YAKUGAKU ZASSHI
Online ISSN : 1347-5231
Print ISSN : 0031-6903
ISSN-L : 0031-6903
輸液の不溶性微粒子に関する新清浄度評価法
辻 澄子伊阪 博
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1987 年 107 巻 3 号 p. 238-244

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A particulate matter content in prepared ultraclean water was determined. The particle size distributions in ultraclean water was described by a straight-line equation as well as parenteral solutions. A multi-point standard of ultraclean water and ultraclean solvent was proposed. New cleanliness factors, based on the particle-size distribution of this standard, for assessing the particulate matter content in a large-volume parenteral solution were developed and tested. Cleanliness factors were compared with another parameter and there were rank-order correlation among these parameter for cleanliness of parenteral solution, especially highly between the cleanliness factor and commulative number of particles at a diameter of 2.0 μm. Cleanliness control of parenteral solution by using these cleanliness factors is proposed as a worth-while quality control.

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© by the PHARMACEUTICAL SOCIETY OF JAPAN
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