Product name:

Mycophenolate Mofetil

Empirical formula:

C₂₃H₃₁NO₇

Molecular weight:

433.50

CAS:

[115007-34-6]

Description:

White to almost white crystalline powder

Identity

    IR:

Complies

    HPLC:

Complies

    UV:

Complies

Loss on drying:

NMT 0.5%

Appearance of solution

    Clarity of solution:

Complies

    Color:

Complies

Related substances

    Mycophenolic acid:

NMT 0.3%

    Mocophenolic acid lactone:

NMT 0.1%

    Mycophenolic acid methylester:

NMT 0.1%

    Unknown individually:

NMT 0.1%

    Total impurities:

NMT 0.7%

Residual solvents

    Dichlormethane:

NMT 600 ppm

    Hexane:

NMT 100 ppm

    Ethyl acetate:

NMT 100 ppm

    Dibutyl ether:

NMT 500 ppm

    Toluene:

NMT 50 ppm

Assay (on anhydrous substance)

99.0 – 101.0%

Particle size

    10 %

NMT 10 microns

    50 %

NMT 50 microns

    90 %

NMT 100 microns

Bulk density:

Sulphated ash:

NMT 0.1%

Heavy metals:

NMT 20 ppm

Melting point:

94 – 98 °C