GENERAL METHOD FOR PESTICIDE RESIDUES ANALYSIS Definition— Where ud in this Pharmacopeia,the designation pesticideapplies to any substance or mixture of substances intended to prevent,destroy,or control any unwanted species of plants or animals causing harm during or otherwi interfering with the production,processing,storage,transport,or marketing of pure articles.The designation includes substances intended for u as growth regulators,defoliants,or desiccants,and any substance applied to crops before or after harvest to protect the product from deterioration during storage and transport. Limits— Within the United States,many botanicals are treated as dietary supplements and are subject to the statutory provisions of the Federal Food,Drug,and Cosmetic Act that governs foods but not drugs.Limits for pesticides for foods are determined by the Environmental Protection Agency (EPA),and where no limit is t,the limit is zero.The limits contained herein,therefore,are not applicable in the United States when articles of botanical origins are labeled for food purpos.The limits,however,may be applicable in other countries where the prence of pesticide residues is permitted.Unless otherwi specified in the individual monograph,the article under test contains not more than the amount of any pesticide indicated inTable 3.The limits applying to pesticides not listed in Table 3and who prence is suspected for any reason comply with the regulations of the EPA.Where a pesticide is not listed in Table 3or in EPAregulations,calculate the limit by the formula: AM/100B, in which Ais the acceptable daily intake (ADI),in mg per kg of body weight;Mis the body weight,in kg;and 秘书长英文Bis the daily do of the article,in kg. Table 3
If the article is intended for the preparation of extracts,tinctures,or other pharmaceutical forms who preparation method modifies the content of pesticides in the finished product,calculate the limits by the formula: AME/100B, in which Eis the extraction factor of the preparation method,determined experimentally;and A,M,and Bare as defined above. Sampling— Method— For articles in containers holding less than 1kg,mix the contents,and withdraw a quantity sufficient for the tests.For articles in containers holding between 1and 5kg,withdraw equal portions from the upper,middle,and lower parts of the container,each of the samples being sufficient to carry out the tests.Thoroughly mix the samples,and withdraw an amount sufficient to carry out the tests.For containers holding more than 5kg,withdraw three samples,each weighing not less than 250g,from the upper,middle,and lower parts of the container.Thoroughly mix the samples,and withdraw a portion sufficient to carry out the tests. 石碳酸Size of Sampling— If the number of containers,n,is three or fewer,withdraw samples from each container as indicated above.If the number of containers is more than three,take samples from containers,rounding up to the nearest whole number if necessary. NOTE—Conduct tests without delay to avoid possible degradation of the residues.If this is not possible,store the samples in hermetic containers suitable for food contact,at a temperature below 0,and protected from light. Reagents— U reagents and solvents that are free from any contaminants,especially pesticides,that might interfere with the analysis.It is often necessary to u special grade solvents suitable for pesticide residue analysis or solvents that have recently been redistilled in an apparatus made entirely of glass.In any ca,suitable blank tests must be performed. Preparation of Apparatus— Clean all equipment,especially glassware,to ensure that it is free from pesticides.Soak all glassware for a minimum of 16hours in a solution of phosphate-free detergent,rin with copious quantities of distilled water,and then wash with acetone,followed by hexane or heptane. Qualitative and Quantitative Analysis of Pesticide Residues— U validated analytical procedures that satisfy the following criteria.The method,especially with respect to its purification steps,is suitable for the combination of pesticide residue and substance under test,and is not susceptible to interference from co-extractives.Measure the limits of detection and quantification for each pesticide matrix combination to be analyzed:the method is shown to recover between 70%and 110%of each pesticide;the repeatability and reproducibility of the method are not less than the appropriate values indicated in Table 4;and the concentrations of test and reference solutions and the tting of the apparatus are such that a linear respon is obtained from the analytical detector. Table 4
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