Catégorie
Ciclosporin (Cyclosporine)
Numéro CAS
Cyclosporin STD-59865-13-3: IMP-B-59865-15-5: IMP-D-108027-45-8: IMP-E-108027-46-9: IMP-G-63775-96-2
Formule moléculaire
Cyclosporin STD-C62H111N11O12: IMP-B-C62H113N11O12: IMP-D-C61H109N11O12: IMP-E-C63H113N11O12: IMP-G-C63H113N11O12
Masse moléculaire
Cyclosporin STD-1202.61: IMP-B-1204.6: IMP-D-1188.6: IMP-E-1216.66: IMP-G-1216.6 g/mol
Synonyme

Cyclosporin STD-(3S,6S,9S,12R,15S,18S,21S,24S,30S,33S)-30-ethyl-33-[(E,1R,2R)-1-hydroxy-2-methylhex-4-enyl]-1,4,7,10,12,15,19,25,28-nonamethyl-6,9,18,24-tetrakis(2-methylpropyl)-3,21-di(propan-2-yl)-1,4,7,10,13,16,19,22,25,28,31-undecazacyclotritriacontane-2,5,8,11,14,17,20,23,26,29,32-undecone; Cyclosporine; Ciclosporin; Atopica; Sandimmun(e); Neoral; Optimmune; Restasis; Cyclosporin A; 1,11-Anhydro[L-alanyl-d-alanyl-N-methyl-L-leucyl-N-methyl-L-leucyl-N-methyl-L-valyl-(2S,3R,4R,6E)-3-hydroxy-4-methyl-2-(methylamino)oct-6-enoyl-(2S)-2-aminobutanoyl-N-methylglycyl-N-methyl-L-leucyl-L-valyl-N-methyl-L-leucine] (as per EP) ; Cyclo[[(E)-(2S,3R,4R)-3-hydroxy-4-methyl-2-(methylamino)oct-6-enoyl]-l-2-aminobutyryl-N-methylglycyl-N-methyl-l-leucyl-l-valyl-N-methyl-l-leucyl-l-alanyl-d-alanyl-N-methyl-l-leucyl-N-methyl-l-leucyl-N-methyl-l-valyl] (as per USP)

Cyclosporin EP-Impurity-B-(3S,6S,9S,12R,15S,18S,21S,24S,30S,33S)-30-ethyl-33-[(1R,2R)-1-hydroxy-2-methylhexyl]-1,4,7,10,12,15,19,25,28-nonamethyl-6,9,18,24-tetrakis(2-methylpropyl)-3,21-di(propan-2-yl)-1,4,7,10,13,16,19,22,25,28,31-undecazacyclotritriacontane-2,5,8,11,14,17,20,23,26,29,32-undecone

Cyclosporin EP-Impurity-D-(3S,6S,9S,12R,15S,18S,21S,24S,30S,33S)-30-ethyl-33-[(E,1R,2R)-1-hydroxy-2-methylhex-4-enyl]-1,4,7,10,12,15,25,28-octamethyl-6,9,18,24-tetrakis(2-methylpropyl)-3,21-di(propan-2-yl)-1,4,7,10,13,16,19,22,25,28,31-undecazacyclotritriacontane-2,5,8,11,14,17,20,23,26,29,32-undecone

Cyclosporin EP-Impurity-E-(3S,6S,9S,12R,15S,18S,21S,24S,30S,33S)-15,30-diethyl-33-[(E,1R,2R)-1-hydroxy-2-methylhex-4-enyl]-1,4,7,10,12,19,25,28-octamethyl-6,9,18,24-tetrakis(2-methylpropyl)-3,21-di(propan-2-yl)-1,4,7,10,13,16,19,22,25,28,31-undecazacyclotritriacontane-2,5,8,11,14,17,20,23,26,29,32-undecone

Cyclosporin EP-Impurity-G- (3S,6S,9S,12R,15S,18S,21S,24S,30S,33S)-33-[(E,1R,2R)-1-hydroxy-2-methylhex-4-enyl]-1,4,7,10,12,15,19,25,28-nonamethyl-6,9,18,24-tetrakis(2-methylpropyl)-3,21,30-tri(propan-2-yl)-1,4,7,10,13,16,19,22,25,28,31-undecazacyclotritriacontane-2,5,8,11,14,17,20,23,26,29,32-undecone

slide.1
Purity:

Above - 95.0%

Technical Data:

We will provide complete documentation support for every Standard Material. All analytical reports such as ¹H NMR, ¹³C NMR, Mass, FT-IR, HPLC Purity/GC Purity/QNMR Purity, Water content by KF/ Loss on Drying/TGA (Thermo-gravimetric Analysis). Certificate of Analysis with potency report. Each Standard Material SER (Structure Elucidation Report) with NMR, Mass, IR spectral interpretation. This whole analytical document can be included in eCTD, ANDA, DMF submissions to regulatory agencies.

Ciclosporin for System Suitability A CRS is a European Pharmacopoeia reference standard used in quality control testing of ciclosporin (cyclosporin) products. It is specifically intended for system suitability tests in chromatographic assays, ensuring that the analytical system (e.g., HPLC) is performing correctly before measuring the actual sample. This helps verify accuracy, precision, and reliability of the assay results.