Ingrediente especial

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

Ácido alfa lipoico en polvo

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

Nº CAS 1077-28-7
Fórmula molecular C8H14O2S2
Peso molecular 206,33 g/mol
Apariencia 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
Cantidad 380 kg
Packing Size 25 kg / Drum
Ensayo 100.1%
Tamaño de las partículas 100% through 40 mesh

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

Technical Data

Alpha Lipoic Acid Specification

Test Item Especificación Batch Result Analysis Method
Identity & Physical Properties
Apariencia Slightly yellow crystal powder Cumple con Organoleptic
Identification A Retention time of the major peak corresponds to the standard solution Cumple con USP <621>
Identification B IR spectrum compares qualitatively with the standard Cumple con USP <197>
Melting point 60–62°C 60–62°C USP <741>
Pérdida por secado 0.2% max 0.05% USP <731>
Residuos de ignición 0.1% max 0.08% USP <281>
Rotación específica -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
Disolventes residuales
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
Tamaño de las partículas 100% through 40 mesh Cumple con USP <786>
Metales pesados 10 ppm max <10 ppm USP <231>
Cadmio 1 ppm max <0.005 ppm USP <233>
Arsénico 1 ppm max <0.01 ppm USP <233>
Plomo 3 ppm max <0.02 ppm USP <233>
Mercurio 0.1 ppm max <0.005 ppm USP <233>
Assay & Microbiological Tests
Ensayo 99.0%–101.0% 100.1% USP <621>
Total aerobic microbial count 1000 CFU/g max <100 UFC/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>

Formulación

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.

Cápsulas Particle size and powder handling should be considered alongside the filling process and blend composition.
Tabletas Flow, compaction and processing temperature should be considered during development.
Mezclas en polvo 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.

Tamaño de las partículas 100% through 40 mesh · USP <786>
Melting point 60–62°C · USP <741>

Aplicaciones

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.

01

Cápsulas

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

02

Tabletas

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

03

Mezclas en polvo

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

04

Gummies & Chewables

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

Calidad

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
Documentación Certificate of Analysis available for product review
Sample Sample requests can be discussed before a commercial order

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