procedures used to control distribution and use of vaccines; - equipment itself which should conform the requirements for safe storage eliminating dependence on environment and various surrounding factors. To protect vaccines one should use thermocontainers and portable transferring bags where special cards-indicators & freeze indicators are placed into, providing necessary control over regimens of transportation. Thermocontainers as well as transferring bags have a cover tightly closing them, and also they have heat-insulating properties, the difference is only in that transferring bag is much less in its sizes. Charging of thermocontainers with preparations is carried out in fridge storage rooms (premises for vaccine storage) or under exceptional situations at ambient temperature if duration of charging does not exceed 10 minutes. Onto 306 a box for vaccines, anatoxins, tubercular allergen which do not allow freezing a label with inscriptions ―Vaccine! On the 1st and 2nd levels of transportation of immunobiological preparations from a manufacturer to a wholesale storage warehouse on large distances during 1–3 days it‘s necessary to use refrigerator transport vehicles with temperature from +2 to +8°С. On the 2nd level an authorized person should have coordinated supply schedule of immunobiological preparations to the 3rd level and should supervise their remaining shelf-life which should be not less than 1 month at the moment of shipment. Transporting from the 3rd to the 4th level (to treatment-prophylactic establishments) is carried out in thermocontainers. At obtaining of vaccines, anatoxins, tubercular allergen they should be immediately placed into refrigerating machinery and indications of control means should be checked. Important parameter during transportation and storage of immunobiological preparations is duration of cold preservation inside equipment which is defined by time during which this equipment preserves temperature not above +10 °С. There are some factors which this time depends on: - type of a portable transferring bag, materials of which it is produced, thickness of its walls; - temperature under which a cooling element has been placed into a container, and also weight of a vaccine; - exposure time when a container was kept opened; - environment, namely air temperature. The complete set of the equipment for transportation of immunobiological preparations includes refrigerating elements (packets). For temperature maintenance within range from 0 to +8 ºС also such frozen cooling packets are used. During transportation in deep-freezer it‘s necessary to keep the second complete set of refrigerating elements and while the first complete set is used, the second one should be kept in frozen state. Vaccines must be transported and stored properly under cold chain from the time they are manufactured until they are administered.

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For multiple related changes product testing to a single analytical laboratory for which the recommended reporting categories for the at a manufacturing site reglan 10 mg discount gastritis diet . Some of the products that will be Active Ingredient/Drug Substance—Any component that tested at the analytical laboratory when the con- is intended to furnish pharmacological activity or other solidation occurs are not solid oral dosage form direct effect in the diagnosis buy reglan without prescription gastritis relieved by eating, cure, mitigation, treatment, or products. Unlike most other production opera- prevention of a disease, or to affect the structure or any tions, testing laboratories are not inspected on function of the human body, but does not include interme- a dosage form/type of drug substance-specific diates used in the synthesis of such ingredient, including basis. For Final Intermediate—The last compound synthesized example, certain changes in the container closure systems before the reaction that produces the drug substance. The of solid oral dosage form products may be included in the final step forming the drug substance must involve cova- annual report, as long as the new package provides the lent bond formation or breakage; ionic bond formation same or better protective properties and any new primary (i. For drug substance, in-process reliable sources of information to determine that the com- materials are considered those materials that are undergo- ponent or material has been used in and has been in contact ing change (e. Manufacturing (process and equipment) Definition of level 1 changes are those that are unlikely 3. Scale up/scale down of manufacture to have any detectable effect on formulation quality and 4. Deletion or partial deletion of an ingredient It is important to define intended to affect the color, fragrance, or flavor of the drug product. The total controls tests to support each level of change additive effect of all excipient changes should 3. Changes in the compo- bioequivalence tests to support each level of sition should be based on the approved target change composition and not on previous level 1 4. For scale- entity (purity 95%) or change in a supplier or up and postapproval changes submissions, the following technical grade of any other excipient. In most cases, except those involving scale up, significant effect on formulation quality and performance. Changes of >5% and <10% of approved potency loss or degradant increase under amount of an