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Magnesium Stearate, NF, EP, BP, JP is used as an anti-adherent in the manufacture of of medical capsules, tablets, and powders. All Spectrum Chemical NF, BP, JP grade products are manufactured, packaged and stored under current Good Manufacturing Practices (cGMP).
TEST | MIN | MAX |
---|---|---|
APPEARANCE | ||
ASSAY (as Mg; DRIED BASIS) (NF/EP/BP/JP) | 4.0 | 5.0 % |
STEARIC ACID (NF/EP/BP/JP) | 40 % | |
STEARIC ACID AND PALMITIC ACID (NF/EP/BP/JP) | 90 % | |
ACIDITY OR ALKALINITY (NF/EP/BP/JP) | 0.05 ml | |
LOSS ON DRYING (NF/JP) | 6.0 % | |
LOSS ON DRYING (EP/BP) | 6.0 % | |
LEAD (NF/EP/BP) | 10 ppm | |
NICKEL (NF/EP/BP) | 5 ppm | |
CADMIUM (NF/EP/BP) | 3 ppm | |
CHLORIDE (NF/EP/BP/JP) | 0.1 % | |
SULFATE (NF/EP/BP/JP) | 1.0 % | |
HEAVY METALS (JP) | 20 ppm | |
ELEMENTAL IMPURITIES | AS REPORTED | |
MICROBIAL LIMITS: | ||
TOTAL AEROBIC MICROBIAL COUNT | 1000 cfu/g | |
TOTAL COMBINED MOLDS & YEASTS COUNT | 100 cfu/g | |
SALMONELLA | NEGATIVE | |
ESCHERICHIA COLI | NEGATIVE | |
IDENTIFICATION A (NF A) | POSITIVE FOR MAGNESIUM | |
IDENTIFICATION B (NF B) | RETENTION TIME OF SAMPLE CORRESPOND TO STANDARD | |
IDENTIFICATION C (EP/BP A) | 53°C | |
IDENTIFICATION D (EP/BP B) | 195 | 210 |
IDENTIFICATION E (EP/BP C) | RETENTION TIME OF SAMPLE CORRESPOND TO STANDARD | |
IDENTIFICATION F (EP/BP D) | POSITIVE FOR MAGNESIUM | |
IDENTIFICATION G (JP1) | POSITIVE FOR MAGNESIUM | |
CERTIFIED KOSHER | ||
CERTIFIED HALAL | ||
EXPIRATION DATE | ||
DATE OF MANUFACTURE | ||
MONOGRAPH EDITION | ||
MONOGRAPH EDITION. | ||
RESIDUAL SOLVENTS | AS REPORTED |