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Friday, July 3, 2009

and using sodium solution FP suitably diluted with water as the standard solution ANTISERA

fibnnogen. For sodium ions- To 10.0 ml of the solution add sufficient water to produce 100.0 mlH dilute 100 ml lo 500 D ml with water and determine the content of sodium ions by Method B for flame photometry, Appendix 5.1, measuring at about 689 rim. and using sodium solution FP suitably diluted with water as the standard solution ANTISERA. Immunosera Antisera are natrve (unconcentrated) sera or preparations from native sera containing specific immune globulins that have proph^acbc or therapeutic action when injected into persons exposed to or suffering from a disease caused by a specific micro-organism. Antisera are prepared by injecting, antigens which are preparations of cultures of the specific organisms or venoms or their products into healthy humans or animals such as horses so as to produce in them antibodies which are normally associated with the globulin fraction of serum. Antigens commonly used for this purpose are toxins, toxoids. venoms and bactenai and viral Vaccines. Non-lethal amounts of ttie toxin or the corresponding to/aid//ace me are rnjected ingradually increasing doses into animals. Specific antitoxins are formed in the serum and the animals become active^ immune During [fie process of immunisation, the animals should not be treated with penicillin. When a satisfactory degree of the immunity is produced, larger volumes of blood are withdrawn from the animals and the plasma or serum is processed to produce specific antisera. The globulins may be obtained (rom [he immune serum by enzyme treatment and fractional precipitation or by other physical or chemical methods.Antiviral sera with the exception of Rabies Anliserum are usualty1 obtained from the plasma or serum of human patients who have recovered from me viral disease or who have been artrficialty immunised. Rabies Antiserum is obtained from animals by injecting gradually increasing doses of a rabies vaccine, a killed vaccine being used first and when some immunity is established living virus being used as an antigen. When sufficient virus -neutral ising Dtre is reached the blood is collected and processed Antisera issued in liquid form are distributed under aseptic conditions into stenle containers which are then sealed so as to exclude micro-organisms. A suitable antibacterial substance may be added and is invanably added when the final product is filled in multiple dose containers. The product may be freeze-dned by a procedure which reduces the water content of the final product to less than 1.0% w/w. Antisera are almost colourless or very faintly yellow liquids free from turbidity. Freeie-dned antisera consist of white or pale-yellow powders or friable masses which dissolve in water to form colourless or pale yellow liquids having the same charadensbcs as the corresponding liquid preparations Storage. Antcsera should be stored at a temperature between 2" and 8* and should not be allowed to freeze unless otherwise stated in the individual monograph. Labelling; The label states the name and quantity of antibacterial substance added, if any STANDARDS The following requirements refer to liquid antisera and to the reconsttuted freeze-dned preparations pH. Between 6.0 and 7.0. Appendix 8.11. Total protein; Not more than 17.0% w/v. determined by carrying out the determination of nitrogen, Method C, Appendix 3.20, and multiplying the result by 6.25 Foreign proteins: When examined by precipitation reactions with specific antisera. they are shown to consist exclusivey of protein of the declared anrmal species. Phenol (if present) Not more man 0.25% w/v. Appendix 3.21 Stenlity Comply with the tests for sterility, Appendix 9.5.Abnormal toacity Comply with the rest for abnormal toxicrty, Method B. Appendix 2.2. in antisera containing phenol as preservative, me test in mice may be inappropriate NQTE-The statements given in this general monograph are intended to be read in conjunction with the monographs on the individual antiserum in the Pharmacopoeia which refer to preparations for human use, they do not necessarily apply to antisera for use in veterinary practiceARACHiS OIL Groundnut Oil. Peanut Oil Arachis Oil is the refined fixed oil obtained from the seed kernels of one or more of the cultivated varieties of Arachis hypogaea Linn (Fam. Legummosae) and may contain surtabie antioxidants as stabilisers Category Pharmaceuncal aid (oleogenous vehicle) Oescnption Clear, colourless or pale yellow oity liquid, odour, faint and nutlike Solubility Very slightly soluble in ethanol (95%). Miscible with ether, with chloroform and with light petroleum (boiling range 40* to 60*)Storage Store in well-filled, well-closed, light-resistant containers Arachis Oil intended for use in the manufacture of mjectable preparations should be stored in a glass container Labelling. The label states (1) whether

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