Cleaner residue research project

16th June 2016

Posted By Paul Boughton

cleaning validation, HPLC-CAD, Micro A07 Citric Acid Cleaner
End users of the Micro A07 Citric Acid Cleaner will benefit from this research

Jennifer Sun reports on the development of a cleaning validation method using HPLC-CAD

A high performance liquid chromatography (HPLC) method with a Corona Charged Aerosol detector for the cleaning validation of Micro A07 Citric Acid Cleaner residue has been developed.

The pooled average repeatability of three replicates at six concentration levels expressed as RSD was 1.3 % while the pooled average intermediate precision (intra-day repeatability in three days) of three replicates at six concentration levels was 2.4%. Simulated maximum allowable carryover (MAC) was calculated by using 10ppm of Micro A07 Citric Acid Cleaner in a tablet of 1,000mg. With this MAC value, the amount of cleaner applied to a stainless steel surface was calculated. The swabbed cleaner samples were quantified by this HPLC-CAD method and the average recovery of five replicates of swabbed samples from stainless steel surfaces was about 92 % ± 2%.

The accuracy of the method was expressed as correlation coefficient, which was 99.7% by using all three sets of three replicates at six concentration levels in three days. The limit of detection (LOD) and limit of quantification (LOQ) were found to be 60ng and 189ng respectively, by using the three times and ten times standard deviation of a matrix blank run.

The value of LOD was verified by running a real sample. Specificity of the method was evaluated by conducting separation of blanks, the samples matrix, and placebos (common drug excipients) plus recovery sample mixture spiked with Micro A07 Citric Acid Cleaner.

The result shows good resolution and absence of interference to the targeted peaks from the matrices and placebos. This method is designed for use in Food and Drug Administration (FDA) regulated establishments in compliance with good manufacturing practice (GMP).  Citric acid in Micro A07 Citric Acid

Cleaner served as a probe in the detection of cleaner residue.

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Jennifer Sun is a research scientist at International Products Corporation (IPCOL). 



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