Degree of Deacetylation (DDA)
GMP Parenteral
cGMP chitosan
trū Chitosan’s GMP Parenteral is a 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 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)
2–10 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)
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.