Специализированный ингредиент
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.
Product Information
Альфа-липоевая кислота порошок
Alpha Lipoic Acid is a sulfur-containing compound also known as Thioctic Acid. The supplied material is a slightly yellow crystalline powder.
Certificate of Analysis
Reference Batch
The following batch information is taken directly from the supplied Certificate of Analysis dated the supplied certificate.
The certificate conclusion states: “The product complies with USP 2024.”
Technical Data
Alpha Lipoic Acid Specification
| Test Item | Технические характеристики | Batch Result | Analysis Method |
|---|---|---|---|
| Identity & Physical Properties | |||
| Внешний вид | Slightly yellow crystal powder | Соответствует | Organoleptic |
| Identification A | Retention time of the major peak corresponds to the standard solution | Соответствует | USP <621> |
| Identification B | IR spectrum compares qualitatively with the standard | Соответствует | USP <197> |
| Melting point | 60–62°C | 60–62°C | USP <741> |
| Потери при сушке | 0.2% max | 0.05% | USP <731> |
| Остаток при прокаливании | 0.1% max | 0.08% | USP <281> |
| Специфическое вращение | -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 |
| Остаточные растворители | |||
| 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 | |||
| Размер частиц | 100% through 40 mesh | Соответствует | USP <786> |
| Тяжелые металлы | 10 ppm max | <10 ppm | USP <231> |
| Кадмий | 1 ppm max | <0.005 ppm | USP <233> |
| Мышьяк | 1 ppm max | <0.01 ppm | USP <233> |
| Свинец | 3 ppm max | <0.02 ppm | USP <233> |
| Ртуть | 0.1 ppm max | <0.005 ppm | USP <233> |
| Assay & Microbiological Tests | |||
| Анализ | 99.0%–101.0% | 100.1% | USP <621> |
| Total aerobic microbial count | 1000 CFU/g max | <100 КОЕ/г | USP <61> |
| Yeast & mold | 100 CFU/g max | <10 CFU/g | USP <61> |
| кишечная палочка | Absence/g | Not Detectable | USP <62> |
| Сальмонелла | Absence/g | Not Detectable | USP <62> |
| Staphylococcus aureus | Absence/g | Not Detectable | USP <62> |
Формула
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.
Reference Physical Data
The supplied COA provides two useful physical parameters for formulation work.
Приложения
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.
Капсулы
For capsule formulas using a crystalline active ingredient in a defined powder blend.
Планшеты
For tablet development where powder handling and processing conditions are suitable.
Смеси порошков
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.
Качество
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.
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