Levocarnitine Hydrochloride

Levocarnitine Hydrochloride is a high-purity, synthetically derived L-isomer salt of carnitine engineered specifically for pharmaceutical, nutraceutical, and functional food oral dosage formulations. Acting as an essential cofactor in cellular energy metabolism, it facilitates the transmembrane transport of long-chain fatty acids into the mitochondrial matrix for beta-oxidation.

Manufactured under strict Current Good Manufacturing Practice (cGMP) guidelines, this white crystalline powder delivers exceptional aqueous solubility and thermal stability, serving as the premier raw material for targeted metabolic support, cellular energy production, and specialized weight management formulations.

Molecular Formula & Weight: C7H15NO3 HCl, formula weight of 197.66 g/mol, ensuring precise stoichiometric active calculations.

Hygroscopic Behavior: Exhibits controlled moisture attraction, requiring strict environmental relative humidity monitoring during industrial processing.

Solubility Profile: Rapidly soluble in water (> 1 g/mL at 20 deg C) and methanol, facilitating fast-dissolution matrices.

Aqueous Stability: Maintains structural integrity across pH 3.0 to 5.5, supporting stable integration into acidic liquid syrups and oral drops.

Chiral Resolution: Synthesized via stereospecific pathways to guarantee zero contamination from inactive D-carnitine isomers.

Trace Impurity Control: Continuously monitored via High-Performance Liquid Chromatography (HPLC) to keep process-related organics below 0.05%.

Thermal Threshold: Maintains full stability during standard industrial granulation and drying procedures without thermal decarboxylation.
 

Excipient Compatibility: Demonstrates minimal chemical reactivity with microcrystalline cellulose and magnesium stearate during direct powder compression.

Granulation Guidelines: Fluid-bed processing requires inlet air temperatures maintained below 55 deg C with neutral pH binder solutions.

Tableting Performance: Fully compatible with standard punch tooling, achieving tablet tensile strengths exceeding 1.5 MPa at compression forces of 8 to 12 kN.

Weight Management: Formulated into specialized metabolic activation capsules targeting cellular lipid oxidation.

Liquid Concentrates: Integrated into high-concentration aqueous drop formulations requiring complete clarity and stability.

Oral Pharmaceuticals: Utilized in prescription-grade metabolic disorder therapies requiring strict physiological dosing.

Sports Nutrition: Combined with synergistic amino acid matrices in compressed effervescent tablets for post-workout recovery products.

Batch Verification: Every production lot undergoes rigorous testing covering assay, residual moisture, and heavy metal profiles.

Chromatographic Purity: Assessed via validated HPLC methods equipped with diode-array detection to guarantee molecular uniformity.

Microbial Limits: Total aerobic microbial count maintained below 1000 CFU/g, with a guaranteed complete absence of pathogenic bacteria.

Supply Traceability: Full electronic traceability covering starting reactants, intermediate catalysts, and purification solvents.

Temperature Control: Store in a controlled environment between 15 and 25 deg C, protected from direct sunlight.

Humidity Management: Keep containers hermetically sealed under relative humidity conditions below 60%.

Shelf Life: Retains full specification compliance for 36 months in original unopened packaging.

Quarantine Separation: Must be kept strictly isolated from strong oxidizing agents and alkaline chemical substances.

Comprehensive Analytical Dossiers: Complete packages including registration, pilot, and commercial validation batch Certificates of Analysis, alongside fully compliant GHS Safety Data Sheets.

Core Technical Specifications: Detailed product specs, standardized methods of analysis, and transparent routes of synthesis to support rigorous technical evaluation.

Global Regulatory Declarations: Verified formal statements confirming BSE/TSE-free status, non-GMO compliance, and complete allergen-free documentation.

Master File Coordination: Active support for Drug Master Files and Certificates of Suitability aligned with major regulatory bodies including the US FDA, European EMA, and Japanese PMDA.
 

Primary Container: Food-grade low-density polyethylene inner liner bags, heat-sealed under a filtered nitrogen blanket.

Secondary Protection: Heavy-duty fiber drums reinforced with tamper-evident locking rings; Net weight: 25 kg per unit.

Transport Conditions: Shipped via temperature-monitored, dry freight vehicles protected from extreme thermal cycling.

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