特殊成分

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.

索取報價

Alpha Lipoic Acid product image

Product Information

硫辛酸粉末

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

分子式 C8H14O2S2

分子量 206.33 g/mol

外觀 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

數量 380 kg

Packing Size 25 kg / Drum

分析法 100.1%

顆粒尺寸 100% through 40 mesh

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

Technical Data

Alpha Lipoic Acid Specification

Test Item	規格	Batch Result	Analysis Method
Identity & Physical Properties
外觀	Slightly yellow crystal powder	符合	Organoleptic
Identification A	Retention time of the major peak corresponds to the standard solution	符合	USP <621>
Identification B	IR spectrum compares qualitatively with the standard	符合	USP <197>
Melting point	60–62°C	60–62°C	USP <741>
乾燥損失	0.2% max	0.05%	USP <731>
點火殘留物	0.1% max	0.08%	USP <281>
特定旋轉	-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
殘留溶劑
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
粒徑	100% through 40 mesh	符合	USP <786>
重金屬	10 ppm max	<10 ppm	USP <231>
鎘	1 ppm max	<0.005 ppm	USP <233>
砷	1 ppm max	<0.01 ppm	USP <233>
鉛	3 ppm max	<0.02 ppm	USP <233>
水銀	0.1 ppm max	<0.005 ppm	USP <233>
Assay & Microbiological Tests
分析法	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>
大腸桿菌	Absence/g	Not Detectable	USP <62>
沙門氏菌	Absence/g	Not Detectable	USP <62>
金黃色葡萄球菌	Absence/g	Not Detectable	USP <62>

配方

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.

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

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

粉末混合物 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.

粒徑 100% through 40 mesh · USP <786>

Melting point 60–62°C · USP <741>

應用

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.

膠囊

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

錠劑

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

粉末混合物

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.

品質

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

文件 Certificate of Analysis available for product review

Sample Sample requests can be discussed before a commercial order

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