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As modern bio-pharmaceutical, food processing, and cosmetic formulation industries demand higher stereospecific purity and lower trace impurity profiles, Disodium L-Malate (CAS 676-00-6 / 138-83-5)—commonly referred to as L-Malate Sodium—has transitioned from a niche organic salt to a vital macro-component. Serving as a crucial metabolic intermediate within the Tricarboxylic Acid (TCA / Krebs) cycle, L-Malate Sodium provides distinct physiological and chemical advantages over racemic DL-malate mixtures. Global multinational corporations are increasingly shifting procurement strategies toward stereospecifically pure L-enantiomers to enhance drug bioavailability, eliminate toxic metabolic burdens, and achieve superior flavor-masking profiles in low-sodium formulations.
Gentolex operates at the vanguard of this industrial evolution. As an established OEM L-Malate Sodium Factory & Exporter, we leverage advanced biotransformation technology, continuous crystallization engineering, and cGMP-compliant downstream processing. Our state-of-the-art 250,000 square meter manufacturing infrastructure guarantees structural integrity, batch-to-batch consistency, and rigorous regulatory adherence for international procurement teams across North America, the European Union, the Asia-Pacific region, and emerging Latin American markets.
| Parameter / Specification | Pharmaceutical (Parenteral) Grade | Nutraceutical / Food Grade | Industrial / Tech Grade |
|---|---|---|---|
| Chemical Name | Disodium L-Malate / L-Hydroxybutanedioate Disodium Salt | ||
| CAS Registry Number | 676-00-6 (Anhydrous) / 138-83-5 (Hemihydrate/Trihydrate) | ||
| Assay (Dry Basis) | 99.0% - 101.0% | 98.5% - 100.5% | ≥ 98.0% |
| Enantiomeric Purity (Optical Rotation) | [α]D20 = -6.5° to -7.5° (ee > 99.5%) | [α]D20 = -6.2° to -7.5° | [α]D20 = -5.8° to -7.5° |
| Bacterial Endotoxins | < 0.05 EU/mg | N/A | N/A |
| Heavy Metals (as Pb) / Arsenic | ≤ 5 ppm / ≤ 1 ppm | ≤ 10 ppm / ≤ 2 ppm | ≤ 20 ppm |
| Solubility in Water (20°C) | Fully soluble (> 450 g/L), crystal clear | Fully soluble, clear solution | Soluble |
| Primary Industrial Application | Parenteral Nutrition, IV Electrolytes, API Buffer | Low-Sodium Salt Replacer, Flavor Buffer | Biomaterial Synthesis, Chelating Agent |
Our green bio-fermentation and enzymatic route guarantees absolute chiral selection, eliminating toxic by-products inherent to legacy petrochemical methods.
Utilizing immobilized fumarase enzymes derived from selected non-GMO microbial strains, we catalyze the hydration of fumaric acid directly into stereospecific L-malic acid, which is subsequently neutralized with ultra-pure sodium hydroxide under nitrogen protection to yield Disodium L-Malate.
Unlike chemical synthesis that produces racemic D/L mixtures (where D-malate lacks natural biological activity and can accumulate metabolically), our bio-route yields strictly the naturally occurring L-stereoisomer with enantiomeric excess (ee) exceeding 99.5% confirmed via HPLC chiral stationary phases.
For injectable medical applications, our proprietary multi-stage ultrafiltration and nanofiltration system removes pyrogens, bacterial endotoxins, and heavy metal contaminants down to parts-per-billion (ppb) levels, exceeding international USP/EP parenteral monographs.
Discover how global formulators integrate L-Malate Sodium across medical, dietary, and high-performance industrial sectors.
In total parenteral nutrition (TPN) and intravenous rehydration fluids, L-Malate Sodium acts as a superior organic anion buffer compared to lactate or acetate. It directly participates in hepatic mitochondrial ATP generation without increasing blood lactate levels, preventing metabolic acidosis in critically ill patients.
In the food and beverage industry, L-Malate Sodium delivers a distinctive smooth salty-sour taste profile. It exhibits strong synergistic effects with monosodium glutamate (MSG) and ribonucleotides, allowing food engineers to reduce overall sodium chloride (table salt) content by up to 35% without compromising sensory palatability.
As an Alpha Hydroxy Acid (AHA) derivative, L-Malate Sodium buffers facial formulations, maintaining optimum skin pH (4.5 - 5.5). It enhances intracellular moisture retention, stimulates collagen synthesis, and facilitates mild exfoliation in anti-aging cosmetic serums.
Gentolex’s goal is to create opportunities connecting the world with better services and guaranteed products. Up to date, Gentolex Group has been serving customers from more than 10 countries, specially, representatives are established in Mexico and South Africa.
Our main services focus on supplying peptides APIs and Custom Peptides, FDF license out, Technical Support & Consultation, Product Line and Lab Setup, Sourcing & Supply Chain Solutions.
With an overall factory construction area of 250,000 square meters under international standards, we offer flexible, scalable, and cost-effective solutions. Gentolex offers an extensive range of APIs and intermediates for development study and commercial application with cGMP standard from long-term collaborations. Full regulatory documentation and certificates are provided to customers worldwide.
Our operations comply with stringent global regulatory regimes, maintaining valid quality certifications to support seamless customs clearance and pharmaceutical validation.
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