Thioctic Acid (CAS No.: 62-46-4) - Natural Antioxidant & Coenzyme for Metabolic Support
As a professional supplier of pharmaceutical-grade, nutraceutical-grade, and cosmetic-grade active ingredients, we provide high-purity Thioctic Acid (also known as Alpha-Lipoic Acid, ALA) that strictly complies with global standards (USP, EP, BP, FCC). A naturally occurring organosulfur compound, it acts as both a potent antioxidant and a critical coenzyme in cellular energy metabolism. Its unique ability to scavenge free radicals in both water-soluble and fat-soluble environments, plus its role in regenerating other antioxidants (e.g., vitamin C, vitamin E), makes it widely used in human medicine (for metabolic disorders), nutraceuticals (for antioxidant support), and cosmetics (for anti-aging formulations).
Product Basic Information
| Item | Details |
|---|---|
| Product Name | Thioctic Acid (Alpha-Lipoic Acid, ALA) |
| CAS No. | 62-46-4 |
| Synonyms | 5-(1,2-Dithiolan-3-yl)pentanoic acid; α-Lipoic acid; Lipoic acid |
| Molecular Formula | C₈H₁₄O₂S₂ |
| Molecular Weight | 206.32 |
| Appearance | Yellow to pale yellow crystalline powder; Odorless or with a slight characteristic sulfur-like odor |
| Specification | - Pharmaceutical Grade: Purity ≥99.0% (HPLC); Assay 98.0%–102.0%; Melting point 60–62°C; Loss on drying ≤0.5%; Heavy metals (Pb≤5ppm, Hg≤1ppm, Cd≤1ppm); Residual solvents (ethanol ≤500ppm, acetone ≤500ppm)- Nutraceutical Grade: Purity ≥98.0% (HPLC); Assay 97.0%–103.0%; Heavy metals ≤10ppm- Cosmetic Grade: Purity ≥97.0% (HPLC); Heavy metals ≤20ppm |
| Melting Point | 60–62°C |
| Solubility | Slightly soluble in water (≈1 g/L at 25°C); Soluble in ethanol (≈200 g/L), methanol, chloroform, and vegetable oils; Insoluble in hexane |
| Storage Conditions | Store in a cool (15–25°C), dry, light-protected container; Sealed to prevent oxidation (sulfur groups are air-sensitive) and moisture absorption; Avoid contact with strong oxidizing agents; Shelf life: 36 months for pharmaceutical grade, 24 months for nutraceutical/cosmetic grades |
Core Functions & Mechanism of Action
62-46-4 exerts dual key roles-coenzyme activity in energy metabolism and antioxidant activity in free radical scavenging-making it a versatile bioactive compound:
1. Coenzyme in Cellular Energy Metabolism
Thioctic Acid 62-46-4 is an essential cofactor for the pyruvate dehydrogenase complex (PDHC) and α-ketoglutarate dehydrogenase complex-two critical enzymes in the mitochondria (cellular "powerhouses"):
These complexes convert pyruvate (from glucose breakdown) and α-ketoglutarate (from the Krebs cycle) into acetyl-CoA and succinyl-CoA, respectively.
This process is vital for generating adenosine triphosphate (ATP), the primary energy currency of cells.
In metabolic disorders (e.g., diabetic neuropathy), 62-46-4 helps restore mitochondrial function, improving energy production in damaged cells.
2. Potent Antioxidant Activity
Unlike most antioxidants (which are either water-soluble or fat-soluble), Thioctic Acid 62-46-4 is amphiphilic-it works in both cellular membranes (fat-soluble environment) and cytoplasm (water-soluble environment):
Free Radical Scavenging: Neutralizes reactive oxygen species (ROS, e.g., superoxide, hydroxyl radicals) and reactive nitrogen species (RNS, e.g., nitric oxide), reducing oxidative stress.
Antioxidant Regeneration: Recycles depleted antioxidants like vitamin C, vitamin E, glutathione, and coenzyme Q10 back to their active forms, amplifying the body's natural antioxidant defense.
Metal Chelation: Binds to toxic heavy metals (e.g., lead, mercury, copper), preventing them from generating free radicals and facilitating their excretion.
Core Applications
cas 62-46-4's multi-functional properties make it suitable for pharmaceutical, nutraceutical, and cosmetic industries:
1. Pharmaceutical Field
Primarily used for treating metabolic and oxidative stress-related disorders:
1.1 Diabetic Neuropathy
The most well-established clinical use-cas 62-46-4 improves nerve function and reduces symptoms (pain, numbness, tingling) in patients with diabetic peripheral neuropathy:
IV Administration: 600 mg once daily for 3 weeks (induction phase), followed by oral maintenance (600 mg once daily) for 4–6 months.
Mechanism: Reduces oxidative stress in nerve cells, improves microcirculation, and restores nerve conduction velocity.
1.2 Liver Disorders
Used as an adjuvant therapy for alcoholic liver disease and non-alcoholic fatty liver disease (NAFLD):
Oral dose: 600–1200 mg daily for 3–6 months.
Mechanism: Scavenges free radicals in liver cells, reduces lipid peroxidation, and supports liver detoxification pathways.