individual excipient; the total accelerated conditions, it is recommended that additive effect of all excipient changes should historical accelerated stability data from a rep- not be more than 10% resentative prechange batch be submitted for B. It is also recommended that under on the approved target composition and not on these circumstances, all available long-term previous level 1 or level 2 changes in the com- data on test batches from ongoing studies be position provided in the supplement. Change in supplier of a structure forming long-term stability studies through the expiration excipient not covered under level 1 17 18 Handbook of Pharmaceutical Manufacturing Formulations: Semisolid Products E. Change in the technical grade of structure- changes should be properly validated and may be inspected forming excipient by appropriate agency personnel. Change in particle size distribution of the drug size are those up to and including a factor of 10 times the substance if the drug is in suspension size of the pivotal clinical trial or biobatch, where the equipment used to produce the test batch or batches is of Definition of level 3 changes are those that are likely to the same design and operating principles, the batch or have a significant effect on formulation quality and per- batches are manufactured in full compliance with current formance. Any qualitative and quantitative changes in an the same formulation and manufacturing procedures, are excipient beyond the ranges noted in level 2 used on the test batch or batches and on the full-scale change. Change in crystalline form of the drug sub- are those from beyond a factor of 10 times the size of the stance, if the drug is in suspension pivotal clinical trial or biobatch, where the equipment used to produce the test batch or batches is of the same design and operating principles, the batch or batches is manufac- I. If any quantitative facturing procedures, are used on the test batch or batches or qualitative changes are made in the formulation, addi- and on the full-scale production batch or batches. A level tions, or testing for both company-owned and contract 1 change is a change from nonautomated or nonmechan- manufacturing facilities, and they do not include any other ical equipment to automated or mechanical equipment to level 2 or 3 changes; for example, changes in scale, man- transfer ingredients or a change to alternative equipment ufacturing (including process or equipment), and compo- of the same design and operating principles. A stand-alone analytical testing labora- equipment, such as high shear to low shear and vice versa. No stability data are needed for a change in a ranges for all dosage forms in addition to any changes in stand-alone analytical facility. No level 3 changes site changes within a single facility where the same equip- are anticipated in this category. All scale campus who have suitable experience with the manufacturing Postapproval Changes to Semisolid Drugs 19 process. Level 2 changes consist of site changes within a same original contiguous site or where the facilities are contiguous campus, or between facilities in adjacent city not in adjacent city blocks. Changes should not be made to the manu- used, and where no changes are made to the manufacturing facturing batch records except when consistent with other batch records, except for administrative information and level 1 changes. Scale-Up and Postapproval 3 Changes for Nonsterile Semisolid Dosage Forms: Manufacturing Equipment I. Particle Size Reduction (particle size reduction or separation, mixing, emulsifica- tion, deaeration, transfer, and packaging). The mechanical process used is subclass are considered to have the same design and generally referred to as milling. Particle etary mixer from manufacturer A to another planetary A particle is either a discrete crystal or a grouping of mixer from manufacturer B would not represent a change crystals, generally known as an agglomerate. A change from equipment in one class to equipment • Impact—Particle size reduction caused by apply- in a different class would usually be considered a change ing an instantaneous force perpendicular to the in design and operating principle. For example, a change particle or agglomerate surface; the force can from a planetary mixer to a dispersator mixer demon- result from particle-to-particle or particle-to-mill strates a change in operating principle from low-shear surface collision convection mixing to high-shear convection mixing. In many situa- • Cutting—Particle size reduction by applying a tions, these changes in equipment would be considered shearing force to a material similar. Particle Separation mixer (subclass) to a planetary mixer (subclass) repre- Particle separation is particle size classification according sents a change within a class and between subclasses. Provided the manufacturing process with the new equip- ment is validated, this change would likely not need a 2. Fluid Energy Milling scientific data and rationale used to make this determi- Fluid energy milling is particle size reduction by high- nation. It is up to the applicant to determine the filing speed particle-to-particle impact or attrition (also known category. Compression Mills Particle size reduction by high-speed mechanical impact Although compression mills, also known as roller mills, or impact with other particles (also known as milling, can differ in whether one or both