Journal of Pharmaceutical Investigation

The Korean Society of Pharmaceutical Sciences and Technology (한국약제학회)
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Tests for Volume of Injections in Containers

주사제의 실용량시험법에 관한 조사

  • Choi, Myung-Hee (Division of Drug Standardization, Drug Evaluation Department, Korean Food and Drug Administration) ;
  • Park, Seung-Hee (Division of Drug Standardization, Drug Evaluation Department, Korean Food and Drug Administration) ;
  • Choi, Bo-Kyung (Division of Drug Standardization, Drug Evaluation Department, Korean Food and Drug Administration) ;
  • Kang, Chan-Soon (Division of Drug Standardization, Drug Evaluation Department, Korean Food and Drug Administration) ;
  • Lee, Suk-Ho (Division of Drug Standardization, Drug Evaluation Department, Korean Food and Drug Administration) ;
  • Kim, Kil-Soo
  • 최명희 (식품의약품안전청 의약품평가부 약품규격과) ;
  • 박승희 (식품의약품안전청 의약품평가부 약품규격과) ;
  • 최보경 (식품의약품안전청 의약품평가부 약품규격과) ;
  • 강찬순 (식품의약품안전청 의약품평가부 약품규격과) ;
  • 이석호 (식품의약품안전청 의약품평가부 약품규격과) ;
  • 김길수 (이화여대 약대)
  • Published : 2000.09.20
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Abstract

Testing the volume of injection in container is to ensure that the nominal content of a container can be administered to the patient. The method to test the volume of injection in container is described in European Pharmacopeia (EP) and United States Pharmacopeia (USP). However there is no method to test the volume of injection in Korean Pharmacopeia (KP). So we surveyed the method practiced by 53 pharmaceutical companies in Korea by a questionnaire and tested commercially available injections by discharged volume. As the result, we agreed with the International Conference on Harmonization (ICH) test method for discharged volume. It was suggested that the ICH test method for discharged volume of injection in container would be adopted.

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