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类型美国药典(USP34)附录-115英文.doc

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    1、115 DEXPANTHENOL ASSAY The following procedure is provided for the determination of dexpanthenol as an ingredient of multiple-vitamin preparations. It is applicable also to the determination of the dextrorotatory component of racemic panthenol and of other mixtures containing dextrorotatory pantheno

    2、l.Media may be prepared as described hereinafter, or dehydrated mixtures yielding similar formulations may be used provided that, when reconstituted as directed by the manufacturer or distributor, they have growth-promoting properties equal to or superior to those obtained from the formulas given he

    3、rein.USP Reference Standards 11 USP Dexpanthenol RS. Standard Stock Solution of Dexpanthenol Dissolve an accurately weighed quantity of USP Dexpanthenol RS in water, dilute with water to obtain a solution having a known concentration of about 800 g per mL, and mix. Store in a refrigerator, protected

    4、 from light, and use within 30 days. Standard Preparation On the day of the assay, prepare a water dilution of the Standard Stock Solution of Dexpanthenol to contain 1.2 g of dexpanthenol per mL. Assay Preparation Proceed as directed in the individual monograph for preparing a solution expected to c

    5、ontain approximately the equivalent of the dexpanthenol concentration in the Standard Preparation. Modified Pantothenate Medium Acid-Hydrolyzed Casein Solution 25 mLCystineTryptophane Solution 25 mLPolysorbate 80 Solution 0.25 mLDextrose, Anhydrous 10 gSodium Acetate, Anhydrous 5 gAdenineGuanineUrac

    6、il Solution 5 mLRiboflavinThiamine HydrochlorideBiotin Solution 5 mLPara-aminobenzoic AcidNiacinPyridoxine Hydrochloride Solution5 mLSalt Solution A 5 mLSalt Solution B 5 mLPyridoxal-Calcium Pantothenate Solution 5 mLPolysorbate 40Oleic Acid Solution 5 mLDissolve the anhydrous dextrose and sodium ac

    7、etate in the solutions previously mixed, and adjust with 1 N sodium hydroxide to a pH of 6.8. Finally, dilute with water to 250 mL, and mix.Double-Strength Modified Pantothenate Medium Prepare as directed under Modified Pantothenate Medium, but make the final dilution to 125 mL instead of 250 mL. Pr

    8、epare fresh. Acid-Hydrolyzed Casein Solution Mix 100 g of vitamin-free casein with 500 mL of 6 N hydrochloric acid, and reflux the mixture for 8 to 12 hours. Remove the hydrochloric acid from the mixture by distillation under reduced pressure until a thick paste remains. Redissolve the resulting pas

    9、te in about 500 mL of water, adjust the solution with 1 N sodium hydroxide to a pH of 3.5 0.1, and add water to make 1000 mL. Add 20 g of activated charcoal, stir for 1 hour, and filter. Repeat the treatment with activated charcoal. Store under toluene in a refrigerator at a temperature not below 10

    10、 . Filter the solution if a precipitate forms during storage. CystineTryptophane Solution Suspend 4.0 g of L-cystine and 1.0 g of L-tryptophane (or 2.0 g of D,L-tryptophane) in 700 mL to 800 mL of water, heat to 75 5 , and add dilute hydrochloric acid (1 in 2) dropwise, with stirring, until the soli

    11、ds are dissolved. Cool, add water to make 1000 mL, and mix. Store under toluene in a refrigerator at a temperature not below 10 . AdenineGuanineUracil Solution Dissolve 200 mg each of adenine sulfate, guanine hydrochloride, and uracil, with the aid of heat, in 10 mL of 4 N hydrochloric acid, cool, a

    12、dd water to make 200 mL, and mix. Store under toluene in a refrigerator. Polysorbate 80 Solution Dissolve 25 g of polysorbate 80 in alcohol to make 250 mL, and mix. RiboflavinThiamine HydrochlorideBiotin Solution Prepare a solution containing, in each mL, 20 g of riboflavin, 10 g of thiamine hydroch

    13、loride, and 0.04 g of biotin, by dissolving riboflavin, thiamine hydrochloride, and biotin in 0.02 N acetic acid. Store, protected from light, under toluene in a refrigerator. Para-aminobenzoic AcidNiacinPyridoxine Hydrochloride Solution Prepare a solution in neutral 25 percent alcohol to contain 10

    14、 g of para-aminobenzoic acid, 50 g of niacin, and 40 g of pyridoxine hydrochloride in each mL. Store in a refrigerator. Salt Solution A Dissolve 25 g of monobasic potassium phosphate and 25 g of dibasic potassium phosphate in water to make 500 mL. Add 5 drops of hydrochloric acid, mix, and store und

    15、er toluene. Salt Solution B Dissolve 10 g of magnesium sulfate, 0.5 g of sodium chloride, 0.5 g of ferrous sulfate, and 0.5 g of manganese sulfate in water to make 500 mL. Add 5 drops of hydrochloric acid, mix, and store under toluene. PyridoxalCalcium Pantothenate Solution Dissolve 40 mg of pyridox