surfaces move, no com- pulverizing, or comminuting) is known as impact milling. Compression Milling Screening mill subclasses primarily differ in the rotating Particle size reduction by compression stress and shear element. Screening • Rotating impeller Particle size reduction by mechanically induced attrition • Rotating screen through a screen (commonly referred to as milling or deagglomeration) is called screening. Tumble Milling Tumbling mill subclasses primarily differ in the grinding Tumble milling is particle size reduction by attrition, using media used and whether the mill is vibrated. Separating • Rod media Particle segregation based on size alone, without any sig- • V ibrating nificant particle size reduction (commonly referred to as screening or bolting), is also known as separating. Fluid Energy Mills • Centrifugal Fluid energy mill subclasses have no moving parts and • V ibratory or shaker primarily differ in the configuration or shape of their chambers, nozzles, and classifiers. Please note that if a single piece of equipment is capable of performing multiple discrete unit operations, it has been • Fixed target evaluated solely for its ability to affect particle size or • Fluidized bed separation. Impact Mills Mixing is the reorientation of particles relative to one Impact mill subclasses primarily differ in the configura- another to achieve uniformity or randomness. This process tion of the grinding heads, chamber grinding liners (if can include wetting of solids by a liquid phase, dispersion any), and classifiers. Heating and cooling via indirect conduction may • Cage be used in this operation to facilitate phase mixing or • Hammer air swept stabilization.

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Any interested person (f) The terms and conditions of the who accepts the invitation to partici- permit may be modified at the discre- pate in the extended market test shall tion of the Food and Drug Administra- notify the Food and Drug Administra- tion or upon application of the per- tion in writing of that fact effective 10 mg reglan gastritis antibiotics, the amount mittee during the effective period of to be distributed generic 10 mg reglan with visa gastritis symptoms palpitations, and the area of dis- the permit. The application for an extension shall be Subpart B—Food Additives in filed not later than 3 months prior to Standardized Foods the expiration date of the permit and shall be accompanied by a petition to §130. If use in foods for which definitions the Food and Drug Administration con- and standards of identity are estab- cludes that it will be in the interest of lished. Cream contains not less than 18 posal for a food additive regulation, percent milkfat. Milk is the lacteal se- culated by subtracting the milk fat cretion, practically free from colos- content from the total solids content trum, obtained by the complete milk- as determined by the method "Total ing of one or more healthy cows. Milk Solids, Method I—Official Final Ac- that is in final package form for bev- tion," section 16. The name of the food by separating part of the milkfat shall be accompanied on the label by a therefrom, or by adding thereto cream, declaration indicating the presence of concentrated milk, dry whole milk, any characterizing flavoring, as speci- skim milk, concentrated skim milk, or fied in §101. The word national Units thereof within limits of "vitamin" may be abbreviated "vit. Each of the in- (i) Fruit and fruit juice (including gredients used in the food shall be de- concentrated fruit and fruit juice). I (4–1–10 Edition) One or more of the other optional in- sirup; malt extract, dried malt extract; gredients specified in paragraphs (b) malt sirup, dried malt sirup; honey; and (e) of this section may also be maple sugar; or any of the sweeteners added. When one or more of the ingre- listed in part 168 of this chapter, except dients specified in paragraph (e)(1) of table sirup. All in- (4) Color additives that do not impart gredients used are safe and suitable. The following such quantity that each 946 milliliters referenced methods of analysis are (quart) of the food contains not less from "Official Methods of Analysis of than 2,000 International Units thereof, the Association of Official Analytical within limits of good manufacturing Chemists," 13th Ed. The name of the brown sugar; refiner’s sirup; molasses food is "acidified milk". The full name (other than blackstrap); high fructose of the food shall appear on the prin- corn sirup; fructose; fructose sirup; cipal display panel of the label in type maltose; maltose sirup, dried maltose of uniform size, style, and color. The food may be homogenized such as a traditional name of the food and shall be pasteurized or ultra-pas- or the generic name of the organisms teurized prior to the addition to the used, thereby indicating the presence microbial culture, and when applicable, of the characterizing microbial orga- the addition of flakes or granules of nisms or ingredients when used, e. Cream, min A added", or "vitamin D" or "vi- milk, partially skimmed milk, or skim tamin D added", or "vitamins A and D milk, used alone or in combination. Each of the in- tein efficiency ratio of all protein gredients used in the food shall be de- present, shall not be decreased as a re- clared on the label as required by the sult of adding such ingredients. Cultured milk is the malt sirup, dried malt sirup; honey; food