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Chondroitin Sulphate Sodium Analytical Specification

CHONDROITIN SULPHATE SODIUM
TEST SPECIFICATION
Appearance Off-white powder
Solubility Soluble in water
Identification IR The infrared absorption spectrum of the sample shall be concordant with that of the standard spectrum
Specific rotation (at 250C) Between 20.0 - 30.0
pH (at 250C) 5.5 – 7.5
Loss on drying (%) (at1050C) NMT 10
Residue on ignition (%) (at 800± 250C) 20.0 - 30.0
Chlorides (%) NMT 0.5
Heavy metals (%) NMT 0.002
Residual solvents Methanol(ppm) MDC (ppm) IPA (ppm) Acetone (ppm) Chloroform(ppm) NMT 3000 NMT 600 NMT 5000 NMT 5000 NMT 60
Assay (%) Chondroitin sulfate sodium 99.0 to100.5
Microbial parameters Total Bacterial Count Total Fungal Count Pathogens E.coli Salmonella P.aeruginosa S.aureus NMT 1000 cfu/gm NMT 100 cfu/gm Should be absent Should be absent Should be absent Should be absent
Sulfates (%) NMT 0.24