Abstract
Our evaluation of electronic liquid-borne particle counter systems has shown that, for accurate measurement of particulate matter in injections, the half count values of voltage thresholds from the particle counter itself should be used in the calibration for the particle sizes being evaluated. The manual method which uses the half count values in the USP XXIII was improved, and the validity of our calibration method was supported by the results based on the ratio test, at 10 μm to those obtained at 15 μm is between 1.5 and 3.5, as per the Seventh Supplement of USP XXII . Additionally, computer-based systems with automated calibration routines which solve the approximate Gaussian distribution of calibration particles have advantages. For the proper determination of the sizing accuracy of a particle counter, criteria of the ratio test at 10 μm and 15 μm as per the Seventh Supplement of USP XXII should be applied at all critical particle sizes.
| Original language | English |
|---|---|
| Pages (from-to) | 267-271 |
| Number of pages | 5 |
| Journal | Journal of pharmaceutical science and technology : the official journal of PDA |
| Volume | 49 |
| Issue number | 6 |
| Publication status | Published - 1995 |
| Externally published | Yes |
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ASJC Scopus subject areas
- Pharmaceutical Science
Cite this
The evaluation of sizing accuracy of particle counters for parenteral drugs. / Fujishita, O.; Sendo, Toshiaki; Hisazumi, A.; Otsubo, K.; Aoyama, T.; Oishi, R.
In: Journal of pharmaceutical science and technology : the official journal of PDA, Vol. 49, No. 6, 1995, p. 267-271.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - The evaluation of sizing accuracy of particle counters for parenteral drugs
AU - Fujishita, O.
AU - Sendo, Toshiaki
AU - Hisazumi, A.
AU - Otsubo, K.
AU - Aoyama, T.
AU - Oishi, R.
PY - 1995
Y1 - 1995
N2 - Our evaluation of electronic liquid-borne particle counter systems has shown that, for accurate measurement of particulate matter in injections, the half count values of voltage thresholds from the particle counter itself should be used in the calibration for the particle sizes being evaluated. The manual method which uses the half count values in the USP XXIII was improved, and the validity of our calibration method was supported by the results based on the ratio test, at 10 μm to those obtained at 15 μm is between 1.5 and 3.5, as per the Seventh Supplement of USP XXII . Additionally, computer-based systems with automated calibration routines which solve the approximate Gaussian distribution of calibration particles have advantages. For the proper determination of the sizing accuracy of a particle counter, criteria of the ratio test at 10 μm and 15 μm as per the Seventh Supplement of USP XXII should be applied at all critical particle sizes.
AB - Our evaluation of electronic liquid-borne particle counter systems has shown that, for accurate measurement of particulate matter in injections, the half count values of voltage thresholds from the particle counter itself should be used in the calibration for the particle sizes being evaluated. The manual method which uses the half count values in the USP XXIII was improved, and the validity of our calibration method was supported by the results based on the ratio test, at 10 μm to those obtained at 15 μm is between 1.5 and 3.5, as per the Seventh Supplement of USP XXII . Additionally, computer-based systems with automated calibration routines which solve the approximate Gaussian distribution of calibration particles have advantages. For the proper determination of the sizing accuracy of a particle counter, criteria of the ratio test at 10 μm and 15 μm as per the Seventh Supplement of USP XXII should be applied at all critical particle sizes.
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UR - http://www.scopus.com/inward/citedby.url?scp=0029610579&partnerID=8YFLogxK
M3 - Article
VL - 49
SP - 267
EP - 271
JO - Journal of pharmaceutical science and technology : the official journal of PDA
JF - Journal of pharmaceutical science and technology : the official journal of PDA
SN - 1076-397X
IS - 6
ER -