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Volume 22 Issue 2
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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.
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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.
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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.
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