样品名称

Product Name

利福布丁

Rifabutin

批号

Batch No

201405001

代表量

LotQuantity

50Kg

生产日期

MFG. Date

May 09,2014

包装规格

Pachingy

5Kgper tin

（5Kg/听）

失效期

EXP.Date

May 08^,2018

引用标准

Standard

USP33

检验项目Items of Analysis    标准规定（Standard）    检验结果（Results of analysis）

1、Indentification

(A) Infra-red absorption  (A) Concordant with reference Spectrum    (A) Identical with Reference Spectrum.

(B) HPLC    (B)Retention time of major peak in    (B) Meet the test.

Assay  preparation corresponds to

that of the standard preparation.    

2、water    NMT 2.5%    1.1%

3、Limit of N-Iso    NMT 0.5%    0.21%

Butylpiperidone

4、Chromatopraphic Purity

(A)Each individual impurity at    (A) NMT 1%     (A) 0.03%, 0.02%

about RRT 0.5,0.6,0.8 and    0.05%, 0.42%

  1.4 with respect to Rifabutin

(B)Each other individual impurity    (B) NMT 0.5%    (B) Meet the Test

(0.25%)

(C)Total Impurity(C)    NMT 3.0%    (C) 2.2%

5、Assay (C46H62N4O11)

On anhydrous basis    95.0% to 102.0%    97.3%

结论（Result）

符合规定（They’dproduct conforms to the USP33）

备注（Remark）