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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

Bột Axit Alpha-Lipoic

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

Số CAS. 1077-28-7

Công thức phân tử C8H14O2S2

Trọng lượng phân tử 206,33 g/mol

Hình thức 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

Số lượng 380 kg

Packing Size 25 kg / Drum

Phương pháp định lượng 100.1%

Kích thước hạt 100% through 40 mesh

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

Technical Data

Alpha Lipoic Acid Specification

Test Item	Thông số kỹ thuật	Batch Result	Analysis Method
Identity & Physical Properties
Hình thức	Slightly yellow crystal powder	Tuân thủ	Organoleptic
Identification A	Retention time of the major peak corresponds to the standard solution	Tuân thủ	USP <621>
Identification B	IR spectrum compares qualitatively with the standard	Tuân thủ	USP <197>
Melting point	60–62°C	60–62°C	USP <741>
Mất mát do sấy khô	0.2% max	0.05%	USP <731>
Hàm lượng tro sau khi đốt	0.1% max	0.08%	USP <281>
Hệ số quay	-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
Dung môi còn lại
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
Kích thước hạt	100% through 40 mesh	Tuân thủ	USP <786>
Kim loại nặng	10 ppm max	<10 ppm	USP <231>
Cadmium	1 ppm max	<0.005 ppm	USP <233>
Asen	1 ppm max	<0.01 ppm	USP <233>
Chì	3 ppm max	<0.02 ppm	USP <233>
Thủy ngân	0.1 ppm max	<0.005 ppm	USP <233>
Assay & Microbiological Tests
Phương pháp định lượng	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>

Công thức

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.

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

Máy tính bảng Flow, compaction and processing temperature should be considered during development.

Hỗn hợp bột 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.

Kích thước hạt 100% through 40 mesh · USP <786>

Melting point 60–62°C · USP <741>

Ứng dụng

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.

Viên nang

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

Máy tính bảng

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

Hỗn hợp bột

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.

Chất lượng

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

Tài liệu Certificate of Analysis available for product review

Sample Sample requests can be discussed before a commercial order

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