代查USP39 EP9.0 BP2016-2017 JP16英文 JP17日文每人仅限一个标准，更多请站内咨询

liuqygood2005 · 发表于 2016-10-28 10:05:07

有没有药品包装用铝箔 Aluminum Foil的标准，麻烦查下，多谢！

adliu611 · 发表于 2016-10-28 10:17:26

版主真是牛！

qevilcrystal · 发表于 2016-10-28 10:21:50

大大好，能再麻烦代查一下usp39的盐酸二甲双胍（Metformin）及其制剂吗？谢谢了

jiubugaosuni · 发表于 2016-10-28 11:09:49

言石发表于 2016-10-26 10:38
楼主好，麻烦查下 USP1231 谢谢

-1231- WATER FOR PHARMACEUTICAL PURPOSES.pdf (1.77 MB, 下载次数: 67)

jiubugaosuni · 发表于 2016-10-28 11:12:33

qevilcrystal 发表于 2016-10-28 10:21
大大好，能再麻烦代查一下usp39的盐酸二甲双胍（Metformin）及其制剂吗？谢谢了

Metformin Hydrochloride Tablets USP39.pdf (95.49 KB, 下载次数: 5)

jiubugaosuni · 发表于 2016-10-28 11:13:06

liuqygood2005 发表于 2016-10-28 10:05
有没有药品包装用铝箔 Aluminum Foil的标准，麻烦查下，多谢！

好像是没有

泡泡的忧伤 · 发表于 2016-10-28 11:32:10

楼主好，请帮忙查一下乳酸钠溶液（Sodium Lactate Solution）USP39，EP9.0，BP2016，谢谢了

ANNAZNJ · 发表于 2016-10-28 14:10:15

楼主好，麻烦查下EP9 .Ribavirin.

liuqygood2005 · 发表于 2016-10-28 14:38:37

jiubugaosuni 发表于 2016-10-28 11:13
好像是没有

谢谢了！

jiubugaosuni · 发表于 2016-10-29 20:52:00

泡泡的忧伤发表于 2016-10-28 11:32
楼主好，请帮忙查一下乳酸钠溶液（Sodium Lactate Solution）USP39，EP9.0，BP2016，谢谢了

Sodium lactate solution EP9.0.pdf (101.35 KB, 下载次数: 4)

2016-10-29 20:51 上传

点击文件名下载附件

Sodium Lactate Solution USP39.pdf (92.64 KB, 下载次数: 4)

2016-10-29 20:51 上传

点击文件名下载附件
BP2016
Sodium Lactate Solution

General Notices

(Ph. Eur. monograph 1151)
Action and useSystemic alkalinising agent.

Ph Eur

DEFINITIONSolution of a mixture of the enantiomers of sodium 2-hydroxypropanoate in approximately equal proportions.
ContentMinimum declared content 50 per cent m/m of sodium 2-hydroxypropanoate (C3H5NaO3; 112.1); 96.0 per cent to 104.0 per cent of the content of sodium lactate stated on the label.
CHARACTERSAppearanceClear, colourless, slightly syrupy liquid.
SolubilityMiscible with water and with ethanol (96 per cent).
IDENTIFICATIONA. To 0.1 mL add 10 mL of water R. 5 mL of the solution gives the reaction of lactates (2.3.1).
B. It gives reaction (a) of sodium (2.3.1).
TESTSSolution SDilute a quantity of the substance to be examined corresponding to 40.0 g of sodium lactate to 200 mL with distilled water R.
Appearance of solutionThe substance to be examined is clear (2.2.1) and not more intensely coloured than reference solution BY7 (2.2.2, Method II).
pH (2.2.3)6.5 to 9.0 for the substance to be examined.
Reducing sugars and sucroseTo 5 mL of the substance to be examined add 0.2 mL of copper sulfate solution R and 2 mL ofdilute sodium hydroxide solution R. The solution is clear and blue and remains so on boiling. Add to the hot solution 4 mL of hydrochloric acid R. Boil for 1 min. Add 6 mL of strong sodium hydroxide solution R and heat to boiling again. The solution is clear and blue.
MethanolGas chromatography (2.4.24).
Limit:
— methanol: maximum 50 ppm, calculated with reference to sodium lactate, if intended for use in the manufacture of parenteral preparations, dialysis, haemodialysis or haemofiltration solutions.
Chlorides (2.4.4)Maximum 50 ppm calculated with reference to sodium lactate.
Dilute 5 mL of solution S to 15 mL with water R. The solution complies with the test for chlorides.
Oxalates and phosphatesTo 1 mL of the substance to be examined add 15 mL of ethanol (96 per cent) R and 2 mL of calcium chloride solution R. Heat at 75 °C for 5 min. Any opalescence in the solution is not more intense than that of a standard prepared at the same time and in the same manner using a mixture of 1 mL of the substance to be examined, 15 mL of ethanol (96 per cent) R and 2 mL of water R.
Sulfates (2.4.13)Maximum 100 ppm calculated with reference to sodium lactate.
To 7.5 mL of solution S, add 1.9 mL of hydrochloric acid R1 and dilute to 15 mL with distilled water R. The solution complies with the test for sulfates without addition of 0.5 mL of acetic acid R. Acidify the standard solution with 0.05 mL of hydrochloric acid R1 instead of 0.5 mL ofacetic acid R.
AluminiumMaximum 0.1 ppm, if intended for use in the manufacture of parenteral preparations, dialysis, haemodialysis or haemofiltration solutions.
Atomic absorption spectrometry (2.2.23, Method I). For the preparation of the solutions, use equipment that is aluminium-free or that will not release aluminium under the conditions of use (glass, polyethylene, etc).
Modifier solution Dissolve 100.0 g of ammonium nitrate R in a mixture of 4 mL of nitric acid Rand 50 mL of water R and dilute to 200 mL with water R.
Blank solution Dilute to 2.0 mL of the modifier solution to 25.0 mL with water R.
Test solution To 5.0 g add 2.0 mL of the modifier solution and dilute to 25.0 mL with water R.
Reference solutions Prepare the reference solutions immediately before use (0.010 ppm to 0.050 ppm of aluminium) using aluminium standard solution (200 ppm Al) R.
Source Aluminium hollow-cathode lamp.
Wavelength 309.3 nm.
Atomisation device A graphite furnace.
Carrier gas argon R.
Conditions The device is equipped with a non-specific absorption correction system. Heat the oven to 120 °C for as many seconds as there are microlitres of solution introduced into the apparatus, then heat at 1000 °C for 30 s and finally at 2700 °C for 6 s.
BariumTo 10 mL of solution S add 10 mL of calcium sulfate solution R. Allow to stand for 30 min. Any opalescence (2.2.1) in the solution is not more intense than that of a standard prepared at the same time and in the same manner using a mixture of 10 mL of solution S and 10 mL of distilled water R.
Iron (2.4.9)Maximum 10 ppm calculated with reference to sodium lactate.
Dilute 5 mL of solution S to 10 mL with water R. The solution complies with the test for iron.
Heavy metals (2.4.8)Maximum 10 ppm calculated with reference to sodium lactate.
12 mL of solution S complies with test A. Prepare the reference solution using lead standard solution (2 ppm Pb) R.
Bacterial endotoxins (2.6.14)Less than 5 IU/g, if intended for use in the manufacture of parenteral preparations without a further appropriate procedure for the removal of bacterial endotoxins.
ASSAYDissolve a quantity of the substance to be examined corresponding to 75.0 mg of sodium lactate in a mixture of 10 mL of glacial acetic acid R and 20 mL of acetic anhydride R. Allow to stand for 15 min. Add 1 mL of naphtholbenzein solution R and titrate with 0.1 M perchloric acid.
1 mL of 0.1 M perchloric acid is equivalent to 11.21 mg of C3H5NaO3.
LABELLINGThe label states:
— where applicable, that the substance is suitable for use in the manufacture of dialysis, haemodialysis and haemofiltration solutions,
— where applicable, that the substance is suitable for use in the manufacture of parenteral preparations,
— the declared content of sodium lactate.

