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标题: 产品BP最新标准 [打印本页]

作者: 一花一世界 时间: 2017-5-5 03:05 PM
标题: 产品BP最新标准
求助hydrotalcite 和hydrotalcite tablet 的BP最新标准以及rizatriptan benzoate的BP质量标准

作者: yanhong621 时间: 2017-5-25 10:53 AM
附件均是BP2017的

作者: yf09 时间: 2017-5-31 11:30 AM

General Notices
Action and use
Antacid.
DEFINITION
Hydrotalcite Tablets contain Hydrotalcite.
The tablets comply with the requirements stated under Tablets and with the following requirements.
Content of hydrotalcite, Al2Mg6(OH)16CO3,4H2O

90.0 to 110.0% of the stated amount.
IDENTIFICATION
Add 20 mL of 2M hydrochloric acid to a quantity of the powdered tablets containing 1.0 g of Hydrotalcite, shake and filter. Add 30 mL of water to the filtrate
and boil. Add 2M ammonia until just alkaline to methyl red, continue boiling for 2 minutes and filter. Wash the precipitate with 50 mL of a hot 2% w/v
solution of ammonium chloride and dissolve in 15 mL of 2M hydrochloric acid. The resulting solution yields the reaction characteristic of aluminium salts,
Appendix VI.
Neutralising capacity
Weigh and powder 20 tablets, pass the powder as completely as possible through a sieve of nominal mesh aperture about 225 μm and remix the sifted
powder. Mix a quantity equivalent to one tablet with a small quantity of water, added slowly with stirring, to give a smooth paste and add gradually sufficient
further quantities of water to produce 100 mL. Warm to 37°, add 100 mL of 0.1M hydrochloric acid VS previously heated to 37° and stir continuously using
a paddle stirrer at a rate of about 200 revolutions per minute, maintaining the temperature at 37°. The pH of the solution at 37°, after 10 minutes and after
20 minutes, is 3.0 to 4.2, Appendix V L. Add 12 mL of 0.5M hydrochloric acid VS at 37°, stir continuously for 1 hour, maintaining the temperature at 37°,
and titrate with 0.1M sodium hydroxide VS to pH 3.5. Subtract the number of mL of 0.1M sodium hydroxide VS from 160 mL to obtain the number of mL of
0.1M hydrochloric acid VS required for neutralisation. Not less than 130 mL of 0.1M hydrochloric acid VS is required to neutralise one tablet.
ASSAY
Weigh and powder 20 tablets. To a quantity of the powder containing 0.3 g of Hydrotalcite add 2 mL of 7M hydrochloric acid and heat on a water bath for
15 minutes. Allow to cool, add 250 mL of water and 50 mL of 0.05M disodium edetate VS and neutralise with 1M sodium hydroxide using methyl red
solution as indicator. Heat the solution on a water bath for 30 minutes and allow to cool. Add 3 g of hexamine and titrate the excess of disodium edetate
with 0.05M lead nitrate VS using xylenol orange solution as indicator. Each mL of 0.05M disodium edetate VS is equivalent to 15.09 mg of Al
2Mg6(OH)
16CO3,4H2O.
Status: Version effective from 01/01/2017.
Hydrotalcite Tablets
© Crown Copyright 2016
Hydrotalcite Tablets
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