SPL Set ID: 21ff53b0-b4ba-4473-91e4-76ef41681064

1 drug(s) with this SPL Set ID

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Mycophenolate mofetil MYCOPHENOLATE MOFETIL
200 mg/ml Powder
ASCEND LABORATORIES, LLC FDA Rx Only

Mycophenolate mofetil is an antimetabolite immunosuppressant. It is the 2morpholinoethyl 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 (1,3dihydro-4-hydroxy-6-methoxy-7-methyl-3-oxo-5-isobenzofuranyl)-4-methyl-4-hexenoate. It has an empirical formula of C 23 H 31 NO 7 , a molecular weight of 433.50, and the following structural formula: Mycophenolate mofetil is a white to off-white crystalline powder. It is slightly soluble in water (43 mcg/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 USP for oral suspension is available for oral administration as a powder for oral suspension, which when constituted contains 200 mg/mL of mycophenolate mofetil Inactive ingredients in mycophenolate mofetil for oral solution 200 mg include Sorbitol, sodium citrate dihydrate, citric acid anhydrous, methylparaben, xanthan gum, aspartame, soybean lecithin and N &A gum fruit flavor. FDA approved dissolution test specifications differ from USP. mycophenolate-structure-.jpg

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