Category
Cilastatin
CAS Number
Cilastatin STD : 82009-34-5 ; IMP- A : NA ;IMP-B : NA; IMP-D: 141-79-7 ; IMP-E : 1174657-07-8 ; IMP-F : NA ; IMP- G : NA ; IMP-H : NA ;
Alternate CAS Number
Cilastatin STD: 81129-83-1 (Na salt)
Molecular Formula
Cilastatin STD : C16H26N2O5S ; IMP- A : C16H26N2O6S ; IMP-B : C21H34N2O6S; IMP-D : C6H10O ; IMP-E : C10H17NO5S; IMP-F : C16H26N2O5S ;IMP- G : C16H26N2O5S; I MP-H : C15H26N2O3S ;
Molecular Weight
Cilastatin STD : 358.5 g/mol ;IMP- A : 374.5 g/mol ; IMP-B : 442.6 g/mol; IMP-D : 98.2 g/mol ; IMP-E : 263.3 g/mol; IMP-F: 358.5 g/mol; MP- G : 358.5 g/mol ; IMP-H : 314.4 g/mol ;
Synonym

Cilastatin :  (Z)-7-[[(2R)-2-amino-2-carboxyethyl]sulfanyl]-2-[[[(1S)-2,2-dimethylcyclopropyl]carbonyl]amino]hept-2-enoic acid ;

Cilastatin EP Impurity A : (Z)-7-[(RS)-[(2R)-2-amino-2-carboxyethyl]sulfinyl]-2-[[[(1S)-2,2-dimethylcyclopropyl]carbonyl]amino]hept-2-enoic acid ; 

Cilastatin EP Impurity B : (Z)-7-[[(2R)-2-carboxy-2-[[(1RS)-1-methyl-3-oxobutyl]amino]ethyl]sulfanyl]-2-[[[(1S)-2,2-dimethylcyclopropyl]carbonyl]amino]hept-2-enoic acid ; 

Cilastatin EP Impurity D : 4-Methylpent-3-en-2-one ;

Cilastatin EP Impurity E : 7-[[(2R)-2-amino-2-carboxyethyl]sulfanyl]-2-oxoheptanoic acid ;

Cilastatin EP Impurity F : (Z)-7-[[(2R)-2-amino-2-carboxyethyl]sulfanyl]-2-[(2,3-dimethylbut-3-enoyl)amino]hept-2-enoic acid ;

Cilastatin EP Impurity G : (E)-(2RS)-7-[[(2R)-2-amino-2-carboxyethyl]sulfanyl]-2-[[[(1S)-2,2-dimethylcyclopropyl]carbonyl]amino]hept-3-enoic acid 

Cilastatin EP Impurity H : (Z)-7-[(2-aminoethyl)sulfanyl]-2-[[[(1S)-2,2-dimethylcyclopropyl]carbonyl]amino]hept-2-enoic acid.;

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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.

Cilastatin CRS is used as a reference standard in system suitability testing to ensure the chromatographic system operates correctly with respect to retention time and peak symmetry. It is employed to evaluate parameters such as theoretical plates, tailing factor, and %RSD, confirming the system’s suitability for analysis.