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[求助] 求白消安usp36质量标准

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1楼 2013-05-05 13:10:08

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kobeyy

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感谢参与，应助指数 +1
痴夷子皮: 金币+2, 谢谢提供。 2013-05-06 10:10:46

Busulfan
(bue sul' fan).

C6H14O6S2 246.30

1,4-Butanediol, dimethanesulfonate.
1,4-Butanediol dimethanesulfonate [55-98-1].
Busulfan contains not less than 98.0 percent and not more than 100.5 percent of C6H14O6S2, calculated on the dried basis.
Packaging and storage— Preserve in tight containers.
Labeling— The label bears a warning that great care should be taken to prevent inhaling particles of Busulfan and exposing the skin to it.
Identification—
A: Fuse about 100 mg with about 100 mg of potassium nitrate and a pellet of potassium hydroxide weighing approximately 250 mg. Cool, dissolve the residue in water, acidify with 3 N hydrochloric acid, and add a few drops of barium chloride TS: a white precipitate is formed.
B: To 100 mg add 10 mL of water and 5 mL of 1 N sodium hydroxide. Heat until a clear solution is obtained: an odor characteristic of methanesulfonic acid is perceptible.
C: Cool the solution obtained in Identification test B, and divide it into two equal portions. To one portion add 1 drop of potassium permanganate TS: the purple color changes to violet, then to blue, and finally to emerald-green. Acidify the second portion of the solution with 2 N sulfuric acid, and add 1 drop of potassium permanganate TS: the color of the permanganate is not discharged.
Melting range 741: between 115 and 118.
Loss on drying 731— Dry it in vacuum at 60 to constant weight: it loses not more than 2.0% of its weight.
Residue on ignition 281: not more than 0.1%.
Assay— Transfer about 80 mg of Busulfan, accurately weighed, to a 250-mL conical flask. Add about 30 mL of water, swirl, add phenolphthalein TS, and neutralize with 0.05 N sodium hydroxide. Connect the flask to a reflux air condenser, and boil the mixture gently for not less than 30 minutes, adding water occasionally to maintain the volume. Cool to room temperature, add phenolphthalein TS, and titrate with 0.05 N sodium hydroxide VS. Each mL of 0.05 N sodium hydroxide is equivalent to 6.158 mg of C6H14O6S2.
Auxiliary Information— Please check for your question in the FAQs before contacting USP.
Topic/Question Contact Expert Committee
Monograph  Feiwen Mao, M.S.
Senior Scientific Liaison
1-301-816-8320  (SM32010) Monographs - Small Molecules 3

USP36–NF31 Page 2713
Chromatographic Column—
BUSULFAN
Chromatographic columns text is not derived from, and not part of, USP 36 or NF 31.

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2楼2013-05-06 10:06:38

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Busulfan Tablets
Busulfan Tablets contain not less than 93.0 percent and not more than 107.0 percent of the labeled amount of C6H14O6S2.
Packaging and storage— Preserve in well-closed containers.
Identification— Pulverize a suitable number of Tablets, and extract the powder with several portions of acetone. Evaporate the combined acetone extracts, with the aid of a current of air, on a steam bath: the dry residue responds to the Identification tests under Busulfan, and melts at about 115.
Disintegration 701: 30 minutes, the use of disks being omitted.
Uniformity of dosage units 905: meet the requirements.
Assay— Weigh and finely powder not fewer than 40 Tablets. [Caution—Guard against accidental inhalation of fine powder. ] Weigh accurately a portion of the powder, equivalent to about 80 mg of busulfan, and transfer to a 100-mL beaker. Extract with four 20-mL portions of acetone, each time stirring the mixture well, then allowing the insoluble matter to settle, and finally decanting the supernatant through a sintered-glass filter into a 250-mL conical flask. Evaporate the combined acetone extracts to about 10 mL, add phenolphthalein TS, and neutralize with 0.05 N sodium hydroxide. Evaporate to dryness, add about 30 mL of water, and proceed as directed in the Assay under Busulfan, beginning with “Connect the flask.” Each mL of 0.05 N sodium hydroxide is equivalent to 6.158 mg of C6H14O6S2.
Auxiliary Information— Please check for your question in the FAQs before contacting USP.
Topic/Question Contact Expert Committee
Monograph  Feiwen Mao, M.S.
Senior Scientific Liaison
1-301-816-8320  (SM32010) Monographs - Small Molecules 3
701  Margareth R.C. Marques, Ph.D.
Senior Scientific Liaison
1-301-816-8106  (GCDF2010) General Chapters - Dosage Forms

USP36–NF31 Page 2713

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3楼2013-05-06 10:07:00

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