24 ANALYTICAL AND LABORATORY EQUIPMENT
CLEANER RESIDUE research project
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. T e 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. T e swabbed cleaner samples were quantifi ed by this HPLC-CAD method and the average recovery of fi ve replicates of swabbed samples from stainless steel surfaces was about 92 % ± 2%. T e accuracy of the method
was expressed as correlation coeffi cient, which was 99.7% by using all three sets of three replicates at six concentration levels in three days. T e limit of detection (LOD) and limit of quantifi cation (LOQ) were found to be 60ng and 189ng respectively, by using the three times and ten times standard deviation of a matrix blank run. T e value of LOD was
verifi ed by running a real sample. Specifi city 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.
T e result
shows good resolution and absence of interference to the targeted peaks from the matrices and placebos. T is 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.
For more information ✔ at
www.scientistlive.com/eurolab
End users of the Micro A07 Citric Acid Cleaner will benefi t from this research
Jennifer Sun is a research scientist at International Products Corporation (IPCOL).
www.ipcol.com
www.scientistlive.com This recent research project used an HPLC-CAD method for quantifying swabbed cleaner samples
Page 1 |
Page 2 |
Page 3 |
Page 4 |
Page 5 |
Page 6 |
Page 7 |
Page 8 |
Page 9 |
Page 10 |
Page 11 |
Page 12 |
Page 13 |
Page 14 |
Page 15 |
Page 16 |
Page 17 |
Page 18 |
Page 19 |
Page 20 |
Page 21 |
Page 22 |
Page 23 |
Page 24 |
Page 25 |
Page 26 |
Page 27 |
Page 28 |
Page 29 |
Page 30 |
Page 31 |
Page 32 |
Page 33 |
Page 34 |
Page 35 |
Page 36 |
Page 37 |
Page 38 |
Page 39 |
Page 40 |
Page 41 |
Page 42 |
Page 43 |
Page 44 |
Page 45 |
Page 46 |
Page 47 |
Page 48 |
Page 49 |
Page 50 |
Page 51 |
Page 52 |
Page 53 |
Page 54 |
Page 55 |
Page 56 |
Page 57 |
Page 58 |
Page 59 |
Page 60 |
Page 61 |
Page 62 |
Page 63 |
Page 64 |
Page 65 |
Page 66 |
Page 67 |
Page 68 |
Page 69 |
Page 70 |
Page 71 |
Page 72 |
Page 73 |
Page 74 |
Page 75 |
Page 76 |
Page 77 |
Page 78 |
Page 79 |
Page 80 |
Page 81 |
Page 82 |
Page 83 |
Page 84