Alpha Lipoic Acid

Product Overview

This is a premium-grade R-Alpha Lipoic Acid (R-ALA), meticulously synthesized to achieve exceptional isomeric purity and overall assay. Unlike standard, cost-driven racemic (50/50) Alpha Lipoic Acid, this material is composed of 98.27% R-Lipoic Acid. This is the biologically active enantiomer, the form naturally found in the body and recognized as a critical cofactor in mitochondrial energy metabolism.

With a total assay verified at 99.91% by HPLC, this yellow crystalline powder is the definitive choice for formulators developing high-potency dietary supplements and advanced cosmetic applications. It delivers the superior bioavailability and potency of the R-isomer while maintaining excellent processability and a competitive cost-per-active-unit.

Our advanced synthesis and purification process is engineered to minimize impurities and residual solvents. The resulting specification, as evidenced by our typical COA, shows ultra-low residual Toluene (0.00047%) and negligible heavy metal content, delivering unparalleled quality and regulatory confidence directly from the source.

Key Advantages:

• High Bioactive Form: Features 98.27% R-Isomer (enantiomeric) purity for maximum biological relevance.
• Exceptional Total Purity: 99.91% total ALA assay verified by HPLC, with total impurities at only 0.09%.
• Superior Safety Profile: Verified ultra-low residual solvents, with Toluene levels 189 times lower than the ICH limit.
• Isomeric Verification: R-form physically confirmed via Specific Rotation (typical result: +117°).
• Cost-Effective Potency: Provides a more potent, biologically active ingredient than racemic ALA, optimizing formulation cost-effectiveness.
• Direct Manufacturer Supply: Ensures full traceability, batch-to-batch consistency, and a reliable supply chain direct from our factory.

Key Technical Parameters (Based on Typical COA)

This specification table details the rigorous quality standards our R-Alpha Lipoic Acid consistently meets. The “Results” column reflects typical batch data from the provided COA, demonstrating consistent compliance that far exceeds the required standards.

Detection, Quality & Manufacturing Excellence

Quality is not just a specification; it is validated by transparent methodology and robust process control. We provide this data to empower your technical and regulatory teams.

Advanced Isomeric & Solvent Testing

The critical differentiator of R-ALA lies in its isomeric purity, which cannot be determined by standard HPLC.

• Isomer Analysis (Chiral HPLC): We employ high-resolution Chiral HPLC methods (chiral column chromatography) to precisely separate and quantify the R-Lipoic Acid (98.27%) from the inactive L-Lipoic Acid (1.72%).
• Specific Rotation: The positive specific rotation (dextrorotatory) of +117° serves as a crucial physical confirmation of the R-enantiomer’s predominance, cross-validating the chiral assay.
• Residual Solvents (GC-HS): We utilize Headspace Gas Chromatography (GC-HS) to detect volatile solvents down to the part-per-million (ppm) level. Our demonstrated result for Toluene (an ICH Class 2 solvent) is 0.00047% (or 4.7 ppm). This is 189 times lower than the accepted ICH Q3C limit of 0.089% (890 ppm), validating the exceptional safety and refinement of our manufacturing process.

GMP Manufacturing & Traceability

As the primary manufacturer and exporter of this high-purity ingredient, we provide complete supply chain transparency. Our facilities operate under strict GMP and ISO guidelines, ensuring robust quality control, superior batch-to-batch consistency, and full traceability for your documentation.

Available Documents for Your Compliance Needs:

• Certificate of Analysis (COA)
• Material Safety Data Sheet (MSDS)
• Allergen Statement
• Non-GMO Statement
• Kosher & Halal Certificates
• Manufacturing Flow Chart

Applications & Formulation Guidance

The high R-isomer content of this product makes it a potent and efficient ingredient for formulators seeking to leverage the “universal antioxidant” properties of Alpha Lipoic Acid.

Dietary Supplements

R-ALA is a versatile antioxidant, functioning in both water- and fat-soluble environments. Its high-bioavailability R-form is a premium component for:

• “Healthy Aging” Formulations: As a cornerstone antioxidant for cellular health.
• Glucose Metabolism Support: For supplements aimed at supporting healthy blood sugar levels.
• Nerve Health Support: A common ingredient in formulations for nerve comfort and function.
• Dosage Forms: The yellow crystalline powder provides good flowability for encapsulation (two-piece hard shells) and can be used in direct compression (tablets), though R-ALA’s physical characteristics may require specific excipients for optimal tableting performance.
• Typical Inclusion: 50 mg – 200 mg per serving.