produced by culturing one or more maple sugar; or any of the sweeteners of the optional dairy ingredients speci- listed in part 168 of this chapter, except fied in paragraph (c) of this section table sirup. One or more of the other op- (4) Color additives that do not impart tional ingredients specified in para- a color simulating that of milkfat or graphs (b) and (d) of this section may butterfat. The following ters used in such name: referenced methods of analysis are (i) The phrase "vitamin A" or "vita- from "Official Methods of Analysis of min A added", or "vitamin D" or "vi- the Association of Official Analytical tamin D added", or "vitamin A and D Chemists," 13th Ed. The full name added, vitamin D shall be present in of the food shall appear on the prin- such quantity that each fluid ounce of cipal display panel in type of uniform the food contains 25 International size, style, and color. The name of the Units thereof, within limits of good food shall be accompanied by a declara- manufacturing practice. The following characterizing flavoring as specified in safe and suitable optional ingredients §101. Referenced and (9) of this section, and lactic acid- methods are from "Official Methods of producing organisms are used the food Analysis of the Association of Official may be named "cultured buttermilk". The milkfat codeloflfederallregulations/ content is determined by the method ibrllocations. Final Action," which is incorporated (3) Vitamin D content—"Vitamin D by reference. The name of the food shall include a declaration of the presence of include a declaration of the presence of any characterizing flavoring, as speci- any characterizing flavoring, as speci- fied in §101. Each of the in- gredients used in the food shall be de- gredients used in the food shall be de- clared on the label as required by the clared on the label as required by the applicable sections of parts 101 and 130 applicable sections of parts 101 and 130 of this chapter. Nonfat dry milk is the milk is the food obtained by partial re- product obtained by removal of water moval of water only from a mixture of only from pasteurized skim milk. It milk and safe and suitable nutritive contains not more than 5 percent by carbohydrate sweeteners. The finished weight of moisture, and not more than food contains not less than 8 percent 11⁄2 percent by weight of milkfat unless by weight of milkfat, and not less than otherwise indicated. The quantity of nutritive carbo- able characterizing flavoring ingredi- hydrate sweetener used is sufficient to ents (with or without coloring and nu- prevent spoilage. The food is pasteur- tritive carbohydrate sweetener) as fol- ized and may be homogenized. The following contains 2000 International Units referenced methods of analysis are thereof. The following (1) Milkfat content—"Fat in Dried safe and suitable optional ingredients Milk—Official Final Action," sections may be used: 16. If the fat 1 (i) Fruit and fruit juice, including content is over 1 ⁄2 percent by weight, concentrated fruit and fruit juice. The following milkfat", the blank to be filled in with referenced methods of analysis are the percentage to the nearest one- from "Official Methods of Analysis of tenth of 1 percent of fat contained, the Association of Official Analytical within limits of good manufacturing Chemists," 13th Ed. The name of (ii) Natural and artificial food fla- the food shall include a declaration of voring. Each of the in- the Association of Official Analytical gredients used in the food shall be de- Chemists," 13th Ed. Evaporated milk is codeloflfederallregulations/ the liquid food obtained by partial re- ibrllocations. Evaporated (3) Vitamin D content—"Vitamin D milk contains added vitamin D as pre- in Milk—Official Final Action," sec- scribed by paragraph (b) of this section. The name of the tainer and so processed by heat, either food is "Evaporated milk. The name of the food shall such quantity that each fluid ounce of include a declaration of a the presence the food contains not less than 125 of any characterizing flavoring, as International Units thereof within lim- specified in §101. The following gredients used in the food shall be de- safe and suitable ingredients may be clared on the label as required by the used: applicable sections of parts 101 and 130 (1) Carriers for vitamins A and D. Dry whole milk is the product obtained by removal of water (d) Methods of analysis. The following only from pasteurized milk, as defined referenced methods of analysis are in §131. Alternatively, dry whole the Association of Official Analytical milk may be obtained by blending Chemists," 13th Ed. It codeloflfederallregulations/ contains not less than 26 percent but ibrllocations. It contains Milk—Official Final Action," sections not more than 5 percent by weight of 16. The cording to label directions, each quart name of the food shall be accompanied of the reconstituted product shall con- by a declaration indicating the pres- tain 400 International Units thereof. The graph will be met if reasonable over- following phrases in type size not less ages, within limits of good manufac- than one-half the height of the type turing practice, are present to ensure size used in such name shall accom- that the required levels of vitamins are pany the name of the food wherever it maintained throughout the expected appears on the principal display panel shelf life of the food under customary or panels.

