Product name:

Cyclosporine

Empirical formula:

C₆₂H₁₁₁N₁₁O₁₂

Molecular weight:

1202.6

CAS:

[59865-13-3]

Description:

White or almost white powder

Identity

    HPLC:

Rt of the major peak corresponds to the standard

Loss on drying:

NMT 2.0%

Heavy metals:

NMT 0.002%

Particle size

    Less than 100 μm:

NLT 90%

    Less than 50 μm:

NLT 50%

Assay

    In dried substance (HPLC):

98.5 – 101.5%

Related substances

    [Abu]5 Cyclosporine:

NMT 0.70%

    Cyclosporine U:

NMT 0.70%

    Cyclosporine H:

NMT 0.70%

    Dihydrocyclosporine A + Cyclosporine V:

NMT 0.70%

    Cyclosporine D:

NMT 0.70%

    Isocyclosporine A:

NMT 0.70%

    Largest individual unidentified impurity (HPLC):

NMT 0.10%

    Sum of impurities:

NMT 1.50%

Residual solvents

    Acetone:

NMT 5,000 ppm

    Methanol:

NMT 3,000 ppm

    Toluene:

NMT 890 ppm

    Hexane:

NMT 290 ppm

    Ethyl acetate:

NMT 5,000 ppm