Study on Sterility Test of Non-aqueous Clonazepam Injection

Lu WANG; Dong XIANG; Yan ZHANG; Qin LIU; Shan HUANG; Fan XU

doi:10.12259/j.issn.2095-610X.S20231112

Volume 44 Issue 11

Nov. 2023

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Article Navigation > Journal of Kunming Medical University > 2023 > 44(11): 82-86

Lu WANG, Dong XIANG, Yan ZHANG, Qin LIU, Shan HUANG, Fan XU. Study on Sterility Test of Non-aqueous Clonazepam Injection[J]. Journal of Kunming Medical University, 2023, 44(11): 82-86. doi: 10.12259/j.issn.2095-610X.S20231112

Citation:

Lu WANG, Dong XIANG, Yan ZHANG, Qin LIU, Shan HUANG, Fan XU. Study on Sterility Test of Non-aqueous Clonazepam Injection[J]. Journal of Kunming Medical University, 2023, 44(11): 82-86. doi: 10.12259/j.issn.2095-610X.S20231112

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Study on Sterility Test of Non-aqueous Clonazepam Injection

doi: 10.12259/j.issn.2095-610X.S20231112

Lu WANG¹,
Dong XIANG¹,
Yan ZHANG¹,
Qin LIU¹,
Shan HUANG²,
Fan XU^{3
,
,}

1.
Yunnan Institute For Food and Drug Control，Ministry of Industry and Information Technology Industrial Technology Basic Public Service Platform，Yunnan Kunming 650106
2.
Zhejiang TAILIN Bioengineering Co.，LTD ，Zhejiang Hangzhou 310051
3.
920 Hospital of Joint Logistic Support Force，Yunnan Kunming 650032，China

Received Date: 2023-09-01
Available Online: 2023-11-11
Publish Date: 2023-11-30

Abstract

Abstract

Objective To establish a method for sterility test of non-aqueous clonazepam injection, and explore the effect of organic solvent on sterility test. Methods With reference to the 2020 edition of Chinese Pharmacopoeia, the effects of organic solvents in Clonazepam injection on the filtration membranes and cups of different materials of the collector were investigated by membrane filtration test and membrane permeability test, as well as the effects of pH value of the sample solution and the variety and quantity of the rinsed solution on the microorganisms in the sample. Results Benzyl alcohol, acetic acid and anhydrous ethanol caused the dissolution of composite cellulose membrane, nylon membrane and PVDF membrane in different degrees, and the dissolution of composite cellulose membrane was more serious, and the benzyl alcohol remaining in the cup and filter membrane was insoluble in the medium and caused turbidity. The reaction of propylene glycol with AS cup made the medium cloudy. The pH range of the culture-medium was 5.99 ~ 7.16 after washing with different rinsing solutions. Conclusions We have developed a rational sterile testing method, which provides a good reference value for the sterile inspection of injections using organic phases as solvents.
- Clonazepam injection,
- Sterility test,
- Organic solvent,
- Collection incubator,
- Method optimization

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References(16)

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