RT Journal Article
SR Electronic
T1 An Approach to Setting Particulate Matter Standards for Small Volume Parenterals
JF PDA Journal of Pharmaceutical Science and Technology
JO PDA J Pharm Sci Technol
FD Parenteral Drug Association (PDA)
SP 2
OP 13
VO 40
IS 1
A1 Deluca, Patrick  P.
A1 Boddapati, Sam
A1 Haack, Dennis
A1 Schroeder, Hans
YR 1986
UL http://journal.pda.org/content/40/1/2.abstract
AB Microscopic monitoring of 50 commercial products comprising five distinct product types revealed that the particle levels were quite different. Dry products and multidose vials showed high counts while the large volume parenterals and prefilled syringes were relatively clean. The log-log plot was found to be the most appropriate plotting technique for all product types. By plotting all the data for each product type a mean curve was obtained. From the mean a 90% distribution curve was calculated. This curve was parallel to the mean curve suggesting its suitability as a standard. The proposed USP standard for small volume parenterals which covers all product types using a light blockage technique is criticized and a proposal for selecting and monitoring samples on a product type basis is presented.