Particulate matter determination in LVPs produced in Dutch hospital pharmacies, Part 1: Particle-counting accuracy.
Reproducible particle counting using the light-obscuration technique is often troublesome because no absolute standard is available. Therefore, at the Laboratory of Dutch Pharmacists the "calibration-in-time" method was developed. This method enables checking of the amount of particles counted from a diluted latex suspension as a function of time. A particularity of the method is the one-step dilution procedure. The calibration-in-time method is compared with the particle-counting accuracy test according to the USP < 788 >. Advantages and disadvantages of both methods are discussed.
Van der Veen
J
J
Laboratory of Dutch Pharmacists (LNA), Den Haag, The Netherlands.
Verbrugge
P
P
Van de Vaart
F J
FJ
Boom
F A
FA
D002138:Calibration; D004340:Drug Contamination / Q000517:prevention & control; D007263:Infusions, Parenteral / Q000592:standards*; D007840:Latex / Q000737:chemistry; D009426:Netherlands; D010316:Particle Size; D010607:Pharmacy Service, Hospital / Q000592:standards*; D011786:Quality Control; D015203:Reproducibility of Results; D012996:Solutions / Q000032:analysis / Q000592:standards; D013242:Sterilization / Q000592:standards; D013535:Suspensions / Q000032:analysis / Q000592:standards*; D007507:Therapeutic Irrigation / Q000592:standards
D007840:Latex; D012996:Solutions; D013535:Suspensions