Product Overview
L-Citrulline bulk powder for dietary supplement, pharmaceutical, and food formulations.
Technical Specifications
|
Category |
Parameter |
Specification / Typical Value |
Test / Compliance Method |
|
Purity & Quality Specs |
Assay (Purity) |
98.5% – 101.0% (on dry basis) |
Titration / HPLC |
|
Specific Optical Rotation |
[α]D20 = +24.5° to +26.8° |
Polarimetry |
|
|
State of Solution (Transmittance) |
≥98.0% |
Spectrophotometry |
|
|
Loss on Drying |
≤0.30% |
Gravimetric (105°C, 3 hours) |
|
|
Residue on Ignition (Sulfated Ash) |
≤0.10% |
Gravimetric method |
|
|
Chloride (as Cl) |
≤0.02% |
Turbidimetry |
|
|
Sulfate (as SO4) |
≤0.02% |
Turbidimetry |
|
|
Ammonium (as NH4) |
≤0.02% |
Colorimetry |
|
|
Iron (as Fe) |
≤10 ppm |
Atomic Absorption (AAS) |
|
|
Physical Properties |
pH Value |
5.0 – 7.0 |
10% aqueous solution potentiometric |
|
Solubility |
~200 g/L (20°C), freely soluble in water |
Aqueous solubility test |
|
|
Mesh Size (Particle Size) |
40 Mesh – 80 Mesh (Customizable) |
Sieve Shaker Method |
|
|
Bulk Density |
0.40 – 0.65 g/mL |
Volumetric Method |
|
|
Heavy Metals & Contaminants |
Total Heavy Metals |
≤10 ppm |
Colorimetry |
|
Lead (Pb) |
≤1.0 ppm |
ICP-MS / AAS |
|
|
Arsenic (As) |
≤1.0 ppm |
ICP-MS / AAS |
|
|
Mercury (Hg) |
≤0.1 ppm |
ICP-MS / AAS |
|
|
Cadmium (Cd) |
≤1.0 ppm |
ICP-MS / AAS |
|
|
Microbiological Limits |
Total Plate Count |
≤1,000 CFU/g |
Plate Count Agar |
|
Total Yeast & Mold |
≤100 CFU/g |
Sabouraud Dextrose Agar |
|
|
E. Coli |
Negative |
Microbial Identification |
|
|
Salmonella |
Negative |
Microbial Identification |
|
|
Staphylococcus aureus |
Negative |
Microbial Identification |
|
|
Regulatory & Compliance |
Manufacturing Method |
Microbial Fermentation |
Non-animal sourced carbohydrate raw materials |
|
Allergen Status |
Allergen Free |
Complies with FDA / EU food allergen regulations |
|
|
BSE/TSE Risk |
BSE/TSE Free |
Non-animal origin statement |
Manufacturing Capabilities
Annual Capacity
Annual output capacity is over 5,000 metric tons.
Fermentation Process
Microbial fermentation using carbohydrate substrate bioconversion control.
Automation & Control
Distributed Control Systems (DCS) monitor critical process parameters for batch control.
Refinement & Purification
Multi-stage crystallization and filtration systems are used for impurity reduction and particle specification control.
Quality Control & Testing
Analytical Instrumentation
High-performance liquid chromatography (HPLC) is used for purity assay and pharmacopeia compliance testing.
Impurity and Heavy Metal Testing
Inductively coupled plasma mass spectrometry (ICP-MS) is used to quantify heavy metals at ppm/ppb levels.
Residual Solvent Monitoring
Gas chromatography (GC) is used to detect organic solvent residues within established limits.
Batch Traceability
End-to-end documentation from raw materials to finished lots provides batch traceability.
Sample Retention
Reference samples are securely stored for long-term stability assessment and batch validation.
Third-Party Verification
Independent laboratories such as SGS or Eurofins provide Certificates of Analysis (COA) for verification.
Certifications & Compliance
|
Category |
Certification / Standard |
Compliance Statement |
|
Facility & Quality Standards |
cGMP Certified |
Manufacturing follows Current Good Manufacturing Practices for dietary ingredient production. |
|
ISO 9001 / 22000 |
Production facilities comply with international quality and food safety management standards. |
|
|
HACCP Audited |
Hazard Analysis Critical Control Point systems are implemented to manage contamination risks. |
|
|
Dietary & Market Access |
Kosher & Halal |
Production processes meet relevant religious dietary certification requirements. |
|
Non-GMO Project Verified |
Raw materials are traceable and verified as non-genetically modified. |
|
|
Vegan-Friendly |
Production lines exclude animal-derived inputs. |
|
|
Athletic Regulatory Integrity |
WADA Compliant |
Manufacturing protocols reduce cross-contamination risk with prohibited substances. |
FAQ
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