    16、al hydrochloride and 375 g of calcium pantothenate in 10 percent alcohol to make 2000 mL, and mix. Store in a refrigerator, and use within 30 days. Polysorbate 40Oleic Acid Solution Dissolve 25 g of polysorbate 40 and 0.25 g of oleic acid in 20 percent alcohol to make 500 mL, and mix. Store in a ref

    17、rigerator, and use within 30 days. Stock Culture of Pediococcus acidilactici Dissolve in about 800 mL of water, with the aid of heat, 6.0 g of peptone, 4.0 g of pancreatic digest of casein, 3.0 g of yeast extract, 1.5 g of beef extract, 1.0 g of dextrose, and 15.0 g of agar. Adjust with 0.1 N sodium

    18、 hydroxide or 0.1 N hydrochloric acid to a pH between 6.5 and 6.6, adjust the volume with water to 1000 mL, and mix. Add approximately 10-mL portions of the solution to culture tubes, place caps on the tubes, and sterilize at 121 for 15 minutes. Cool on a slant, and store in a refrigerator. Prepare

    19、a stock culture of Pediococcus acidilactici* on a slant of this medium. Incubate at 35 for 20 to 24 hours, and store in a refrigerator. Maintain the stock culture by monthly transfer onto fresh slants. Inoculum Inoculate three 250-mL portions of Modified Pantothenate Medium from a stock culture slan

    20、t, and incubate at 35 for 20 to 24 hours. Centrifuge the suspension from the combined portions, and wash the cells with Modified Pantothenate Medium. Resuspend the cells in sufficient Modified Pantothenate Medium so that a 1:50 dilution, when tested in a 13-mm diameter test tube, gives 80% light tra

    21、nsmission at 530 nm. Transfer 1.2-mL portions of this stock suspension to glass ampuls, seal, freeze in liquid nitrogen, and store in a freezer. On the day of the assay, allow the ampuls to reach room temperature, mix the contents, and dilute 1 mL of thawed culture with sterile saline TS to 150 mL.

    22、NOTEThis dilution may be altered, when necessary, to obtain the desired test response. Procedure Prepare in triplicate a series of eight culture tubes by adding the following quantities of water to the tubes within a set: 5.0 mL, 4.5 mL, 4.0 mL, 3.5 mL, 3.0 mL, 2.0 mL, 1.0 mL, and 0.0 mL. To these s

    23、ame tubes, and in the same order, add 0.0 mL, 0.5 mL, 1.0 mL, 1.5 mL, 2.0 mL, 3.0 mL, 4.0 mL, and 5.0 mL of the Standard Preparation. Prepare in duplicate a series of five culture tubes by adding the following quantities of water to the tubes within a set: 4.0 mL, 3.5 mL, 3.0 mL, 2.0 mL, and 1.0 mL.

    24、 To these same tubes, and in the same order, add 1.0 mL, 1.5 mL, 2.0 mL, 3.0 mL, and 4.0 mL of the Assay Preparation. Add 5.0 mL of Double-Strength Modified Pantothenate Medium to each tube, and mix. Cover the tubes with metal caps, and sterilize in an autoclave at 121for 5 minutes. Cool to room tem

    25、perature in a chilled water bath, and inoculate each tube with 0.5 mL of the Inoculum. Allow to incubate at 37 for 16 hours. Terminate growth by heating to a temperature not below 80 , such as by steaming at atmospheric pressure in a suitable sterilizer, for 5 to 10 minutes. Cool, and concomitantly

    26、determine the percentage transmittance of the suspensions, in cells of equal pathlength, on a suitable spectrophotometer, at 530 nm.Calculation Draw a dose-response curve on arithmetic graph paper by plotting the average response, in percent transmittance, for each set of tubes of the standard curve

    27、 against the standard level concentrations. The curve is drawn by connecting each adjacent pair of points with a straight line. From this standard curve, determine by interpolation the potency, in terms of dexpanthenol, of each tube containing portions of the Assay Preparation. Divide the potency of

    28、 each tube by the amount of Assay Preparation added to it, to obtain the individual responses. Calculate the mean response by averaging the individual responses that vary from their mean by not more than 15%, using not less than half the total number of tubes. Calculate the potency of the portion of

    29、 the material taken for assay, in terms of dexpanthenol, by multiplying the mean response by the appropriate dilution factor. * American Type Culture Collection No. 8042 is suitable. Auxiliary Information Please check for your question in the FAQs before contacting USP. Topic/Question Contact Expert CommitteeGeneral Chapter Curtis Phinney 1-301-816-8540(DSN05) Dietary Supplements - Non-BotanicalsReference StandardsLili Wang, Technical Services Scientist1-301-816-8129RSTechusp.orgUSP32NF27 Page 115

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