Croscarmellose sodium PARTECK®, EMPROVE® ESSENTIAL Ph. Eur., JP, NF, SAFC®
Lieferant: Merck
1.02310.9025EA
0
EUR
MERP1.02310.0500S
1.02310.9025
Croscarmellose sodium PARTECK®, EMPROVE® ESSENTIAL Ph. Eur., JP, NF, SAFC®
Croscarmellose sodium
Croscarmellose sodium is suitable for use as excipient.
Formel:
C₂₈H₃₀Na₈O₂₇ Molecular Weight: 982,44 g/mol Lagertemperatur: Raumtemperatur |
MDL:
MFCD00217760 CAS-Nummer: 74811-65-7 |
Spezifikation Testergebnisse
Identity | Passes Test |
Water-Soluble Substances | 1.0 - 10.0% |
pH-Value | 5.0 - 7.0 |
Sodium Chloride and Sodium Glycolate | ≤0.5% |
Heavy Metals (as Pb) (EP) | ≤20 ppm |
Heavy Metals (as Pb) (JP) | ≤10 ppm |
Heavy Metals (as Pb) (NF) | ≤10 ppm |
Ethanol (HS-GC) | ≤6.0% |
Other Residual Solvents (ICH Q3C) | Excluded by the Manufacturing Process |
Residue on Ignition | 14.0 - 28.0% |
Loss on Drying | ≤10.0% |
Degree of Substitution | 0.60 - 0.85 |
Settling Volume | 10.0 - 30.0 ml |
Microbiological Purity (Total Aerobic Microbial Count (TAMC)) | ≤1000 CFU/g |
Microbiological Purity (Total Yeast and Mould Count (TYMC)) | ≤100 CFU/g |
Escherichia coli (Absent in 1 g) | Passes Test |
Residues of metal catalysts or metal reagents acc. to EMENC HMP/SWP/4446/2000 are not likely to be present |
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