Product Overview

L-Leucine is a fermentation-derived essential branched-chain amino acid, utilized as a standard raw material in nutritional supplements and pharmaceutical manufacturing.

Technical Specifications

Category	Specification Item	Standard Value / Limit
General Information	Chemical Name	(S)-2-Amino-4-methylpentanoic acid
	CAS Number	61-90-5
	Molecular Formula	C₆H₁₃NO₂
	Molecular Weight	131.17
Physical & Commercial Properties	Appearance	White crystals or crystalline powder
	Odor & Taste	Odorless, slightly bitter taste
	Particle Size (Mesh)	Regular: 40–80 mesh; Micronized: 100–200 mesh (optional)
	Bulk Density	0.30–0.50 g/mL (Tapped: 0.50–0.70 g/mL)
Purity & Identification	Assay (Purity)	98.5%–101.5% (on dried basis)
	Specific Optical Rotation ([α]D20)	+14.9°–+17.3° (C=4, 6 mol/L HCl)
	Identification	IR spectrum matches reference; Ninhydrin reaction is positive
	State of Solution (Transmittance)	Clear and colorless; Transmittance ≥98.0% (1.0 g in 20 mL of 1 mol/L HCl at 430 nm)
	pH	5.5–7.0 (1.0 g dissolved in 100 mL of H₂O)
Impurities & Cleanness	Related Substances (Other Amino Acids)	Any individual impurity ≤0.50%; Total impurities ≤1.0%; Isoleucine ≤0.80% (Pharma Grade)
	Chloride (Cl)	≤0.02% or 0.05%
	Sulfate (SO₄)	≤0.02% or 0.03%
	Ammonium (NH₄)	≤0.02%
	Iron (Fe)	≤10 ppm or 30 ppm
	Loss on Drying	≤0.20% (105°C, 3 h)
	Residue on Ignition	≤0.10%
Safety & Microbiological Control	Heavy Metals (as Pb)	≤10 ppm (or Lead ≤3 ppm for food safety)
	Arsenic (As)	≤1 ppm or 2 ppm
	Bacterial Endotoxins	<6.0 EU/g (Pharmaceutical/Injectable Grade only)
	Total Aerobic Microbial Count (TAMC)	≤1,000 cfu/g (Food/Dietary Supplement Grade)
	Total Combined Molds and Yeasts (TYMC)	≤100 cfu/g
	E. coli / Salmonella	Negative

Quality Assurance & Certifications

ISO 22000 Amino Acid Processing
Audited facilities operate certified quality management systems tailored for commercial amino acid synthesis.

FSSC 22000 Fermentation Standards
The production site adheres to strict food safety system monitoring for branched-chain amino acids.

GMP Compliant Crystallization
Crystallization and separation processes operate under strict current Good Manufacturing Practices.

BRCGS Ingredient Audit
The processing lines meet the Global Standard for Food Safety benchmarks for dietary ingredients.

ISO 17025 Third-Party Testing
Third-party laboratories verify the specific optical rotation and assay criteria for each batch.

Manufacturing & Supply Capacity

Isomer-Specific Chiral Separation
The facility utilizes specialized industrial chromatography to separate leucine from its structural isomer, isoleucine.

High-Yield Fermentation Strains
Validated Corynebacterium glutamicum strains support stable fermentation yields during the submerged fermentation process.

Hydrophobic Crystal Milling
Industrial micronization milling delivers specified particle sizes, improving mechanical blending uniformity in dry-mix formulations.

Nitrogen-Blanketed Packaging Lines
Inline nitrogen-flushing protocols protect the crystalline structure against ambient moisture absorption during extended storage.

5,000-Ton Submerged Fermentation
Dedicated bioreactor arrays maintain an annual capacity of 5,000 metric tons for this material.

Decomplexing Purification Systems
Multi-stage decolorization and crystallization loops reduce manufacturing organic impurities and ammonium salt residues.

Applications

Application Field	How It Is Used
Sports Nutrition	Blended into pre/post-workout BCAA powder formulas.
Pharmaceuticals	Formulation ingredient in clinical IV amino acid infusions.
Dietary Supplements	Capsulated or tableted with other essential amino acids.
Functional Foods	Fortified into energy bars and meal replacement shakes.
Animal Feed	Added to specialized porcine and poultry feed rations.
Cosmetics	Integrated into skin care and hair care formulations and hair care products.

Compliance & Documentation Support

Document / Support Item	Description
DMF Type II Archival	The facility maintains an active Drug Master File for regulated pharmaceutical market access.
Batch-Specific HPLC Reports	Every shipped lot includes chromatographic profiles verifying enantiomeric purity and isomer separation.
TSE/BSE Free Statements	Official documentation certifies the exclusive use of plant-based fermentation substrates.
REACH & RoHS Registration	Chemical compliance dossiers are maintained for European compliance requirements for European industrial and cosmetic applications.
Change Control Agreements	Quality agreements guarantee advance written notice regarding any manufacturing process modifications.
Origin Traceability Mapping	Full supply chain mapping documents track feedstocks from agricultural source to finished crystal.

FAQ

Q: How does the plant reduce moisture clumping risk during coastal transit?

A: Cargo containers utilize specialized silica desiccant blankets and heat-sealed aluminum barrier liners to limit humidity variation during transport.

Q: Is granulated L-Leucine available for direct compression applications?

A: Yes, fluid-bed agglomeration processing modifies the crystal habit into free-flowing granules.

Q: Why does the powder exhibit a slight off-white variance between seasons?

A: Natural agricultural feedstock fluctuations occasionally influence the pigment matrix without affecting chromatographic purity.

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