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Degree of Deacetylation (DDA)

GMP Parenteral Ultra

USP 232 Parenteral Conforming

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

Undetectable Endotoxins

When tested according to strict USP monograph guidelines, the product's pyrogenic material is less than the minimum Limit of Detection (LOD).

cGMP Production

Adherence to FDA requisite current Good Manufacturing Practices (cGMP) assures consistent identity, characteristics, purity, and most importantly behavior of a component of drug products by requiring that manufacturers of medications adequately control manufacturing operations through proper monitoring and design.

FDA-Registered Production

Registration with the U.S. Food & Drug Administration (FDA) submits a facility to routine inspection by an expert evaluator and timely investigation of any reported issues with manufactured products.

Certificate of Analysis Provided

Using the criteria and testing protocols specified by the USP-NF monograph as its foundation, trū Chitosan provides a documented and signed comprehensive Certificate of Analysis that confirms the identity, key characteristics, and impurity levels for each individual lot of trū Chitosan.

Documented Chain of Custody

Shrimp exoskeleton tissue is an approved source for USP conforming chitosan. trū Chitosan is produced exclusively from exoskeleton tissue harvested from shrimp grown with in our own captive, controlled indoor shrimp production facilities enabling chain of custody from a shrimp cohort producing the exoskeleton raw material to finished chitosan and every step in between fully documented by an industry exclusive and comprehensive Certificate of Origin.

A Product of the USA

From growing the shrimp to harvesting the exoskeleton to extraction, refinement, and analysis, trū Chitosan is the only producer of medical-application chitosan within the United States.

Product Details

  • Substance

    Monograph

    Typical Assay

    Lead

    ≤ 0.20 ppm (USP)

    0.03 ppm

    Mercury

    ≤ 0.20 ppm (USP)

    0.00 ppm

    Cadmium

    ≤ 0.20 ppm (USP)

    0.08 ppm

    Arsenic

    ≤ 0.50 ppm (USP)

    0.00 ppm

    Nickel

    ≤ 1.00 ppm (USP)

    0.90 ppm

    Chromium

    ≤ 1.00 ppm (USP)

    0.90 ppm

    Iron

    ≤ 10.0 ppm (USP)

    < 1.8 ppm

  • Substance

    Monograph

    Typical Assay

    Moisture

    ≤ 5.0% (USP)

    2.3%

    Residue on ignition

    ≤ 1.0% (USP)

    0.26%

    Protein

    ≤ 0.2% (USP)

    <LOD

  • Substance

    Monograph

    Typical Assay

    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

    FTIR

    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)

  • FDA Registration

    3014735278

    Parimer Scientific

    Easley, South Carolina, USA

    Quality Management

    ISO 9001

    Certificate C0497865-IS

    SC Board of Pharmacy

    19735

    Manufacturer

    trū Chitosan, a division of Iterro, Inc.

    Balaton, Minnesota, USA

≥70 to ≤95%
Molecular weight (MW)

Let's talk chitosan.

Our experienced chitosan pros are here to provide detailed information and help assess your unique needs.

Contact Us

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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