Alpha-Lipoic Acid Sodium is a high-purity, highly water-soluble sodium salt of alpha-lipoic acid engineered for advanced dietary supplement formulations, delivering enhanced aqueous solubility and superior physiological absorption compared to standard free acid variants.
Key Specifications
|
Parameter |
Specification Standard |
|
Assay (HPLC) |
>= 99.0% |
|
pH Value |
7.0 to 9.5 (1% aqueous solution) |
|
Loss on Drying |
<= 0.5% |
|
Heavy Metals |
< 10 ppm (as Pb) |
|
Residual Solvents |
ICH Q3C Compliant |
Chemical & Functional Profile
Aqueous Solubility: Dissolves rapidly in water exceeding 50 mg/mL at 20 degrees Celsius, eliminating dispersion barriers inherent in standard crystalline forms.
Thermal Stability: Salt configuration provides enhanced stability against thermal stress during high-speed industrial blending operations.
Absorption Kinetics: Rapid dissolution profile facilitates faster gastric emptying and elevated systemic bioavailability in clinical profiling.
Product-Specific Technical Focus
Moisture Control: Processed via controlled vacuum drying to inhibit premature hydrolysis and caking tendencies during extended storage cycles.
Particle Size Distribution (PSD): Milled to 90% passing through an 80-mesh screen, guaranteeing uniform powder blend homogeneity in direct compression systems.
Chiral Parameters: Controlled optical rotation designed to meet strict metabolic efficacy and stereospecific purity requirements.
Formulation & Application Parameters
Excipient Compatibility: Fully compatible with standard direct compression binders including microcrystalline cellulose and anhydrous lactose alongside alkaline stabilizers.
Hygroscopic Management: Requires processing environments maintained below 45% relative humidity during capsule filling and tablet punching phases.
Liquid Delivery: Suitable for liquid-fill hard capsules and functional drop preparations without phase separation or precipitation issues.
Target Applications
Weight Management Supplements: Integrated into metabolic support formulations targeting cellular energy expenditure and glucose utilization pathways.
Antioxidant Formulations: Utilized in systemic anti-aging and mitochondrial health proprietary capsules.
Sports Nutrition: Added to advanced post-workout recovery mixes designed for oxidative stress reduction.
Quality Control & Analytical Standards
Assay Verification: Quantified via high-performance liquid chromatography coupled with diode-array detection.
Trace Elemental Screening: Evaluated via inductively coupled plasma mass spectrometry to ensure heavy metals remain well below pharmacopeial thresholds.
Microbiological Safety: Total aerobic microbial count maintained below 1000 CFU/g with complete absence of specified pathogens per pharmacopeial monographs.
Storage & Handling Guidelines
Container Configuration: Sealed in dual-layer food-grade polyethylene bags housed inside rigid fiber drums or aluminum foil moisture-barrier bags.
Environmental Controls: Store below 25 degrees Celsius in a dark, dry environment with containers tightly closed to prevent atmospheric moisture uptake.
Shelf Life Stability: Validated for 24 months from the manufacturing date under specified unopened storage parameters.
Documentation & Compliance Support
Comprehensive Dossiers: Supplied with full analytical batches including registration, pilot, and commercial validation records.
Safety & Specifications: Includes GHS-compliant MSDS, product specifications, method of analysis, and route of synthesis documentation.
Regulatory Declarations: Fully verified statements covering BSE/TSE-free status, non-GMO compliance, and allergen management.
DMF & CEP Support: Backed by partner manufacturers maintaining active regulatory files across major international health authorities.
Packaging & Logistics
Standard Bulk Packaging: 25 kg net weight per fiber drum featuring dual low-density polyethylene inner liners; customized packaging available upon request.
Transport Classification: Non-hazardous chemical classification suitable for standard dry cargo freight protected from direct sunlight and moisture exposure.
Sample Program: Evaluation quantities ranging from 100 g to 1 kg available immediately for laboratory R&D and analytical method validation.
Frequently Asked Questions
Q: What is the primary advantage of the sodium salt over standard alpha-lipoic acid?
A: The sodium salt provides significantly higher water solubility and a neutral-to-alkaline pH profile, resolving formulation hurdles in liquid systems and enhancing absorption rates.
Q: Does this material require cold chain shipping?
A: No. The product is thermally stable under ambient shipping conditions (15 degrees Celsius to 30 degrees Celsius), though extreme heat exposure should be avoided.
Q: What is the typical lead time for commercial orders?
A: Standard bulk orders ship within 10 to 15 business days following order confirmation and quality release verification.
Q: Are analytical methods validated for transfer to client laboratories?
A: Yes. Internal HPLC test methods and impurity profiles are fully documented and available for analytical method transfer upon request.
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