Document oeEkyYoE66zYY9x0Gav6D3qLw

P THE UPJOHN COMPANY KALAMAZOO, MICHIGAN 49001 TELEPHONE (616) 382-4000 March iL, 1976 Office of HARRY R ALLEN, M D Manager, FDA Liaison Domestic Pharmaceutical Medical Affairs Hearing Clerk Food and Drug Administration Room L-65 5600 Fishers Lane Rockville, Maryland 20852 Dear Sir: In compliance with Federal Register Notice, Volume Lo, Number 51, March lL, 1975, P&ge 11865, titled "Asbestos-form Particles in Drugs for Parenteral Injection", we are supplying the attached memo. Very truly yours, THE UPJOHN COMPANY HRA:pjc Attachment Harry R.uLLlen, M.D. Manager, FDA Liaison cc: Mr, Clifford Broker HFD-3 2 3 Manufacturing Standards and Industry Liaison Branch Sp-Z-bl ^0071 Materials used in S.A.S. Diurnal Penicillin Readimixed 300M and S.A.S. Diurnal Penicillin Readimixed 500M: Sterile Bulk Diurnal Micronized Penicillin 1.257 Lecithin (EDP 224400) Sterile Bulk Diurnal Penicillin 47 Lecithin (EDP 225100) The following study will be set up to show the acceptability of the Scott BNR filter. Sufficient chloroform - Centrolex H solution has been filtered through a Scott BNR filter disc and a Scott #532 back up pad to produce about 40 Kg. of Sterile Bulk Diurnal Penicillin 47 Lecithin. Also, sufficient chloroform - Centrolex P solution has been filtered through a Scott BNR filter with a #532 back up pad to make 54 Kg. of Sterile Bulk Diurnal Penicillin 1.25% Lecithin. These two processed materials when.off assay will then be combined with appropriate sterile vehicles to make one production size lot of S.A.S, Diurnal Penicillin Readimixed 30GM and one 1/4 production size lot of S.A.S. Diurnal Penicillin Readimixed 500M. Three months stability should be available about August 1976 at which time the change will be approved. lad