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2023 Pharma QC_隨堂測驗

Authored by 台灣默克股份有限公司MERCK Taiwan

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Professional Development

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2023 Pharma QC_隨堂測驗
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9 questions

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1.

MULTIPLE CHOICE QUESTION

10 sec • 1 pt

今天的會議地點在

台北

台中

台南

高雄

2.

MULTIPLE CHOICE QUESTION

20 sec • 5 pts

一般而言,分析impurities的偵測極限何者最低?

Drug substance

Drug product

Residual solvent

Highly toxic impurities

3.

MULTIPLE CHOICE QUESTION

20 sec • 5 pts

以下何者"並非"USP中分析nitrosamine的方法?

LC-MS/MS

IC-MS/MS

GC-MS/MS

4.

MULTIPLE CHOICE QUESTION

20 sec • 5 pts

藥典中方法哪個部分無法調整?

管柱粒徑

管柱長度內徑尺寸

偵測器波長

梯度program

管柱溫度

5.

MULTIPLE CHOICE QUESTION

20 sec • 5 pts

以下哪項"不是"使用Titripac的優點?

環保,減少廢棄物

避免滴定液被CO2汙染

開啟後,在效期內濃度不變

無須連接滴定儀

6.

MULTIPLE CHOICE QUESTION

20 sec • 5 pts

關於Merck藥物二級標準品,以下何者為是?

追溯到藥典標準品,並隨藥典標準品批號更新而更新

可以完全取代In House Working Standard

符合ISO17034 & ISO17025

以上皆是

7.

MULTIPLE CHOICE QUESTION

20 sec • 5 pts

關於Merck藥物二級標準品的CoA,以下何者為是?

依據ISO Guide 31準則撰寫

文件隨藥典標準品批號更新而更新,User可以隨時上網下載

提共Certified value並考慮量測不確定性

以上皆是

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