Cyclosporine

Cyclosporine a cyclic peptide from an extract of soil fungi that selectively inhibits T cell function; used as an immunosuppressant to prevent rejection in organ transplant recipients and to treat severe psoriasis and severe rheumatoid arthritis.

Structure
Molecular C62H111N11O12
Molecular Weight 1202.61
Chemical Name 1/C62H111N11O12/c1-25-27-28-40(15)52(75)51-56(79)65-43(26-2)58(81)67(18)33- 48(74)68(19)44(29-34(3)4)55(78)66-49(38(11)12)61(84)69(20)45(30-35(5)6)54(77)63- 41(16)53(76)64-42(17)57(80)70(21)46(31-36(7)8)59(82)71(22)47(32- 37(9)10)60(83)72(23)50(39(13)14)62(85)73(51)24/h25,27,34-47,49-52,75H,26,28-33H2,1-24H3, (H,63,77)(H,64,76)(H,65,79)(H,66,78)/b27-25+
Therapeutic Category Immunology
CAS# 59865-13-3
AbbVie US Drug Master File (DMF) 013800
Packaging Tight, light resistant containers at controlled room temperature (15° to 30°C); desiccated
Shelf Life 4 years
Specifications
Test Name Acceptance Criteria
Appearance Powder, some lumps may be present
Color White to essentially white
Assay (By HPLC) 98.5 - 101.5 %, calculated on the dried basis
Impurities (by HPLC) - Total ≤ 1.5 %
Impurities (by HPLC) - Any Largest Single Impurity ≤ 0.7 %
Identification (by HPLC) The main peak of the sample preparation shall have a similar retention time and peak response to that of the respective peak in the standard preparation
Loss on Drying ≤ 2.0 %
Appearance of Solution (Color), EP The solution is not more intensely colored than reference solution Y5, BY5 or R7
Appearance of Solution (Clarity), EP The solution is clear
Specific Optical Rotation, EP Between -193° to -185° calculated with reference to the anhydrous substance
Identification (by IR), EP The maxima in the sample spectrum correspond in position and relative intensity to those in the spectrum obtained from a similar preparation of Cyclosporine reference standard
Heavy Metals (as Pb): Method II, USP ≤ 0.002 %
Residual Solvents (by GC), Acetone (%) ≤ 0.09 %
Residual Solvents (by GC), Hexanes (%) ≤ 0.1 %
Residual Solvents (by GC) - Acetone (ppm) ≤ 1000 ppm
Residual Solvents (by GC) - Hexanes (ppm) ≤ 1499 ppm
Heavy Metals - Method C (EP) ≤ 20 ppm
Total Aerobic Microbial Count by Pour-Plate Method ≤ 2000 CFU/g
Total Yeast and Mold Count by Pour- Plate Method ≤ 200 CFU/g