Product Overview

A USP/EP-grade L-Arginine produced through microbial fermentation for pharmaceutical and dietary supplement applications.

Technical Specifications

Parameter Category	Test Item	Specification / Limit
Physical & Chemical Properties	Appearance	White or almost white crystalline powder or colorless crystals
	Assay (Purity, on dried basis)	99.0%–101.0%
	Specific Optical Rotation [α]D20	+26.9° to +27.9°
	State of Solution (Clarity)	Clear and colorless (≥98.0% transmittance)
	pH Value (1% aqueous solution)	10.5–12.0
	Loss on Drying	≤0.50%
	Residue on Ignition (Sulfated Ash)	≤0.10%
Purity & Impurity Control	Ammonium (NH₄)	≤0.02%
	Chloride (Cl)	≤0.02%
	Sulfate (SO₄)	≤0.02%
	Iron (Fe)	≤10 ppm
	Related Substances (Other Amino Acids)	Individual Impurity: ≤0.5%; Total Impurities: ≤2.0%
Heavy Metals Control	Total Heavy Metals (as Pb)	≤10 ppm
	Lead (Pb)	≤1.0 ppm
	Arsenic (As)	≤1.0 ppm
	Mercury (Hg)	≤0.1 ppm
	Cadmium (Cd)	≤1.0 ppm
Microbiological Limits	Total Aerobic Microbial Count (TAMC)	≤1,000 cfu/g
	Total Combined Yeasts/Molds (TYMC)	≤100 cfu/g
	Escherichia coli	Negative / 10 g
	Salmonella spp.	Negative / 25 g
	Staphylococcus aureus	Negative / 10 g
Physical Performance	Particle Size (Mesh Options)*	40–80 mesh (Standard Powder); 100 mesh / 200 mesh (Fine Powder); 20–40 mesh (Granular)
	Bulk Density	0.45–0.65 g/mL
	Tapped Density	0.65–0.85 g/mL

Quality & Compliance

Regulatory Accreditations
Facility maintains ISO 22000, HACCP, Kosher, and Halal certifications.

Monograph Alignment
Analytical parameters follow USP, EP, and AJI monograph requirements.

Instrumentation Verification
In-house QA laboratories use HPLC, GC, and ICP-MS for batch testing.

Documentation Transparency
Batch traceability records and change control documents are available upon request.

Audit Accessibility
Onsite inspections and third-party quality audits can be arranged.

Manufacturing Capabilities

Fermentation Process Control
Automated pH control systems support stable fermentation conditions.

Crystallization Control
Multi-stage cooling systems help maintain consistent crystal formation.

Enclosed Material Transfer
Enclosed transfer systems reduce exposure to environmental moisture.

Humidity-Controlled Processing
Humidity-controlled areas support powder processing operations.

Automated Packaging
Automated sealing systems help maintain packaging integrity during storage.

Applications

Sector	Method of Incorporation
Sports Nutrition	Blended into pre-workout dry powder mixes.
Dietary Supplements	Compressed into solid tablets or encapsulated.
Pharmaceuticals	Used in pharmaceutical formulation processes.
Functional Food	Formulated into protein bars and therapeutic beverages.
Animal Nutrition	Added to crystalline amino acid feed premixes.

FAQ

Q: What raw materials are used during fermentation?

A: Plant-derived carbohydrate sources are commonly used during fermentation.

Q: How is product quality maintained during shipment?
A: Sealed packaging and controlled handling help maintain product condition.

Q: Can different particle sizes be supplied?

A: Different mesh grades may be available based on application requirements.

Q: How is cross-contamination controlled during production?

A: Equipment management and documented cleaning procedures are applied between production runs.

Q: How is moisture exposure managed during transportation?

A: Moisture-control measures may be used based on shipping conditions.

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