Ph Eur

jiubugaosuni · 发表于 2016-10-29 20:52:37

ANNAZNJ 发表于 2016-10-28 14:10
楼主好，麻烦查下EP9 .Ribavirin.

Ribavirin Ep9.0.pdf (139.57 KB, 下载次数: 7)

freeer06 · 发表于 2016-10-30 12:40:54

能麻烦楼主办我查一下USP39 <1223>Validation of Alternative Microbiological Methods和<1227>Validation of Microbial Recovery，非常感谢。

jiubugaosuni · 发表于 2016-10-30 20:12:44

freeer06 发表于 2016-10-30 12:40
能麻烦楼主办我查一下USP39 Validation of Alternative Microbiological Methods和Validation of Microbial ...

-1223- VALIDATION OF ALTERNATIVE MICROBIOLOGICAL METHODS.pdf (556.63 KB, 下载次数: 49)

hongyu · 发表于 2016-10-30 20:53:54

谢谢楼主

freeer06 · 发表于 2016-10-30 22:43:04

jiubugaosuni 发表于 2016-10-30 20:12

多谢楼主了

陌上疏_羚 · 发表于 2016-11-1 14:57:23

麻烦帮忙查一下 Tacrolimus（他克莫司）的USP39（第一增补版和第二增补版），谢谢~~

yuannju · 发表于 2016-11-14 22:18:47

你好，麻烦帮忙查询一下
Trihexyphenidyl Hydrochloride Tablets（盐酸苯海索片）USP40-NF35和Trihexyphenidyl Hydrochloride（盐酸苯海索） EP9.0，十分感谢！

amber30 · 发表于 2016-11-15 14:46:45

你好，麻烦你帮忙查询下USP39的苯磺顺阿曲库铵注射液（Cisatracurium Besylate Injection）和苯磺顺阿曲库铵（Cisatracurium Besylate）的标准，谢谢！

焱木V · 发表于 2016-11-15 15:56:21

楼主您好，麻烦帮忙查一下USP39第一增补版的Dronedarone hydrochloride的标准，十分感谢

jiubugaosuni · 发表于 2016-11-15 19:04:09

陌上疏_羚发表于 2016-11-1 14:57
麻烦帮忙查一下 Tacrolimus（他克莫司）的USP39（第一增补版和第二增补版），谢谢~~

Tacrolimus USP39 S1.pdf (159.03 KB, 下载次数: 2)

[药典/标准文件] 代查USP39 EP9.0 BP2016-2017 JP16英文 JP17日文每人仅限一个标准，更多请站内咨询

点评

浏览过的版块

[药典/标准文件] 代查USP39 EP9.0 BP2016-2017 JP16英文 JP17日文 每人仅限一个标准，更多请站内咨询

点评

浏览过的版块

[药典/标准文件] 代查USP39 EP9.0 BP2016-2017 JP16英文 JP17日文每人仅限一个标准，更多请站内咨询