Alginate: Current Use and Future Perspectives in Pharmaceutical and Biomedical Applications
Table 1
Sodium alginate characteristic recommended by the European Pharmacopeia (Eur. Ph.) and United States Pharmacopeia (USP) [5, 6].
Parameter
Eur. Ph. 8.0
USP 32-NF 27
Appearance of solid product
White or pale yellowish-brown powder
n.d.
Content
n.d.
90.8%–106.0% of dried basis
Packaging and storage
n.d.
preserved in tight containers
Solubility
Slowly soluble in water, practically insoluble in ethanol 96%
n.d.
Appearance of solution
Not more opalescent than reference formazin suspension in water and not more intensely coloured than intensity 6 of the range of reference solutions of the most appropriate colour
n.d.
Heavy metals
≤20 ppm
≤0.004%
Chlorides
≤1.0%
n.d.
Calcium
≤1.5%
n.d.
Arsenic
n.d.
≤1.5 ppm
Loss on drying
≤15.0%
≤15.0%
Total ash
n.d.
18.0%–27.0%
Sulfated ash
30.0%–36.0%
n.d.
Microbial limits
TAMC: ≤1000 cfu/g
≤200 cfu/g
TYMC: ≤100 cfu/g
Absence of specified microorganisms
Salmonella sp., Escherichia coli
Salmonella sp., Escherichia coli
n.d.: not determined, TAMC: total aerobic microbial count, and TYMC: total yeast/moulds count.
