Levetiracetam Levetiracetam Levetiracetam
1. GMP AVALIABLE ;
2. IN STOCK
3. FAST REPLY
QUALIFED ; EFFICIENCY; RESPONSIBLE
检验项目TEST ITEMS |
标准规定SPECIFICATIONS |
检验结果RESULTS |
外观 Appearance |
白色或类白色粉末 A white or almost white powder |
白色粉末 A white powder |
鉴别 Identification |
1) I R:供试品红外光谱图应与标准品一致 IR:the infrared Absorption of the test 2) RRT:在含量测试项下供试品主峰保留时间应与标准品一致 The retention time of sample corresponds to the standard |
Complies |
水分water |
≤0.5% |
<0.1% |
硫酸盐灰份Sulphated ash |
≤0.1% |
<0.1% |
重金属Heavy metals |
≤20ppm |
<20ppm |
异构体(杂质D)Isomer(Impurity D) |
≤0.50% |
ND |
杂质B Impurity B |
≤0.10% |
0.03% |
有关物质 Related substances |
|
|
杂质A ImpurityA 左乙拉西坦酸Levetiracetam acid 其它单个杂质Any other individual impurity 总杂质Total impurities |
≤0.05% ≤0.10% ≤0.05% ≤0.40% |
ND 0.05% ND 0.05% |
含量 Assay |
98.0%~102.0% |
99.0% |
结 论 CONCLUSION |
本品按美国药典检验,结果符合规定 It complies with all the requirements of USP33 |
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