Sevelamer hydrochloride 152751-57-0 Sevelamer HCl
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Product name: Sevelamer hydrochloride
Other Name: Renagel, Sevelamer Hcl
CAS NO.: 152751-57-0
Standard: USP standard
MF: (C3H7N)m.(C3H5ClO)n.(HCl)x
Appearance: White crystalline powder.
Sevelamer hydrochloride is poly(allylamine hydrochloride) crosslinked with epichlorohydrin in which forty percent of the amines are protonated. It is known chemically as poly(allylamine-co-N,N'-diallyl-1,3-diamino2-hydroxypropane) hydrochloride. Sevelamer hydrochloride is hydrophilic, but insoluble in water.
Tests |
Results |
Specifications |
Appearance |
Complies |
White crystalline powder |
Identification |
Complies |
Reponds to the test for Chlorides |
|
Complies |
By IR, to match with the working standard |
Loss on Drying |
5.88% |
≤8.0% |
Residue on ignition |
0.13% |
≤0.2% |
Heavy metal |
< 20 ppm |
≤20 ppm |
Solubility test |
Complies |
Should be to match with the standard |
Related substances |
0.7ppm |
Epoxy chloropropanols ≤1ppm |
|
7.8ppm |
Allylamine ≤10ppm |
Residual solvents |
0.01% |
Methanol ≤0.3% |
|
0.03% |
Acetonitrile ≤0.041% |
Binding of Phosphate |
5.90mmol/g |
5.2~7.5mmol/g |
Conclusion: Conforms to internal specification |
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