Message Board

Respected readers, authors and reviewers, you can add comments to this page on any questions about the contribution, review,        editing and publication of this journal. We will give you an answer as soon as possible. Thank you for your support!

Name
E-mail
Phone
Title
Content
Verification Code
x Close Forever Close
Volume 22 Issue 2
. 
Turn off MathJax
Article Contents
Article Navigation >  Journal of Pharmaceutical Practice and Service  > 2004  >  (2): 88-91

CHEN Zhu-kang, PENG Xin-sheng, CHEN Gui-liang. Study on determination of particulate matter in small volume injections and sterile powder for injection[J]. Journal of Pharmaceutical Practice and Service, 2004, (2): 88-91.
Citation: CHEN Zhu-kang, PENG Xin-sheng, CHEN Gui-liang. Study on determination of particulate matter in small volume injections and sterile powder for injection[J]. Journal of Pharmaceutical Practice and Service, 2004, (2): 88-91.
shu

Study on determination of particulate matter in small volume injections and sterile powder for injection

  • Shanghai Institute for Drug Control, Shanghai 200233, China

  • Received Date: 2003-08-22
  • Objective To establish a light observation method for determination of particulate matter in small volume injections and sterile powder for injection. Methods The average numbers of particles at≥10μm and at≥25μm in diameter in each unit were counted, using the sampling plans of the entire unit volume sample, the pooled sample and the diluting sample with an appropriate diluent. Results The different data were obtained with different sampling plans, and various results were found between two instruments. Most of parenral injection samples met the requirements, i. e. not more than 6000 at≥10μm and not more than 600 at≥25μm were found per vial. Conclusions The sampling method should be specified in the individual monographs. Small volume injections may be tested using the pooled sample and the diluting sample with an appropriate diluent and sterile powder for injection should be dissolved and diluted with the specified volume of filtered water or an appropriate filtered diluent based on consideration of product characteristics.
  • 加载中
通讯作者: 陈斌, bchen63@163.com
  • 1. 

    沈阳化工大学材料科学与工程学院 沈阳 110142

  1. 本站搜索
  2. 百度学术搜索
  3. 万方数据库搜索
  4. CNKI搜索
Get Citation
PDF
XML

Article Metrics

Article views(2788) PDF downloads(651) Cited by()

Related
Proportional views

Study on determination of particulate matter in small volume injections and sterile powder for injection

  • Shanghai Institute for Drug Control, Shanghai 200233, China
  • Received Date: 2003-08-22

Abstract: Objective To establish a light observation method for determination of particulate matter in small volume injections and sterile powder for injection. Methods The average numbers of particles at≥10μm and at≥25μm in diameter in each unit were counted, using the sampling plans of the entire unit volume sample, the pooled sample and the diluting sample with an appropriate diluent. Results The different data were obtained with different sampling plans, and various results were found between two instruments. Most of parenral injection samples met the requirements, i. e. not more than 6000 at≥10μm and not more than 600 at≥25μm were found per vial. Conclusions The sampling method should be specified in the individual monographs. Small volume injections may be tested using the pooled sample and the diluting sample with an appropriate diluent and sterile powder for injection should be dissolved and diluted with the specified volume of filtered water or an appropriate filtered diluent based on consideration of product characteristics.

CHEN Zhu-kang, PENG Xin-sheng, CHEN Gui-liang. Study on determination of particulate matter in small volume injections and sterile powder for injection[J]. Journal of Pharmaceutical Practice and Service, 2004, (2): 88-91.
Citation: CHEN Zhu-kang, PENG Xin-sheng, CHEN Gui-liang. Study on determination of particulate matter in small volume injections and sterile powder for injection[J]. Journal of Pharmaceutical Practice and Service, 2004, (2): 88-91.
shu

    HTML

Catalog

    版权所有：《药学实践与服务》编辑委员会

    Supervisor & Sponsors: Address: No 325 Guohe Road, ShanghaiPost Code: 200433

    Tel: （021）81871324,81871397 E-mail: yxsjzzs@163.com

    网站备案号 沪ICP备05003363号-1

    Supported by: Beijing Renhe Information Technology Co., Ltd.  

    /

    DownLoad:  Full-Size Img  PowerPoint
    Return
    Return