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Degree of Deacetylation (DDA)

GMP Parenteral Ultra

cGMP chitosan

trū Chitosan’s GMP Parenteral Ultra is an ultra-low endotoxin chitosan for cutaneous medical device, pharmaceutical and medical device research and development as well as veterinarian applications. trū Chitosan’s is extracted exclusively from shrimp exoskeleton raised in a captive, controlled environment free from pollution, disease, antibiotics with an industry first, complete chain of custody. trū Chitosan’s GMP Parenteral Ultra delivers the unsurpassed quality and consistent behavior required for topical medical device production and parenteral research applications.

Degree of Deacetylation (DDA)

≥85, ≤115% Label 

Certifications

Product Details

  • Substance

    Monograph

    Content

    Mercury

    ≤ 0.20 ppm (USP)

    ≤ 0.3 ppm

    Cadmium

    ≤ 0.20 ppm (USP)

    ≤ 0.2 ppm

    Arsenic

    ≤ 0.50 ppm (USP)

    ≤ 1.5 ppm

    Nickel

    ≤ 1.00 ppm (USP)

    ≤ 2.0 ppm

    Chromium

    ≤ 1.00 ppm (USP)

    ≤ 2.0 ppm

    Iron

    ≤ 10.0 ppm (USP)

    ≤ 10.0 ppm

    Lead

    ≤ 0.20 ppm (USP)

    ≤ 0.2 ppm

  • Substance

    Monograph

    Content

    Moisture

    ≤ 5.0% (USP)

    2.2%

    Residue on ignition

    ≤ 1.0% (USP)

    0.1%

    Protein

    ≤ 0.2% (USP)

    <LOD

  • Substance

    Monograph

    Content

    Endotoxins

    Relevant dosage (USP)

    ≤ 2 EU/ml

    P. aeruginosa

    Absent (USP)

    Absent

    S. aureus

    Absent (USP)

    Absent

    Aerobic plate count

    ≤  10³ cfu/g

    ≤ 10³ cfu/g

    Mold & yeast

    ≤  10² cfu/g

    ≤ 10² cfu/g

  • Appearance

    Neat, micronized powder

    Color

    White or slightly off-white

    FITR

    Comparable to standard

    USP ID B

    Forms a gelatin mass

    Solubility

    1% loading (in 1% acetic acid)

    Appearance in Solution

    Clear (in 1% acetic acid)

  • Quality Management

    ISO 9001

    Certificate C0497865-IS

    FDA Registration

    3014735278

    Parimer Scientific

    Easley, South Carolina, USA

    SC Board of Pharmacy

    19735

    Manufacturer

    trū Chitosan, a division of Iterro, Inc.

    Balaton, Minnesota, USA

≥70 to ≤99%
Molecular weight (MW)

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Why trū Chitosan?

It’s simple: because no other chitosan producer has as much control over the finished product as we do. Since we raise our own shrimp through our patented process, we can ensure the highest possible product quality in every batch.

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