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Now buy reglan 10 mg with visa gastritis morning nausea, when an equilibrium is established buy cheap reglan 10 mg online gastritis dietitian, the percentage bound is given by the expression, : (A – P + A* – P) 100 200 100 A*− P 100 × = × Total (A + A*) 1 300 1 Total A * 1 120 100 or = × = 66. However, this particular condition may be tested and verified by making multiple dilutions of an unknown sample and subsequently determining whether the curve of competitive inhibition of binding is superimposable on the standard curve employed for the respective assay. Failure to fulfill this condition precludes a truly quantitative estimation+, and (c) A crude hormone preparation is found to be satisfactory enough both for immunization and for use as a standard, but for the purpose of comparison of values collected from various laboratories, a generally available reference preparation must be used as a standard solution. However, the former type is preferred because of the fact that here the pellet is formed at the bottom of the test tube and the supernatant layer is more easily removed in comparison to the latter type where the pellet is formed at an angle. In case, a centrifuge having relatively less gravitational force is employed then it is absolutely necessary to enhance the centrifugation time until suitable pellets are formed duly. Gamma Counters These are used invariably for the gamma-energy emitting isotopes, for instance : 125I-the more com- mon iodine-isotope. Scintillation Counters These are mostly used for counting beta-energy-emitting isotopes, such as : tritium 3H and 14C-(Carbon-14) isotopes. First and foremost, radioimmunoassays were universally based on the 3H or 14C isotope labelling tech- nique, but this has the main disadvantage of using liquid-scintillation counting. Therefore, the comparatively much simpler technique of gamma-ray counting by labelling compounds with 124I, 125I, or 131I is now being increasingly utilized wherever such labelling is practically feasible. Hence, the experimental condi- tions of incubation of standards and unknowns must be identical for any factors that might affect the extent of the immunochemical reaction, pH, ionic composition, protein content or any other substances of inter- est. However, these conditions may be tested conveniently and can be controlled effectively by preparing standards in hormone free plasma at the same dilution at which unknowns are assayed. It has attained wide recognition and application both in vitro andin vivomeasurements of compounds of interest like insulin, gastrin, glucagon, and growth hormones on one hand ; whereas drugs like : Morphine — Narcotic analgesic, Hydromorphone and — Narcotic analgesic, antitussive and antipyretic, Hydrocodone on the other hand. The mixture is incubated overnight at room temperature and then dialyzed against distilled water to cause purification. The resulting purified product carboxy-methyl-bovine-serum conjugate is then labelled with tritium. Antiserum Production : The immunogen, carboxymethylmorphine-bovine-serum-albumin, is emulsi- fied with equal volume of complete Freund’s adjuvant*. Initial immunization doses are injected into the New Zealand albino rabbits and later on this followed up with booster injections after a period of 6 weeks. The antiserum titer is determined with each booster dose injection and is duly harvested when the titre value is maximum. However, interest in the pharmacokinetics of hydromorphone and hydrocodone in human subjects required an adequate assay for drug levels in plasma. The free-drug is separated from bound drug using dextran coated charcoal and an aliquot of the supenate containing the antiserum-bound-drug is subsequently counted for radioactivity. However, the radioactivity measurements are normally ascertained in a Liquid Scintillation Counter provided with 20-ml glass scintilla- tion vials. Materials Required (i) Lyophilized morphine-6-antiserum : It is diluted 1 : 20 with phosphate buffer prior to use, (ii) 