1.3 Other Metabolic Conditions
Insulin Resistance: May improve insulin sensitivity by reducing oxidative stress in pancreatic beta cells (investigational use, dose: 600–1200 mg daily).
Age-Related Cognitive Decline: Adjuvant use to reduce oxidative stress in the brain (clinical trials ongoing, dose: 600–1200 mg daily).
2. Nutraceutical Field
Widely used in dietary supplements for antioxidant support and metabolic health:
Antioxidant Formulas: Combined with vitamins C/E, glutathione, or coenzyme Q10 to enhance free radical scavenging (daily dose: 100–600 mg).
Blood Sugar Support: Added to supplements for pre-diabetic or diabetic individuals to support insulin function (daily dose: 300–600 mg).
Anti-Aging Supplements: Marketed for cellular protection against age-related oxidative damage (daily dose: 100–300 mg).
3. Cosmetic Field
Incorporated into skincare products for anti-aging and brightening effects:
Anti-Aging Serums/Creams: Reduces oxidative stress in skin cells, minimizes fine lines and wrinkles, and protects against UV-induced damage (typical concentration: 0.5%–2%).
Skin Brightening Products: Inhibits melanin production by chelating copper (a cofactor for tyrosinase, the key enzyme in melanin synthesis), reducing dark spots and hyperpigmentation (concentration: 1%–3%).
Antioxidant Primers: Forms a protective layer on the skin, neutralizing free radicals from pollution and environmental stressors.
Quality & Safety Assurance
As a multi-industry ingredient, Thioctic Acid requires strict quality control tailored to its application:
1. Manufacturing & Purity Control
Synthesis: Produced via chemical synthesis (e.g., condensation of 6,8-dichloro-octanoic acid with sodium sulfide) or microbial fermentation (for natural-source ALA). The process ensures:
High optical purity (for pharmaceutical use, the natural R-enantiomer is preferred, though racemic mixtures are used in nutraceuticals/cosmetics);
Minimal impurities (e.g., disulfide byproducts) ≤0.5% (pharmaceutical grade).
GMP Compliance: Pharmaceutical-grade Thioctic Acid is manufactured in Grade D cleanrooms (per ICH Q7 guidelines); nutraceutical/cosmetic grades comply with GMP for food/cosmetics.
2. Comprehensive Testing Protocol
| Test Item | Method | Acceptance Criterion |
|---|---|---|
| Purity & Assay | HPLC (C18 column, 210 nm detection) | Pharmaceutical grade: ≥99.0% purity; Nutraceutical grade: ≥98.0% purity |
| Optical Purity (Pharmaceutical Grade) | Chiral HPLC (polysaccharide column) | R-enantiomer ≥98.0% (natural form) |
| Related Substances | HPLC (gradient elution) | Single impurity ≤0.2%; Total impurities ≤0.5% (pharmaceutical grade) |
| Heavy Metals | ICP-MS (Inductively Coupled Plasma-Mass Spectrometry) | Pharmaceutical grade: Pb≤5ppm; Nutraceutical grade: ≤10ppm |
| Residual Solvents | GC (headspace sampling, FID detector) | Class 2 solvents ≤500ppm; Class 1 solvents not detected |
| Melting Point | Capillary tube method | 60–62°C (no decomposition) |
3. Safety Reminders
Human Use (Oral/IV):
Contraindications: Hypersensitivity to Thioctic Acid or sulfur-containing compounds; pregnancy/lactation (limited safety data-use under medical supervision).
Adverse Effects: Rare and mild: nausea, diarrhea, skin rash (oral); injection site pain (IV). High doses (>1200 mg/day) may cause hypoglycemia in diabetic patients (monitor blood glucose).
Cosmetic Use:
Generally safe for topical application; patch testing recommended for sensitive skin (may cause mild irritation in 1%–2% of users).
Cooperation & Contact
We supply Thioctic Acid in grades and forms tailored to different industries:
Pharmaceutical Grade: Fine powder (1kg–100kg per order, amber glass vials or aluminum foil bags) for tablets, capsules, and IV formulations.
Nutraceutical Grade: Powder or microencapsulated granules (10kg–500kg per order) for dietary supplements (improves stability in formulations).
Cosmetic Grade: Powder or oil-soluble solutions (5kg–200kg per order) for skincare products.
Value-added services include:
Providing DMF (Drug Master File) for pharmaceutical-grade products to support EU/US/Asia registration.
Customized formulations (e.g., microencapsulation for nutraceuticals, oil-soluble blends for cosmetics) to enhance stability and bioavailability.
Regulatory support for nutraceuticals (compliance with FDA GRAS, EU Novel Food regulations) and cosmetics (INCI labeling, safety data sheets/SDS).
If you are a pharmaceutical manufacturer, nutraceutical brand, or cosmetic formulator, please contact us for detailed cooperation:
Contact Information:
Email: sales@huarongpharma.com
Phone/WhatsApp: +86 13751168070
We adhere to the principles of "multi-grade quality, application versatility, and safety compliance" and look forward to partnering with global pharmaceutical, nutraceutical, and cosmetic industries!
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