SPL Set ID: 461a252f-ff81-4e08-b256-a497b14835fa

Mycophenolate mofetil is an antimetabolite immunosuppressant. It is the 2-morpholinoethyl ester of mycophenolic acid (MPA), an immunosuppressive agent; inosine monophosphate dehydrogenase (IMPDH) inhibitor. The chemical name for mycophenolate mofetil (MMF) is 2-morpholinoethyl (E)-6-(1,3-dihydro-4-hydroxy-6-methoxy-7-methyl-3-oxo-5-isobenzofuranyl)-4-methyl-4-hexenoate. It has empirical formula of C 23 H 31 NO 7 , a molecular weight of 433.50 and the following structural formula. Mycophenolate mofetil, USP is a white to off-white crystalline powder. It is slightly soluble in water (43 µg/mL at pH 7.4); the solubility increases in acidic medium (4.27 mg/mL at pH 3.6). It is freely soluble in acetone, soluble in methanol, and sparingly soluble in ethanol. The apparent partition coefficient in 1-octanol/water (pH 7.4) buffer solution is 238. The pKa values for MMF are 5.6 for the morpholino group and 8.5 for the phenolic group. Mycophenolate mofetil hydrochloride has a solubility of 65.8 mg/mL in 5% Dextrose Injection USP (D5W). The pH of the reconstituted solution is 2.4 to 4.1. Mycophenolate mofetil for injection is the hydrochloride salt of MMF. The chemical name for the hydrochloride salt of mycophenolate mofetil is 2-morpholinoethyl (E)-6-(1,3-dihydro-4-hydroxy-6-methoxy-7-methyl-3-oxo-5-isobenzofuranyl)-4-methyl-4-hexenoate hydrochloride. It has empirical formula of C 23 H 31 NO 7 HCl and a molecular weight of 469.96. Mycophenolate mofetil for injection, USP is available as a sterile, white to off-white lyophilized powder in single-dose vials containing mycophenolate mofetil hydrochloride for administration by intravenous infusion only. Each vial contains 500 mg of mycophenolate mofetil, USP equivalent to 542 mg of mycophenolate mofetil hydrochloride. The inactive ingredients are polysorbate 80, 25 mg and citric acid anhydrous, 5 mg. Sodium hydroxide or hydrochloric acid may have been used in the manufacture of mycophenolate mofetil for injection, USP to adjust the pH. Reconstitution and dilution with 5% Dextrose Injection USP yields a slightly yellow solution of mycophenolate mofetil, 6 mg/mL [see Dosage and Administration (2.6) ]. structure