Example: barber

MONOGRAPHS (USP) - USP–NF | USP-NF

MONOGRAPHS (USP)BRIEFINGA lcohol,USP 27page 59 and page 1699 ofPF29(5) [Sept. Oct. 2003]. The European Pharmacopoeia is the coordinating phar-macopoeia for the international harmonization of compendial stan-dards for theAlcoholmonograph, as part of the process ofinternational harmonization of MONOGRAPHS and general analyticalmethods of the European, Japanese, and United States pharmaco-peias. The following monograph, which represents theADOP-TION STAGE 6document, is based in part on comments fromthe Japanese Pharmacopoeia and the United States Pharmacopeiain response to the Provisional Harmonized Text Stage 5A and 5 Bdrafts prepared by the European Discussion Group Sign-Off DocumentAttributesEPJPUSPI dentification A+++Identification B+++Appearance+++Acidity or alkalinity+++Relative density+++Abs

Standard stock solution—Combine 3.0 mL of ferric chlo-ride CS, 3.0 mL of cobaltous chloride CS, 2.4 mL of cupric sulfate CS, and 1.6 mL of dilute hydrochloric acid (10 g per L). Standard solution—[NOTE—Prepare the Standard solu-tion immediately before use.] Transfer 1.0 mL of Standard stock solution to a 100-mL volumetric flask, dilute ...

Tags:

  Monographs, Chlo

Information

Domain:

Source:

Link to this page:

Please notify us if you found a problem with this document:

Other abuse

Transcription of MONOGRAPHS (USP) - USP–NF | USP-NF

1 MONOGRAPHS (USP)BRIEFINGA lcohol,USP 27page 59 and page 1699 ofPF29(5) [Sept. Oct. 2003]. The European Pharmacopoeia is the coordinating phar-macopoeia for the international harmonization of compendial stan-dards for theAlcoholmonograph, as part of the process ofinternational harmonization of MONOGRAPHS and general analyticalmethods of the European, Japanese, and United States pharmaco-peias. The following monograph, which represents theADOP-TION STAGE 6document, is based in part on comments fromthe Japanese Pharmacopoeia and the United States Pharmacopeiain response to the Provisional Harmonized Text Stage 5A and 5 Bdrafts prepared by the European Discussion Group Sign-Off DocumentAttributesEPJPUSPI dentification A+++Identification B+++Appearance+++Acidity or alkalinity+++Relative density+++Absorbance+++Volatile impurities+++Residue on evapo-ration+++Storage+++Legend:+ will adopt and implement.

2 Will not and Relative density:Each pharmacopeia specifiesa different range for the content; the values for relative density varyaccordingly and, in addition, are expressed at different and reference materials:Each pharmacopeia willadapt the text to take account of local reference substances andspectra and reagent between theADOPTION STAGE 6document andthe currentUSPmonograph include the following:(1) Definition No change.(2)Packaging and storage Storage conditions to protect fromlight are added.(3)USP Reference standards A reference standard for Alcoholis added for use in theIdentificationtest.

3 (4)Identification TestsAandBare replaced with a more defini-tive IR absorption test, and the test for specific gravity ismoved underIdentification.(5)Clarity of solution ThistestisaddedtocomplywithEPstandards.( 6)Color of solution This test is added to comply with EP stan-dards.(7)Specific gravity No change.(8)Acidity This test is replaced by a test forAcidity or alkalinityto comply with EP standards.(9)Limit of nonvolatile residue The sample size is increasedfrom 40 to 100 mL.(10)Water-insoluble substances This test is deleted. Because themonograph contains tests forNonvolatile residueandVolatileimpurities,this test is no longer needed.

4 (11)Aldehydes and other foreign organic substances This test isreplaced with aVolatile impuritiestest.(12)Amyl alcohol and nonvolatile, carbonizable substances This test is replaced with aVolatile impuritiestest.(13)Ultraviolet absorbance This test is added to comply with EPstandards.(14)Limit of acetone and isopropyl alcohol This test is replacedwith aVolatile impuritiestest.(15)Methanol This test is replaced with aVolatile impuritiestest.(16)Volatile impurities This chromatographic test is added tolimit a wide array of volatile impurities within a single testmethod.

