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.

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Product Information

アルファ・リポ酸

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

CAS番号. 1077-28-7

分子式 C8H14O2S2

分子量 206.33 g/mol

外観 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

数量 380 kg

Packing Size 25 kg / Drum

アッセイ 100.1%

粒子径 100% through 40 mesh

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

Technical Data

Alpha Lipoic Acid Specification

Test Item	仕様	Batch Result	Analysis Method
Identity & Physical Properties
外観	Slightly yellow crystal powder	準拠しています	Organoleptic
Identification A	Retention time of the major peak corresponds to the standard solution	準拠しています	USP <621>
Identification B	IR spectrum compares qualitatively with the standard	準拠しています	USP <197>
Melting point	60–62°C	60–62°C	USP <741>
乾燥減量	0.2% max	0.05%	USP <731>
点火時の残留物	0.1% max	0.08%	USP <281>
特定の回転	-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
残留溶剤
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
粒子径	100% through 40 mesh	準拠しています	USP <786>
重金属	10 ppm max	<10 ppm	USP <231>
カドミウム	1 ppm max	<0.005 ppm	USP <233>
ヒ素	1 ppm max	<0.01 ppm	USP <233>
リード	3 ppm max	<0.02 ppm	USP <233>
水星	0.1 ppm max	<0.005 ppm	USP <233>
Assay & Microbiological Tests
アッセイ	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>
大腸菌	Absence/g	Not Detectable	USP <62>
サルモネラ菌	Absence/g	Not Detectable	USP <62>
黄色ブドウ球菌	Absence/g	Not Detectable	USP <62>

配合

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.

カプセル Particle size and powder handling should be considered alongside the filling process and blend composition.

タブレット Flow, compaction and processing temperature should be considered during development.

パウダーブレンド 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.

粒子径 100% through 40 mesh · USP <786>

Melting point 60–62°C · USP <741>

アプリケーション

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.

カプセル

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

タブレット

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

パウダーブレンド

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

ドキュメント Certificate of Analysis available for product review

Sample Sample requests can be discussed before a commercial order

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