Acetyl-L-Carnitine Hydrochloride (ALCAR HCl)
Acetyl-L-Carnitine Hydrochloride is a high-purity, synthetically derived amino acid salt designed for integration into advanced weight management, sports nutrition, and cognitive support formulations. Featuring an integrated acetyl group and a hydrochloride carrier, this compound exhibits enhanced water solubility and stability, facilitating mitochondrial fatty acid transport while supporting central nervous system energy metabolism. Manufactured via precise chemical synthesis and multi-stage crystallization, this fine crystalline powder provides consistent batch-to-batch uniformity, minimal residual impurities, and controlled moisture absorption for industrial dietary supplement manufacturing.
Key Specifications
|
Parameter |
Specification Standard |
Test Method |
|
Assay (Dry Basis) |
98.5% - 101.0% |
Non-aqueous titration |
|
Specific Optical Rotation |
-27.0° to -29.0° |
Polarimetry (20°C, c=1, water) |
|
Water Content |
≤ 1.0% |
Karl Fischer |
|
pH Value (5% Solution) |
2.0 - 3.5 |
Potentiometry |
|
Heavy Metals |
Pb < 0.5 ppm, As < 0.1 ppm |
ICP-MS |
|
Microbial Limits |
< 1000 CFU/g (Total Aerobic) |
Plate count |
Chemical & Functional Profile
Acetyl Group Delivery: Donates an active acetyl moiety utilized in acetylcholine synthesis and central nervous system energy metabolism.
Mitochondrial Transport: Acts as a direct carrier for long-chain fatty acids across the inner mitochondrial membrane for beta-oxidation.
Thermal Stability: Maintains structural integrity under standard processing temperatures utilized during capsule filling and powder blending.
Hygroscopic Behavior: Exhibits moderate moisture affinity, requiring controlled relative humidity environments during handling and storage.
Technical Focus & Processing Parameters
Particle Size Distribution (PSD): Controlled milling ensures 90% of particles pass through an 80-mesh sieve, preventing segregation in dry-blend formulations.
Residual Solvent Compliance: Analyzed via gas chromatography (GC) to verify compliance with organic solvent residue limits.
Chiral Purity: Enantiomerically pure L-isomer configuration confirmed via high-performance liquid chromatography (HPLC).
Flowability Parameters: Bulk density ranging from 0.40 g/ml to 0.60 g/ml, engineered for consistent volumetric dosing on industrial encapsulation machines.
Formulation & Application Considerations
Excipient Compatibility: Compatible with standard microcrystalline cellulose, magnesium stearate, and silica flow agents; avoid strong alkaline excipients that may trigger salt dissociation.
Moisture Management: Requires packaging in low-moisture barrier containers and operation in humidity-controlled production rooms (recommended relative humidity below 45%) due to hygroscopic properties.
Masking Strategies: Slightly acidic profile and characteristic taste require flavoring agents or acid-resistant capsule shells for oral delivery.
Synergistic Blends: Integrates cleanly with botanical extracts, amino acids, and lipotropic compounds in complex weight management formulations.
Target Applications
Weight Management Capsules: Formulated as a standalone or combination active ingredient for fat-loss supplement lines.
Pre-Workout Drink Mixes: Added to powdered beverage formulas targeting energy expenditure and mental focus during physical exertion.
Nootropic Powders: Utilized in cognitive enhancement formulations aiming to support neural energy metabolism.
Tableted Formulations: Processed into direct-compression tablets with appropriate binding agents and moisture-barrier excipients for controlled-release or standard dietary supplement delivery.
Quality Assurance & Control
Testing Protocols: Every production lot undergoes multi-point analytical verification using titration, spectroscopy, and chromatography.
Traceability Systems: Full batch records document raw material origins, reaction parameters, purification steps, and final packaging dates.
Impurities Screening: Comprehensive screening targets related substances, degradation products, and inorganic salt residues.
Reference Standards: Analytical methods validated against recognized pharmacopeial standards to ensure laboratory data reproducibility.
Storage Guidelines
Temperature Control: Store in a cool, dry environment maintained between 15°C and 25°C.
Moisture Protection: Keep containers hermetically sealed with desiccants inside to prevent moisture ingress and clumping.
Light Exposure: Shield from direct sunlight and ultraviolet radiation to preserve chemical stability.
Shelf Life: Stable for 36 months from the date of manufacture when stored under specified conditions in original unopened packaging.
Regulatory Compliance & Documentation
Analytical Validation: Complete Certificates of Analysis covering registration, pilot, and commercial batches.
Safety Documentation: Material Safety Data Sheets fully compliant with the latest GHS standards.
Technical Specifications: Detailed Product Specifications, Method of Analysis, and Route of Synthesis.
Regulatory Declarations: Official BSE/TSE-Free certificates, non-GMO declarations, and allergen statements.
Global Dossier Support: Active DMF and CEP coordination for regulated markets including US FDA, European EMA, and Japanese PMDA.
Packaging & Logistics
Primary Container: Food-grade low-density polyethylene (LDPE) inner bags sealed with tamper-evident security ties.
Secondary Container: Multi-layer fiber drums equipped with moisture barrier liners and integrated desiccants to protect contents during transit.
Standard Batch Sizes: Available in 25 kg net weight drum configurations, optimized for palletized ocean and air freight.
Transport Protection: Pallets wrapped in protective stretch film with humidity indicators included for international shipments.
Frequently Asked Questions
Q: What differentiates L-Carnitine Base from Acetyl-L-Carnitine Hydrochloride?
A: The hydrochloride salt form includes an acetyl group and a chloride molecule, significantly increasing water solubility and allowing the molecule to cross the blood-brain barrier for cognitive and metabolic support applications.
Q: How does hygroscopicity impact industrial powder blending?
A: The material absorbs ambient moisture rapidly if exposed to high humidity. Production facilities must maintain relative humidity below 45% during powder handling and blending operations.
Q: What analytical method determines assay purity?
A: Assay is determined via non-aqueous titration using perchloric acid volumetric solution in accordance with established pharmacopeial testing procedures.
Q: Is the product suitable for direct compression tableting?
A: Yes, provided the formulation includes appropriate binding agents and moisture-barrier excipients to accommodate the physical properties of the hydrochloride salt.
Q: What documentation accompanies commercial orders?
A: Each shipment includes a detailed Certificate of Analysis, packing list, material safety data sheet (SDS), and lot-specific compliance verification documents.
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