Document kyMedV5oMn3z97xO81OO74ZO

InternCaolrrespondence dc: M. T. C@ase- 218-3 E. G. Lamprecht - 218,-3 W. C. McCormi,ck - 220-2E-02 V. Pothapragada - 236-3A R. A. Prokop 236-2B L. D. Winter 236-2B To: From: Subject: Date: E. G. GORTNER RIKER - 218,3-t-3 T. R. MATHISEN COMMERCIAL CHEMRCALS , 236,2B ANALYTICAL ANALYSES OF SUSPENSION OF FM-3924 April 8, 1981 INTRODUCTION: Reference: CCD Analytical Method #G-29-0381 Four samples of corn oil with suspended FM-3924 were received on March 16, 1981 from E. G. Gortner. The four samples labeled Placebo corn oil, T-2999 CDC 25 mg/kg/day FM-3924, T-2999 COC 2.,5mg/kg/day and T-2999 COC 0.25 mg/kg/day were submitted for mg/ml concentration of FM-3424, for use in a rat feeding study. The samples were run by a GLC method using a methanol extraction and an internal standard. GLC RESULTS: Sample Placebo Corn Oil T-2999 COC FM-3924 0.25 mg/kg/day T-2999 COC FM-39..24 2.5 mg/kg/day T-2999 COC FM-3924 25 mg/kg/day Mg/Ml FM-3924 No FM-3924 detected 0.0459 mg/ml FM-3924 0.4694 mg/ml FM-3924 5.136 mg/ml FM-3924 S"ARY: All samples were within 10% of target and showed good reproducibility. The solubility of FM-3924 was found to be low. Standards used show signs of saturation at 0.5 mg/ml level. It was found that sonification would dissolve the FM-3924 into the corn oil. But after several days the 5 mg/ml standard showed some crystalization,but after sonification it would re-solubilize. The crystalizationcould cause problems in the feeding study corn oil. TRM/hc