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Diethylenetriaminepentaacetic Acid Calcium and Trisodium Salt x-hydrate (Ph. Eur.) low endotoxin IPEC grade

Calcium Trisodium Pentetate x-hydrate, DPTA Calcium and Trisodium Salt x-hydrate

Assay (Compl.) (a.a.s.): 98.0-100.5 %
Code
Z4C393
CAS
12111-24-9
Molecular Formula
C14H18CaN3Na3O10.xH2O
Masse molaire
497.35 +xH20 g/mol
Solubility:
Soluble in water.
Physical Description:
solid
Product Code:
Z4C393
Product Name:
Diethylenetriaminepentaacetic Acid Calcium and Trisodium Salt x-hydrate (Ph. Eur.) low endotoxin IPEC grade
Quality Name:
low endotoxin IPEC grade
Specifications:
Assay (Compl.) (a.a.s.): 98.0-100.5 %
Identity according to Pharmacopoeia:
A: IR passes test
B Calcium: passes test
C Sodium: passes test
pH of 20% solution: 8.0-9.5

Maximum limit of impurities
Appearance of solution
Appearance Transparent < formazin I < 3 NTU: passes test
Appearance Colourless < B9: passes test
Chloride (Cl): 0.1%
Microbial Limits
Bacterial endotoxins: 0.1 IU/mg
Other Residual solvents (Ph.Eur.): passes test
Impurity B - Diethylentriaminepentaacetic Acid: 1.0%
Impurity A - Nitrilotriacetic Acid (HPLC.): 0.1%
Methanol: 0.3%
Water (H2O): 9.0-15.0 %
Ba: 0.001 %
Fe: 0.0020 %
K: 0.05 %
Mg: 0.05 %
Ni: 0.0005 %
Sr: 0.01 %
Zn: 0.0005 %
Storage:
Storage away from direct light.
Master Name:
Diethylenetriaminepentaacetic Acid Calcium and Trisodium Salt x-hydrate
Synonyms Long Text:
Calcium Trisodium Pentetate x-hydrate, DPTA Calcium and Trisodium Salt x-hydrate
EINECS:
235-169-1
CS:
2922 49 85 90
Télécharger le fichier TDS pour les spécifications complètes