Advanced Skincare & Cosmetics

Topically, R-ALA is a powerful antioxidant used to protect the skin barrier from oxidative stress and improve the appearance of skin tone and texture.

• Applications: High-potency serums, protective day creams, and “anti-aging” lotions.
• Formulation Note: R-Alpha Lipoic Acid is sensitive to heat and light. In emulsions, we recommend incorporating it during the cool-down phase (< 40℃). It performs best in stable emulsion or anhydrous (water-free) bases. Ensure packaging is opaque to protect from light.
• Typical Inclusion: 0.1% – 1.0%.

Stability, Storage & Handling

R-Alpha Lipoic Acid (CAS 1200-22-2) is sensitive to high temperatures, light, and polymerization. This is a known characteristic of the active R-isomer. To ensure the 24-month shelf life, strict adherence to storage protocols is essential.

• Storage: Store in original, unopened, airtight containers in a cool, dry, dark place. Refrigeration (recommended 2-8℃) is required for optimal long-term stability.
• Handling: Once opened, minimize exposure to air and moisture. Blanketing the headspace of partially used containers with an inert gas (e.g., Nitrogen or Argon) is highly recommended to prevent oxidation and polymerization.
• Shelf Life: 24 months from the date of manufacture when stored correctly.

Safety & Compliance

This ingredient is manufactured to meet or exceed major international regulatory standards for dietary supplements and cosmetics.

• Heavy Metals: Complies with strict limits for Pb, As, Hg, and Cd, as verified by ICP-MS.
• Microbiological: Free from pathogenic bacteria (E.coli, Salmonella) and maintains low total microbial counts, ensuring safety for nutritional use.
• Solvents: Complies with USP <467> and ICH Q3C guidelines for residual solvents.

Frequently Asked Questions (FAQ)

Q: What is the primary difference between your R-ALA (98.27% R-Isomer) and standard 50/50 racemic ALA?

A: Standard racemic ALA is a 50/50 mixture of R-Lipoic Acid and L-Lipoic Acid. Our product contains 98.27% of the R-isomer, which is the only form the human body endogenously produces and recognizes as a cofactor. This provides significantly higher biological activity and potency per milligram, making it a more efficient and effective ingredient for your formulation.

Q: Your COA shows 99.91% Assay but 98.27% R-Lipoic Acid. Can you explain this?

A: This is an excellent technical question. The “Assay (99.91%)” measures the total Alpha Lipoic Acid (both R and L isomers) by a standard HPLC method. The “Isomer (98.27%)” test uses a specialized Chiral HPLC method to determine the ratio of those isomers. This COA demonstrates that of the 99.91% total ALA, 98.27% is the desired R-form and only 1.72% is the L-form.

Q: The COA lists Toluene. Is this compliant with USP <467> or EU regulations? A: Yes, it is fully compliant. Toluene is an ICH Class 2 solvent. The specification (NMT 0.089% or 890 ppm) is the accepted international limit. Our typical batch result of 0.00047% (or 4.7 ppm) is 189 times lower than this limit, demonstrating an exceptionally clean and safe product that easily meets all global standards, including those for USP <467>.

Q: How stable is this R-ALA powder compared to Na-R-ALA?

A: This is R-Alpha Lipoic Acid free acid, which is inherently less stable than its sodium salt (Na-R-ALA), particularly in heat and moisture. However, this form is often preferred for specific formulations (e.g., non-hygroscopic, water-free, or specific pH) and labeling (“sodium-free”). Stability is excellent when our storage protocols (refrigerated, dark, inert gas) are followed.

Q: Are you the direct manufacturer of this R-ALA?

A: Yes, we are the original manufacturer and global exporter of this high-purity R-Alpha Lipoic Acid. We manage the entire synthesis and purification process, ensuring full traceability and batch consistency directly from our factory to your facility.

Q: What is the typical MOQ and HS Code for bulk international orders?

A: Our standard MOQ for this product is 25kg, packed in export-grade drums. The HS Code for Alpha Lipoic Acid is typically 2934.99. Please contact our sales team for a formal quote based on your volume and destination.