Product Data Rev.No. 22/2204/11245
Print date 10-Aug-2021
PURACAL® PP/USP
Description PURACAL is the highly soluble calcium salt of natural L-Lactic acid, which is produced by fermentation. It is a white, non-hygroscopic product. PURACAL PP/USP is a very high quality PURACAL pentahydrate powder.
Product calcium lactate
Specification Form agglomerated powder Hydrate form penta Clarity of solution passes test Color white Color fresh (10% solution) max. 3 ppm K2Cr207 Color of solution passes test Odor almost odorless Taste neutral Dirt (visual, reference) max. 6 particles Assay 99.0-101.0 % (w/w)1) Assay calcium 13.4-14.5 (d.s.) % (w/w) Stereochemical purity (L-isomer) min. 98 % Positive test for calcium passes test Positive test for lactate passes test Solubility in ethanol (95%) passes test Solubility in water (1 g/30 ml) passes test
Purity Acidity, as lactic acid max. 0.19 % (w/w) Loss on drying 22.0-27.0 % (w/w) Magnesium and alkali salts max. 0.5 % Sieve analysis max. 500 µm min. 98.0 % Sieve analysis 75 µm-425 µm min. 90.0 % Arsenic (as As) max. 1 mg/kg Chlorides max. 40 mg/kg Fluoride max. 15 mg/kg Heavy metals total max. 7 mg/kg Iron max. 25 mg/kg Lead max. 0.2 mg/kg Mercury max. 1 mg/kg Phosphates max. 50 mg/kg Sulfate max. 200 mg/kg Bromide max. 20 ppm Alkalinity passes test Barium passes test Reducing substances passes test Volatile fatty acids passes test pH (5 g product + 95 g water) 6.0-8.0
Microbiology Coliforms absent in 1g TAMC max. 10 CFU/g TYMC max. 10 CFU/g
Page 1 of 2 Product Data Rev.No. 22/2204/11245
Print date 10-Aug-2021
PURACAL® PP/USP
Physical-chemical- Chemical name Calcium-L-2-hydroxy-propionate
properties Molecular formula (anhydrous) (CH3CHOHCOO)2Ca Molecular weight 218 (anhydrous)
Regulatory / Registration CAS number 28305-25-1 (general 814-80-2) Complies with USP, EP, FCC, 231/2012/EC, JSFA, JECFA EEC Additive number E327 Calcium lactate GRAS status 21CFR184.1207 INS 327 Calcium lactate
1) on dry substance (d.s.)
Page 2 of 2