品名(name)

马来酸噻吗洛尔（Timolol Maleate）

报告编号( Analytical Report No.)

20220316

批号（Batch No.）

20220316

化验单号（Analytical Report No.)

20220316

数量（Batch Quantity）

100kg

送检日期（Date Of Sampling）

2022/03/16

规格(Specification)

1kg

报告日期(Date Of Reporting)

2022/03/18

依据(According As)

USP34

有 效 期(Date Of Expiry)

2024/03/16

检验项目（Text ltems）

标准规定(Specification)

检验结果(Result)

性状(Description)

White to practically white, odorless or practically Odorless ,Power

Practically White crystalline                                       Power

鉴别

(Identfication)

Shall comply with USP34 tests,A and B

Complies

旋光度

(Specific rotation)  

Between  -11.7º and -12.5º

-11.8 º

炽灼残渣

(Residue on ignition) 

Not more than 0.1%

0.07%

重金属                            

（Heavy Metal）

Not more than 0.002%

<0.002%

干燥失重

(Loss on drying)

Not more than 0.5%

0.04%

pH(20mg/ml)

Between 3.8 and 4.3

4.1

色谱纯度（Chromatographic purity) 

No secondary spot is more intense than 0.4% and

     the sum of the intensities of the secondary spots,excluding any having intensities less than 0.1%,

does not exceed 1.0%  

CComplies

含量测定

（Assay）

 Not less than 98.0% and not more than 101.0%

99.6%

结论(Conclusion)

符合规定

In conformity with USP34