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无水葡萄糖形成药典标准形成因素
来源:http://www.sspp8.com 日期:2019-05-27 发布人:admin
本品为无色结晶或白色结晶性或颗粒性粉末;无臭,味甜。
This product is colorless crystalline or white crystalline or granular powder; odorless and sweet.
本品在水中易溶,在乙醇中微溶。
This product is soluble in water and slightly soluble in ethanol.
比旋度
Specific rotation
取本品约10g,精细称定,置50ml量瓶中,加水适量与氨试液2.0ml溶解后,用水稀释至刻度,摇匀,放置60分钟,在25℃时依法测定(2010年版药典二部附录Ⅵ E),比旋度为+52.6°至+53.2°。
Take this product about 10g, weigh it carefully, put it in a 50ml measuring bottle, add water and dissolve 2.0ml ammonia test solution, dilute it with water, shake it well and put it for 60 minutes. Measure it at 25 C according to law (Appendix VI E of 2010 Pharmacopoeia II). The specific curl is +52.6 to +53.2.
鉴别
Identify
(1)取本品约0.2g,加水5ml溶解后,缓缓滴入微温的碱性酒石酸铜试液中,即生成氧化亚铜的红色沉淀。
(1) The product is about 0.2g, dissolved with water for 5ml, and then slowly dripped into the slightly warm alkaline copper tartrate test solution to form the red precipitation of cuprous oxide.
(2)本品的红外光吸收图谱应与对照的图谱(《药品红外光谱集》702图)分歧。
(2) The infrared absorption spectra of the product should be different from those of the control (702 in the Infrared Spectra of Drugs).
检查
inspect
酸度
acidity
取本品2.0g,加水20ml溶解后,加酚酞指示液3滴与氢氧化钠滴定液(0.02mol/L)0.20ml,应显粉红色。
After 2.0g of this product is dissolved with 20 ml of water, 3 drops of phenolphthalein indicator solution and 0.20ml of sodium hydroxide titration solution (0.02mol/L) should be pink.
溶液的廓清度与颜色
Clearance and colour of solution
取本品5.0g,加热水溶解后,放冷,用水稀释至10ml,溶液应廓清无色;如显混浊,与1号浊度规范液(2010年版药典二部附录Ⅸ B)比拟,不得更浓;如显色,与对照液(取比色用氯化钴液3.0ml、比色用重铬酸钾液3.0ml与比色用硫酸铜液6.0ml,用水稀释成50ml)1.0ml用水稀释至10ml比拟,不得更深。
无水葡萄糖
Take 5.0g of this product, dissolve it in hot water, cool it, dilute it with water to 10ml, the solution should be clear and colorless; if turbidity appears, it should not be more concentrated than turbidity standard solution No. 1 (Appendix IX B of Pharmacopoeia No. 2, 2010 edition); if colour develops, it should be diluted with water 1.0ml compared with control solution (cobalt chloride solution 3.0ml for colour comparison, potassium dichromate solution 3.0ml for colour comparison, copper sulfate solution 6.0mL for colour comparison and water dilution to 50ml for colour comparison). Release to 10 ml, not deeper.
乙醇溶液的廓清度
Clearance of Ethanol Solution
取本品1.0g,加乙醇20ml,置水浴上加热回流约40分钟,溶液应廓清。
Take 1.0g of this product, add 20ml ethanol, put it in a water bath, heat and reflux for about 40 minutes, the solution should be clear.
氯化物
chloride
取本品0.60g,依法检查(2010年版药典二部附录Ⅷ A),与规范氯化钠溶液6.0ml制成的对照液比拟,不得更浓(0.01%)。
Take 0.60g of this product and inspect it according to law (Appendix_A of the second part of Pharmacopoeia 2010 edition). Compared with the control solution of 6.0mL sodium chloride solution, it should not be more concentrated (0.01%).
硫酸盐
sulfate
取本品2.0g,依法检查(2010年版药典二部附录Ⅷ B),与规范硫酸钾溶液2.0ml制成的对照液比拟,不得更浓(0.01%)。
Take 2.0g of this product and inspect it according to law (Appendix_B of the second part of Pharmacopoeia 2010 edition). Compared with the control solution of 2.0ml standard potassium sulfate solution, it should not be more concentrated (0.01%).
亚硫酸盐与可溶性淀粉
Sulfite and soluble starch
取本品1.0g,加水10ml溶解后,加碘试液1滴,应即显黄色。
Take 1.0g of this product, add 10 ml of water to dissolve, add 1 drop of iodine test solution, it should be yellow.
