Specialty Ingredient

Alpha Lipoic Acid Powder Manufacturer & Bulk Supplier

Alpha Lipoic Acid powder with 99.0%–101.0% assay specification, 40-mesh particle size and a documented reference batch tested using USP methods.

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Product Information

Alpha Lipoic Acid Powder

Alpha Lipoic Acid is a sulfur-containing compound also known as Thioctic Acid. The supplied material is a slightly yellow crystalline powder.

CAS No. 1077-28-7

Molecular Formula C8H14O2S2

Molecular Weight 206.33 g/mol

Appearance Slightly yellow crystal powder

Certificate of Analysis

Reference Batch

The following batch information is taken directly from the supplied Certificate of Analysis dated the supplied certificate.

Batch No. C392505811

Quantity 380 kg

Packing Size 25 kg / Drum

Assay 100.1%

Particle Size 100% through 40 mesh

The certificate conclusion states: “The product complies with USP 2024.”

Technical Data

Alpha Lipoic Acid Specification

Test Item	Specification	Batch Result	Analysis Method
Identity & Physical Properties
Appearance	Slightly yellow crystal powder	Conforms	Organoleptic
Identification A	Retention time of the major peak corresponds to the standard solution	Conforms	USP <621>
Identification B	IR spectrum compares qualitatively with the standard	Conforms	USP <197>
Melting point	60–62°C	60–62°C	USP <741>
Loss on drying	0.2% max	0.05%	USP <731>
Residue on ignition	0.1% max	0.08%	USP <281>
Specific rotation	-1.0° to +1.0°	0°	USP <781>
Related Substances
Single impurity	0.10% max	0.01%	USP <621>
Total impurities	2.0% max	0.02%	USP <621>
Limit of polymer content	2.0% max	<2.0%	TLC
Residual Solvents
Cyclohexane	3880 ppm max	1796 ppm	USP <467>
Ethyl acetate	500 ppm max	105 ppm	USP <467>
Toluene	20 ppm max	6 ppm	USP <467>
Particle Size & Elemental Limits
Particle size	100% through 40 mesh	Conforms	USP <786>
Heavy metals	10 ppm max	<10 ppm	USP <231>
Cadmium	1 ppm max	<0.005 ppm	USP <233>
Arsenic	1 ppm max	<0.01 ppm	USP <233>
Lead	3 ppm max	<0.02 ppm	USP <233>
Mercury	0.1 ppm max	<0.005 ppm	USP <233>
Assay & Microbiological Tests
Assay	99.0%–101.0%	100.1%	USP <621>
Total aerobic microbial count	1000 CFU/g max	<100 CFU/g	USP <61>
Yeast & mold	100 CFU/g max	<10 CFU/g	USP <61>
E. coli	Absence/g	Not Detectable	USP <62>
Salmonella	Absence/g	Not Detectable	USP <62>
Staphylococcus aureus	Absence/g	Not Detectable	USP <62>

Formulation

Working with Alpha Lipoic Acid Powder

The physical properties of Alpha Lipoic Acid matter when the ingredient moves from raw material into a finished dosage form.

Powder Characteristics

This reference batch is a crystalline powder with 100% of the material passing through 40 mesh. The melting point is 60–62°C. These properties are relevant when evaluating powder handling and processing conditions.

Capsules Particle size and powder handling should be considered alongside the filling process and blend composition.

Tablets Flow, compaction and processing temperature should be considered during development.

Powder Blends Particle distribution and blend uniformity should be checked in the finished system.

Gummies & Chewables Formulation development should account for heat exposure and the behavior of the finished matrix.

Reference Physical Data

The supplied COA provides two useful physical parameters for formulation work.

Particle size 100% through 40 mesh · USP <786>

Melting point 60–62°C · USP <741>

Applications

Alpha Lipoic Acid Powder for Supplement Formulas

The powder can be considered for common supplement formats where the product specification and processing conditions are appropriate.

Capsules

For capsule formulas using a crystalline active ingredient in a defined powder blend.

Tablets

For tablet development where powder handling and processing conditions are suitable.

Powder Blends

For dry formulations where particle characteristics and blend uniformity meet the finished-product requirements.

Gummies & Chewables

For formulations where heat exposure and finished-product characteristics can be controlled.

Quality

Quality Data from the Reference Batch

The supplied COA covers identity, assay, related substances, residual solvents, particle size, elemental limits and microbiological testing.

Identity & Purity

The batch was evaluated for chromatographic and IR identification, assay, related substances, melting point and physical quality.

Assay: 100.1%
Single impurity: 0.01%
Total impurities: 0.02%
Loss on drying: 0.05%
Residue on ignition: 0.08%

Contaminants & Microbiology

The certificate also records elemental limits, residual solvent results and microbiological results for the batch.

Lead: <0.02 ppm
Arsenic: <0.01 ppm
Cadmium: <0.005 ppm
Mercury: <0.005 ppm
Salmonella: Not Detectable

Supply

Alpha Lipoic Acid in 25 kg Drum Packaging

The supplied reference batch was packed at 25 kg per drum. Quantity, packaging and product documentation can be discussed according to the material requirement.

Reference packing 25 kg / drum

Reference batch quantity 380 kg

Documentation Certificate of Analysis available for product review

Sample Sample requests can be discussed before a commercial order

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