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L-Methyl Folate Calcium Analytical Specification

L-METHYL FOLATE CALCIUM
TEST SPECIFICATION
Appearance White to light yellow color
Solubility Sparingly soluble in water very slightly soluble or insoluble in most organic solvents. soluble in alkaline solution
Identification by IR The infrared absorption spectrum of the sample shall be concordant with that of the standard spectrum.
Water content (%) NMT 17
Calcium content(% w/w) 7.0 to 8.5
Residual solvents Methanol(ppm) MDC (ppm) IPA (ppm) Acetone (ppm) Chloroform(ppm) NMT 3000 NMT 600 NMT 5000 NMT 5000 NMT 60
Assay (%) Methyl folate Calcium (On dried basis) NLT 95.0
Microbial parameters Total Bacterial Count Total Fungal Count Pathogens: E.coli Salmonella P.aeruginosa NMT 1000 cfu/gm NMT 100 cfu/gm Should be absent Should be absent Should be absent
S.aureus Should be absent
Heavy metals (ppm) NMT 10