项 目
Item |
标准规定
Specification |
检验结果
Results |
性状
Appearance |
白色或类白色粉末
White or off white powder |
类白色粉末
Off-white powder |
鉴别
Identification |
红外光吸收图谱应与对照品的图谱一致
IR spectrum of sample corresponds to that of reference standard |
Conform |
|
HPLC测定中主峰保留时间与对照品的一致
The retention time of major peak in the chromatogram of the Assay preparation corrsponds to that in the chromatogram of the Standard preparation ,as obtained in the Assay |
Conform |
重金属
Heavy metal |
不得过百万之二十
Not more than 20ppm |
符合
Conform |
水分
Moisture |
不得过1.3%
Not more than 1.3% |
0.5%
|
灰分
Sulphated Ash |
不得过0.2%
Not more than 0.2% |
0.0% |
单一最大杂质
Single max impurity |
不得过2.5%
Not more than 2.5% |
1.0% |
总杂质
Total impurity |
不得过7.0%
Not more than7.0% |
2.9% |
含量
Assay（HPLC） |
按干燥品计算，含莫西菌素应为92.0～102.0%
Moxidectin contains not less than 92.0 per cent and not more than the equivalent of 102.0 per cent(Anhydrous substance) |
97.4% |
结论
Conclusion |
该批产品按企业标准检验，符合规定；
This batch product complies to in-house specification for Moxidectin. |
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