Capecitabine--NINGBO TAIKANG CHEMICAL CO.,LTD--1-(2,3-Dichlorophenyl)-piperazine hydrochloride| 1-(3-Chlorophenyl)piperazine hydrochloride| 1-Phenylpiperazine hydrochloride| FMT CAS NO. 82294-70-0| PHE CAS NO.115065-79-7

Product Category

API

Capecitabine

Cas No.:154361-50-9
Usage/STANDARD:

 

检验报告单
Certificate of Analysis
产品名称
Product Name
卡培他滨
Capecitabine
CAS No.
154361-50-9
Batch No.
120501
Quantity
200Kg
生产日期
Mfg. Date
2012.05.01
检验日期
Date of Analysis
2012.05.09
有效期至
Exp. Date
--
报告日期
Date of Release
2012.05.09
执行标准
Carried Standard
USP-34
Items
标准规定
Specification
Results
外观
Appearance
白色粉末
white powder
符合
Conforms
旋光度(20℃)
Optical rotation
+960~+1000
+98.10
水分
Water(K.F)
<0.3
0.23
炽灼残渣
Residue on ignition
<0.1
0.05
重金属
Heavy metals
<0.002%(20PPM)
<20PPM
色谱纯度(HPLC)
Chromatographic purity
单一杂质
Individual impurity    <0.1%
总杂质
Total impurities        <1.0%
 
0.098%
 
0.098%
含量(HPLC
Assay  HPLC
98.0%~102.0%
99.90%
Conclusion
Pass
Analyst:01                                                                     Checker: 02                              

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