L-Carnitine Fumarate is an odorless, white crystalline powder formed by bonding L-carnitine with fumaric acid in a precise stoichiometric ratio, functioning as a vital metabolic intermediate that facilitates long-chain fatty acid transport across the mitochondrial inner membrane while delivering fumarate directly to the Krebs cycle for enhanced cellular ATP generation.
Key Specifications
|
Specification Item |
Target Parameter / Limit |
Test Method |
|
Assay (Dry Basis) |
98.0% – 102.0% |
Titration |
|
L-Carnitine Content |
68.0% – 72.0% |
Anhydrous Basis |
|
Specific Optical Rotation |
-16.5° to -19.0° |
c=1, H2O |
|
Loss on Drying |
NMT 1.0% |
105°C, 3 hours |
|
Heavy Metals (as Pb) |
NMT 10 ppm |
ICP-MS |
|
Arsenic (As) |
NMT 1.0 ppm |
ICP-MS |
|
Lead (Pb) |
NMT 0.5 ppm |
ICP-MS |
|
Total Aerobic Microbial Count |
NMT 1000 CFU/g |
Pharmacopeial Assay |
|
Molds and Yeasts |
NMT 100 CFU/g |
Pharmacopeial Assay |
Chemical & Functional Profile
Stoichiometric Stability: Ionic bonding between zwitterionic L-carnitine and dicarboxylic fumarate yields a crystalline lattice that resists thermal degradation during spray drying and high-shear granulation.
Synergistic Energy Yield: Fumaric acid acts as an immediate TCA cycle intermediate, bypassing rate-limiting steps in cellular respiration to accelerate mitochondrial oxidative phosphorylation.
Moisture Resistance: Exhibits reduced moisture adsorption kinetics under ambient relative humidity, preventing bulk powder aggregation during capsule filling operations.
Technical & Manufacturing Focus
Crystallinity Control: Controlled crystallization parameters eliminate amorphous fractions, ensuring uniform particle size distribution for direct compression lines.
Low Bioburden Profile: Manufactured via automated closed-loop synthesis systems, maintaining microbial compliance without chemical fumigation.
Impurities Profile: Strict chromatographic separation protocols restrict related substances and chiral isomers below stringent pharmacological thresholds.
Formulation & Application Parameters
Excipient Compatibility: Demonstrates high chemical inertness when blended with microcrystalline cellulose, dicalcium phosphate, and magnesium stearate.
Tablet Compression: Retains structural hardness at low compression forces (8–12 kN), mitigating tablet capping risks in high-speed rotary presses.
PH Stability: Maintains stability in aqueous liquid delivery systems within an operating window of pH 4.5 to 7.0.
Typical Applications
Female Weight Management Capsules: Core active ingredient for targeted lipid oxidation and cellular energy support in daily thermogenic formulas.
Pre-Workout Powder Blends: Functional agent for reducing lactic acid accumulation and sustaining muscular output during endurance exercise.
Chewable Tablets: High-density raw material utilized for flavored oral delivery matrices without hygroscopic swelling.
Liquid Ampoules: Liquid-phase delivery systems requiring rapid dissolution and neutral organoleptic properties.
Quality Control & Testing
Chromatographic Purity: Quantified via High-Performance Liquid Chromatography (HPLC) equipped with refractive index detectors to isolate degradation products.
Trace Metal Screening: Inductively Coupled Plasma Mass Spectrometry (ICP-MS) verification maintaining heavy metals below strict safety thresholds.
Microbial Enumeration: Standard plate count, mold, yeast, and pathogen screening performed per pharmacopeial monographs.
Storage & Handling
Container Integrity: Store in double food-grade low-density polyethylene bags sealed inside rigid fiber drums.
Environmental Controls: Keep in a cool, dry, well-ventilated area away from direct sunlight, maintaining ambient temperatures below 25°C and relative humidity under 60%.
Shelf Life: 24 months from the date of manufacture when kept in original unopened packaging.
Documentation & Compliance Support
Analytical Certification: Complete Certificate of Analysis (CoA) provided for every production batch, detailing residual solvents and heavy metal assays.
Regulatory Dossiers: Comprehensive Material Safety Data Sheet (MSDS), non-GMO statements, and allergen-free declarations available upon request.
Traceability: Full forward and backward lot traceability linked to raw material procurement records and inline processing logs.
Packaging & Logistics
Primary Packaging: Double-layer food-grade polyethylene bag heat-sealed under nitrogen purge.
Secondary Packaging: Moisture-resistant cardboard fiber drum with tamper-evident locking ring.
Standard Net Weight: 25 kg per drum, with customized packaging configurations available for commercial scale orders.
Frequently Asked Questions
Q: What is the primary manufacturing advantage over L-Carnitine Tartrate?
A: L-carnitine fumarate features a significantly lower hygroscopic rate and higher thermal stability, making it superior for solid dosage tablet compression where moisture absorption causes caking.
Q: Does this product contain residual organic solvents?
A: All residual solvents are monitored via gas chromatography and maintained well below international pharmacopeia limits.
Q: What is the typical lead time for bulk commercial orders?
A: Standard production batches ship within 7 to 10 business days following order confirmation, supported by air or ocean freight logistics.
Q: Are samples provided for laboratory scale-up and testing?
A: Representative sample quantities are available for R&D evaluation and analytical verification accompanied by full analytical documentation.
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