Bio-Enhanced™ Na RALA
Bulk Powder

R-lipoic Acid sodium salt, sodium R-(+)-lipoate, Na-RALA: [176110-81-9]

Bio-Enhanced™ Na-RALA, a 70% active R-lipoic acid powder is stable, extremely low (<2.0 %) in insoluble polymer and offers an innovative solution for capsules, tablets and powdered drink mixes.

Bio-Enhanced™ Na-RALA contains 22.66 - 32.161 mg NaHCO3/Na2CO3 [sodium bicarbonate/sodium carbonate] = 16.99-22.52% and is water soluble.

Bio-Enhanced™ Na-RALA is significantly more bioavailable than R-lipoic acid (RLA).

1000mg (1gram) RLA reaches a maximum concentration (Cmax) of 1.1ug/ml in human plasma
100mg (0.1gram) Bio-Enhanced™ Na-RALA reaches a Cmax of 2.3ug/ml
On a weight basis Bio-Enhanced™ Na-RALA reaches a Cmax 21 times higher than RLA.

Although Bio-Enhanced™ Na-RALA may be suitable for multi-component formulations, the performance of this product in any new or experimental formula must determined by testing its stability with all of the ingredients. Acidic components may adversely affect the stability and shelf-life of Bio-Enhanced™ Na-RALA containing products.

Specifications

Appearance - Light yellow to off-white fine powder with 70% active R-lipoic acid
Solubility - 1 g dissolves in 50 ml water at room temperature; the solution should be clear
Specific Rotation - + 60° ~ +85°
Melting Point(BP) - 230° ~ 250° C (with decomposition beginning at (~210° C)
Heavy Metals - ≤ 5 ppm
Loss on Drying - ≤ 3.00 %
Assay (by HPLC - ≥ 70.00 % R-lipoic acid
Bulk density - .16 g/cc bulk, .23 g/ cc tap
Free flowing, heat stable up to 85° C and ready for blending with excipients.
Available from 1 kg to metric ton quantities.
The shelf life is a minimum of 3 years.
Bio-Enhanced™ NaRLA comes in 3 different grades 60-70%, 70-80%, >80%. Pricing is based on RLA content and subject to availability.

Particle Size

100% through a 20 mesh
58% retained on an 80 mesh
42% passing the 80 mesh

Stability

Na-RLA (USP assay for ALA=74% RLA initial) was heated to 100 deg C for 6 hours. The polymer content had increased by 6% using the same assay and standard; final assay =68%.

For comparison, 10g RLA was heated for 10 minutes at 100 deg C and was completely insoluble and polymerized.

Advantages

Increased stability - Bio-Enhanced™ Na-RALA requires no refrigeration and has a shelf life of at least 3 years without polymerization. Solid R-Lipoic Acid is prone to quickly polymerize upon exposure to heat, light, and moisture.
Increased Solubility - Cleanly soluble in water, whereas RLA is poorly soluble and K-RALA can only be dispersed because of the insoluble excipients.
No Solvent Residues - Due to the low melting point of the lipoic acid crystalline structure, there is a tendency for RLA to hold on to high amounts of cyclohexane, ethyl acetate or toluene.
High Bioavailability - max 21 times higher and AUC 3.3 times higher than RLA.

The additional processing necessary to make Bio-Enhanced™ Na-RALA removes the residual solvents.