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    Puralcal PDS PDF

    Uploaded by

    Joseph Montoya
    This document provides product data and specifications for PURACAL PP/USP, a highly soluble calcium salt of natural L-Lactic acid produced by fermentation. It is a white, non-hygroscopic, agglomerated powder. The document lists detailed information on the product's description, specifications, purity, microbiology, physical and chemical properties, and regulatory compliance.

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    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd

    Puralcal PDS PDF

    Uploaded by

    Joseph Montoya
    6 views2 pages
    This document provides product data and specifications for PURACAL PP/USP, a highly soluble calcium salt of natural L-Lactic acid produced by fermentation. It is a white, non-hygroscopic, agglomerated powder. The document lists detailed information on the product's description, specifications, purity, microbiology, physical and chemical properties, and regulatory compliance.

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    PURALCAL PDS PDF

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    This document provides product data and specifications for PURACAL PP/USP, a highly soluble calcium salt of natural L-Lactic acid produced by fermentation. It is a white, non-hygroscopic, agglomerated powder. The document lists detailed information on the product's description, specifications, purity, microbiology, physical and chemical properties, and regulatory compliance.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    6 views2 pages

    Puralcal PDS PDF

    Uploaded by

    Joseph Montoya
    This document provides product data and specifications for PURACAL PP/USP, a highly soluble calcium salt of natural L-Lactic acid produced by fermentation. It is a white, non-hygroscopic, agglomerated powder. The document lists detailed information on the product's description, specifications, purity, microbiology, physical and chemical properties, and regulatory compliance.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    of 2

    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

    Wed Jan 10 12:41:36 COT 2024


    Maria Camargo
    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) (CH CHOHCOO) Ca
    3 2

    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

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