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CHOLINE BITARTRATE USP/FCC

COATED

(with food grade silicon dioxide)

SPECIFICATIONS

ITEM	SPECIFICATION
Appearance	White crystalline powder
Assay after conditioning	98.0 – 99.5%
Assay before conditioning	99.0 – 100.5%
pH	3.0 -4.0
Water	NMT 0.5%
Silicon Dioxide	0.6 – 1.2%
Heavy Metals	NMT 10 ppm
Arsenic	NMT 2 ppm
Lead	NMT 0.3 ppm
Infrared Spectrum	Compares to USP Standard
Total Amines	NMT 10 ppm
Total Impurities (HPLC)	Passes USP test
Organic Volatile Impurities	Passes USP test
Chromatographic Purity	Passes USP test
Optical Rotation	Between +17.5 and +18.5
Solubility	Soluble in water, slightly soluble in alcohol
MICROBIOLOGY:
Total Plate Count	1,000 CFU/g Max.
Yeast & Mold	100 CFU/g Max.
Total Coliform	10 CFU/g Max.
Enterobacteria (Sakazaki)	Negative/10 g
E. Coli	Negative/10 g
Salmonella	Negative/25g
Bacillus Cereus Spores	Negative/1g
Sulfite Reducing Clostridia	Negative/1 g
Staphylococcus	Negative / 10 g

CHOLINE BITARTRATE USP/FCC

UNCOATED

ITEMS	SPECIFICATIONS
Appearance	White crystalline, solid
Residual Solvent USP	Pass USP Requirements
Assay, % (Anhydrous)	99.0 to 100.5%
USP Identification test	Passes USP ID B
Infrared spectrum	Passes USP Test
Specific Rotation	+17.5º to +18.5º
Water	NMT 0.50%
pH (10% solution)	3.0 – 4.0
Residue on Ignition	NMT 0.1 %
Total Amines	10 ppm Max.
Chromatographic Purity	Passes USP Test
Organic Volatile Impurities	Passes USP Test
Heavy Metals (as Pb)	NMT 10 ppm
Lead	NMT 0.3 ppm
Arsenic	NMT 2 ppm
1,4 Dioxane	NMT 10 ppm
MICROBIOLOGY:
Total Plate Count	1,000 CFU/g Max.
Yeast & Mold	100 CFU/g Max.
Total Coliform	10 CFU/g Max.
Enterobacteria (Sakazaki)	Negative/10 g
E. Coli	Negative/10 g
Salmonella	Negative/25g
Bacillus Cereus Spores	Negative/1g
Sulfite Reducing Clostridia	Negative/1 g
Staphylococcus	Negative / 10 g