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樣品名稱

Product Name

利福噴丁

Rifapentine

批號

Batch No

20140112

代表量

LotQuantity

500Kg

取樣日期

Submitted Date

2014.01.15

包裝規(guī)格

Pachingy

25Kgper drum

（25Kg/桶）

失效期

EXP.date

2016.01.09

引用標準

Standard

In-house standard

檢驗項目Items of Analysis       標準規(guī)定（Standard）       檢驗結(jié)果（Results of analysis）

CHARACTERS      Dark red crystal powder        Conform

INDENTIFICATION

(A)By UV:On examining between 400nm to 500nm,

The test solution should show the absorbance maxima at about 478nm

(B)By IR:The IR spectrum of substance should      Conform

Concordant to that of working standard.

SOLUBILITY       It is freely soluble in chloroform and in

Methanol,slightly soluble in ethanol,acetone and n-butyl alcohol,       Conform

Almost insoluble in ether,water,benzene and methyl benzene

ACIDITY PH      4.0-8.0      6.1

LOSS ON DRYING       MAX.8.0%       5.5%

RESIDUE ON IGNITION       MAX0.2%      0.05%

REMAINED SOLVEN        

THE AMOUNT OF ETHANOL   1.0-3.5%       1.2%

      NMT1.0%&      0.33%

RELATED SUBSTANCE     

Any individual impurity        Conform

Total imputiry      NMT 3.0%       2.1%

HEAVY METAL      NMT 20PPM       Conform

ASSAY（on dry basis）       NLT 97.0%       98.3%

結(jié)論（Result）

符合規(guī)定（They’dproduct conforms to theIn-house standard）

備注（Remark）