Degree of Deacetylation (DDA)
Pharma
cGMP & USP-NF chitosan
Pharma is formulated exclusively from shrimp raised in a controlled environment free from pollution, disease or antibiotics. As a result, trū Chitosan delivers the unsurpassed quality and batch consistency required by medical professionals and researchers alike.
Degree of Deacetylation (DDA)
≥85, ≤115% Label
Certifications
USP-NF Conforming
The United States Pharmacopeia-National Formulary (USP-NF) sets FDA-enforceable standards for medicines, dosage forms, drug substances, excipients, biologics, compounded preparations, medical devices, dietary supplements and other therapeutics.
CGMP Compliant
Adherence to Current Good Manufacturing Practice (CGMP) assures consistent identity, strength, quality and purity 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 Included
An official Certificate of Analysis provides supplier information, material identification, transportation data, evidence of conformance and a signature attesting that it follows all guidelines set forth the by the FDA.
Documented Chain of Custody
All chitosan products are derived from shrimp grown with in our captive, controlled indoor shrimp production facilities and can be traced completely from start to finish.
Formulated in the USA
trū Chitosan is the only producer of chitosan grown, harvested, synthesized and produced entirely within the United States.
Product Details
Substance
Monograph
Content
Mercury
≤ 0.20 ppm (USP)
≤ 0.20 ppm
Cadmium
≤ 0.20 ppm (USP)
≤ 0.20 ppm
Arsenic
≤ 0.50 ppm (USP)
≤ 0.50 ppm
Nickel
≤ 1.00 ppm (USP)
≤ 1.00 ppm
Chromium
≤ 1.00 ppm (USP)
≤ 1.00 ppm
Iron
≤ 10.0 ppm (USP)
≤ 6.00 ppm
Lead
≤ 0.20 ppm (USP)
≤ 0.20 ppm
Substance
Monograph
Content
Moisture
≤ 5.0% (USP)
≤4.4%
Residue on ignition
≤ 1.0% (USP)
≤ 0.1%
Protein
≤ 0.2% (USP)
≤ 0.1%
Substance
Monograph
Content
Endotoxins
Relevant dosage (USP)
Relevant dosage
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)
Let's talk chitosan.
Our experienced chitosan pros are here to provide detailed information and help assess your unique needs.
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.