3H-Dihydromorphine Solution : It is prepared by diluting 2 µl of the radiolabelled compound in ethanol to 10 ml with phosphate buffer so that each 0. Dilutions of the drugs are made in individual 10 ml volumetric flasks to yield drug concentrations of 2. After successive dialysis against dioxane-water borate buffer and water, the immunogen i. Preparation of 3H-Labelled Clonazepam : 3H-Clonazepam is prepared by tritium exchange employ- ing dimethyl formamide-titrated water having a specific activity*** of 100 ci g–1. The resulting product is subsequently purified by silica-gel-column-chromatography, thereby yielding a material which has a specific activity of 4. This specific method of introducing3H (tritium) probably provided exchange chiefly at C-3 position****. Antibody Production :A thick emulsion of the immunogen (clonazepam-bovine-serum-albumin-con- jugate) is prepared employing complete Freund’s adjuvant and two New Zealand white female rabbits are immunized intradermally at multiple sites with the immunogen emulsion. Both rabbits produced satisfactory titers of antibodies to clonazepam within a period of three months following the initial immunization. The resulting serum is pooled, diluted suitably and employed in the radioimmunoassay. It is coupled covalently to bovine-serum-albumin by the mixed-anhydride procedure developed by Erlanger et al (1959). The resulting conjugate is purified by dialysis against sodium bicarbonate solution followed by dialy- sis against distilled water and finally isolated by lyophilization. Immunization and Antibody Production : The immunogen 3-hemisuccinyloxyflurazepam, is emulsi- fied with complete Freund’s adjuvant. Subsequently, booster injections of the thick-immunogen-emulsion-paste are administered after a span of 6-weeks. The mono-as well as di-desethylmetabolites exhibited a cross-reactivity of 17 and 3. The resulting mixture is cooled to -30 °C and isoamyl nitrite in dioxane is added. The solution is stirred at – 30° to – 40 °C and aqueous ammonium sulfamate is added with continuous stirring. The chilled azide solution is added slowly, dropwise with constant vigorous stirring into a solution of bovine-serum albumin. The resulting pale-yellow solution is kept at 4°C for a duration of 36 hours and then dialysed against trimethamine buffer. After further dialysis for two days against distilled water, the immunogen is isolated by lyophilization. Immunization and Antibody Production : The lypphilized immunogen obtained above is dissolved in normal saline and emulsified with equal volumes of complete Freund’s adjuvant into a thick paste. Three New Zealand albino rabbits are immunized with the immunogen-paste through intradermal injections. The process is repeated twice at 2-weeks intervals followed by booster doses at monthly intervals. Specificity of Antibody binding of Chlordiazepoxide : A good number of benzodiazepines are tested for their ability to complete with labelled chlordiazepoxide for the respective antibody binding site. The mixture is incubated overnight at 4°C, and the protein-hapten complex is dialysed against distilled water thereby causing its purification. Six weeks after the initial does, booster doses are administered to the animals in each of their foot pads. Blood samples are collected 5-7 days after the booster injections and the serum is examined for antibodies to barbiturates. The antiserum is harvested when the serum antibody titer has attained its maximum level. It has been observed that while normal, rabbit serum failed to bind labelled phenobarbital, the serum from immunized rabbits bound 75 to 80% of the added pentobarbital and there exists a linear relationship between 14C-phenobarbital and the concentration of added antibody. Besides, when variable quantities of 14C- pentobarbital are added to a constant quantity of antibody, there exists a linear relationship between added and bound 14C-phenobarbital as depicted in Figure 32. Hence, there is a dire need for a sensitive method of plasma concentration evaluation which is satisfied by radioimmunoassay.