枯燥失重
Dull and weightlessness
取本品,在105℃枯燥至恒重,减失重量不得过1.0%(2010年版药典二部附录Ⅷ L)。
Take this product, dry to constant weight at 105 (L, Appendix II, 2010 edition of Pharmacopoeia) and lose no more than 1.0% (weight).
炽灼残渣
Scorching residue
不得过0.1%(2010年版药典二部附录Ⅷ N)。
No more than 0.1% (Appendix_N of the 2010 edition of the Pharmacopoeia).
蛋白质
Protein
取本品1.0g,加水10ml溶解后,加磺基水杨酸溶液(1→5)3ml,不得发作混浊或沉淀。
Take 1.0g of this product, add 10 ml of water to dissolve, add sulfosalicylic acid solution (1 5) 3 ml, no turbidity or precipitation.
钡盐
Barium salt
取本品2.0g,加水20ml溶解后,溶液分红两等份,一份中加稀硫酸1ml,另一份中水1ml,摇匀,放置15分钟,两液均应廓清。
Take 2.0g of this product, add 20 ml water to dissolve, the solution dividends into two equal parts, one with dilute sulfuric acid 1ml, the other with water 1ml, shake well, put for 15 minutes, both liquids should be cleared.
钙盐
Calcium salt
取本品1.0g,加水10ml溶解后,加氨试液1ml与草酸铵试液5ml,摇匀,放置1小时,如发作混浊,与规范钙溶液[精细称取碳酸钙0.1250g,置500ml量瓶中,加水5ml与盐酸0.5ml使溶解,用水稀释至刻度,摇匀。每1ml相当于0.1mg的钙(Ca)]1.0ml制成的对照液比拟,不得更浓(0.01%)。
Take 1.0 g of this product, add 10 ml of water to dissolve, add 1 ml of ammonia test solution and 5 ml of ammonium oxalate test solution, shake well, place for 1 hour, such as turbidity, and standard calcium solution [fine weigh calcium carbonate 0.1250 g, put 500 ml measuring bottle, add 5 ml of water and 0.5 ml of hydrochloric acid to dissolve, dilute water to scale, shake well. The control solution made of 1.0 ml of calcium (Ca) equivalent to 0.1 mg per ml should not be more concentrated (0.01%).
铁盐
Ferric salt
取本品2.0g,加水20ml溶解后,加硝酸3滴,迟缓煮沸5分钟,放冷,用水稀释制成45ml,加硫氰酸铵溶液(30→100)3.0ml,摇匀,如显色,与规范铁溶液2.0ml用同一办法制成的对照液比拟,不得更深(0.001%)。
Take 2.0g of this product, add 20 ml of water to dissolve, add 3 drops of nitric acid, slow boil for 5 minutes, cool down, dilute with water to make 45 ml, add ammonium thiocyanate solution (30 100) 3.0ml, shake well, such as color rendering, compared with the reference solution of 2.0ml of standard iron solution, no deeper (0.001%).
重金属
heavy metal
取本品5.0g,加水23ml溶解后,加醋酸盐缓冲液(pH 3.5)2ml,依法检查(2010年版药典二部附录Ⅷ H第一法),含重金属不得过百万分之四。
Take 5.0g of this product, add water 23ml to dissolve, add acetate buffer (pH 3.5) 2ml, and inspect according to law (Appendix_H first method of 2010 edition of Pharmacopoeia II), containing no more than four parts per million of heavy metals.
砷盐
Arsenic salt
取本品2.0g,加水5ml溶解后,加稀硫酸5ml与溴化钾溴试液0.5ml,置水浴上加热约20分钟,使坚持稍过量的溴存在,必要时,再补加溴化钾溴试液适量,并随时补充蒸散的水分,放冷,加盐酸5ml与水适量使成28ml,依法检查(2010年版药典二部附录Ⅷ J第一法),应契合规则(0.0001%)。
Take 2.0g of this product and dissolve it with 5 ml of water, add 5 ml of dilute sulfuric acid and 0.5 ml of potassium bromide test solution, heat it in water bath for about 20 minutes, so as to persist in the existence of slightly excessive bromide. If necessary, add appropriate amount of potassium bromide test solution, and at any time add evaporated water, cool it, add 5 ml of hydrochloric acid and water to make it 28 ml, and check it according to law (Appendix J1of 2010 edition of Pharmacopoeia II). (0.0001%).
微生物限度
microbial limit
取本品10g,用pH 7.0无菌氯化钠-蛋白胨缓冲液制成1: 10的供试液。
10 g of this product was used to prepare 1:10 test solution with pH 7.0 sterile Sodium Chloride Peptone buffer.
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