المكونات المتخصصة
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
مسحوق حمض ألفا ليبويك أسيد ألفا ليبويك
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 | المواصفات | Batch Result | Analysis Method |
|---|---|---|---|
| Identity & Physical Properties | |||
| المظهر | Slightly yellow crystal powder | يتوافق مع | Organoleptic |
| Identification A | Retention time of the major peak corresponds to the standard solution | يتوافق مع | USP <621> |
| Identification B | IR spectrum compares qualitatively with the standard | يتوافق مع | USP <197> |
| Melting point | 60–62°C | 60–62°C | USP <741> |
| الخسارة عند التجفيف | 0.2% max | 0.05% | USP <731> |
| البقايا عند الاشتعال | 0.1% max | 0.08% | USP <281> |
| تناوب محدد | -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 | |||
| حجم الجسيمات | 100% through 40 mesh | يتوافق مع | USP <786> |
| المعادن الثقيلة | 10 ppm max | <10 ppm | USP <231> |
| الكادميوم | 1 ppm max | <0.005 ppm | USP <233> |
| الزرنيخ | 1 ppm max | <0.01 ppm | USP <233> |
| الرصاص | 3 ppm max | <0.02 ppm | USP <233> |
| الزئبق | 0.1 ppm max | <0.005 ppm | USP <233> |
| Assay & Microbiological Tests | |||
| التحليل | 99.0%–101.0% | 100.1% | USP <621> |
| Total aerobic microbial count | 1000 CFU/g max | <100 وحدة تشكيل المستعمرة/غرام | USP <61> |
| Yeast & mold | 100 CFU/g max | <10 CFU/g | USP <61> |
| الإشريكية القولونية | Absence/g | Not Detectable | USP <62> |
| السالمونيلا | Absence/g | Not Detectable | USP <62> |
| Staphylococcus aureus | Absence/g | Not Detectable | USP <62> |
الصياغة
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.
التطبيقات
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.
الكبسولات
For capsule formulas using a crystalline active ingredient in a defined powder blend.
الأجهزة اللوحية
For tablet development where powder handling and processing conditions are suitable.
مزيج المساحيق
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.
الجودة
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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