品名(name)

馬來(lái)酸噻嗎洛爾（Timolol Maleate）

報(bào)告編號(hào)( Analytical Report No.)

20220316

批號(hào)（Batch No.）

20220316

化驗(yàn)單號(hào)（Analytical Report No.)

20220316

數(shù)量（Batch Quantity）

100kg

送檢日期（Date Of Sampling）

2022/03/16

規(guī)格(Specification)

1kg

報(bào)告日期(Date Of Reporting)

2022/03/18

依據(jù)(According As)

USP34

有 效 期(Date Of Expiry)

2024/03/16

檢驗(yàn)項(xiàng)目（Text ltems）

標(biāo)準(zhǔn)規(guī)定(Specification)

檢驗(yàn)結(jié)果(Result)

性狀(Description)

White to practically white, odorless or practically Odorless ,Power

Practically White crystalline                                       Power

鑒別

(Identfication)

Shall comply with USP34 tests,A and B

Complies

旋光度

(Specific rotation)  

Between  -11.7º and -12.5º

-11.8 º

熾灼殘?jiān)?/strong>

Not more than 0.1%

0.07%

重金屬                            

（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

色譜純度（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

含量測(cè)定

（Assay）

 Not less than 98.0% and not more than 101.0%

99.6%

結(jié)論(Conclusion)

符合規(guī)定

In conformity with USP34