5 (EMC: J. Lane) RTS 40773-1 Change to alcohol[64-17-5]. Alcohol contains not less than percent and notmore than percent, by weight, corresponding tonot less than percent and not more than per-cent, by volume, at , and storage Preserve in tight containers, remotefrom A:Mix 5 drops in a small beaker with 1 mL of potassium per-manganate solution (1 in 100) and 5 drops of 2 N sulfuric acid, andcover the beaker immediately with a filter paper moistened with asolution recently prepared by dissolving g of sodium nitrofer-ricyanide and g of piperazine in 5 mL of water.

6 An intense bluecolor is produced on the filter paper, the color becoming paler aftera few :To 5 mL of a solution (1 in 10) add 1 mL of N sodiumhydroxide, then slowly (over a period of 3 minutes) add 2 mL N iodine: the odor of iodoform develops, and a yellow preci-pitate is formed within 30 gravityh841i: between and at , indi-cating between and , by weight, or between , by volume, of To 50 mL, in a glass-stoppered flask, add 50 mL of re-cently boiled water. Add phenolphthalein TS, and titrate with sodium hydroxide to a pink color that persists for 30 seconds:not more than mL of N sodium hydroxide is requiredfor of nonvolatile residue Evaporate 40 mL in a tared dish ona water bath, and dry at 1058for 1 hour: the weight of the residuedoes not exceed 1 substances Dilute it with an equal volume ofwater.

7 The mixture is clear and remains clear for 30 minutes aftercooling to and other foreign organic substances Place 20 mLin a glass-stoppered cylinder that has been thoroughly cleaned withhydrochloric acid, then rinsed with water and finally with the Al-Pharmacopeial ForumVol. 30(2) [Mar. Apr. 2004]HARMONIZATION669#2004 The United States Pharmacopeial Convention, Rights to be tested. Cool the contents to approximately 158,andadd, by means of a carefully cleaned pipet, mL of N po-tassium permanganate, noting accurately the time of addition.

8 Mixat once by inverting the stoppered cylinder, and allow it to stand at158for 5 minutes: the pink color does not entirely alcohol and nonvolatile, carbonizable substances Allow25 mL to evaporate spontaneously from a porcelain dish, carefullyprotected from dust, until the surface of the dish is barely moist: nored or brown color is produced immediately upon the addition of afew drops of sulfuric of acetone and isopropyl alcohol To mL add mLof water, mL of a saturated solution of dibasic sodium phos-phate, and mL of a saturated solution of potassium permanga-nate.

9 Warm the mixture to 458to 508, and allow to stand until thepermanganate color is discharged. Add mL of N sodiumhydroxide, and filter, without washing, through a sintered-glass fil-ter. Prepare a control by mixing mL of the saturated solution ofdibasic sodium phosphate, mL of N sodium hydroxide, 80mg of acetone, and mL of water. To each solution add 1 mL offurfural solution (1 in 100), allow to stand for 10 minutes, then mL of each solution add 3 mL of hydrochloric acid: any pinkcolor produced in the test solution is not more intense than that inthe To 1 drop add 1 drop of water, 1 drop of dilute phos-phoric acid (1 in 20), and 1 drop of potassium permanganate solu-tion (1 in 20).

10 Mix, allow to stand for 1 minute, and add sodiummetabisulfite solution (1 in 20), dropwise, until the permanganatecolor is discharged. If a brown color remains, add 1 drop of thedilute phosphoric acid. To the colorless solution add 5 mL offreshly prepared chromotropic acid TS, and heat on a water bathat 608for 10 minutes: any violet color should not exceed that pro-duced by mg of methanol in 1 mL of water, treated in the sameway as the sample.~ alcohol[64-17-5]. Alcohol contains not less than percent andnot more than percent, by weight, corre-sponding to not less than percent and notmore than percent, by volume, at , and storage Preserve in tight containers, pro-tected from light.


Related search queries