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

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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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