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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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Alpha Lipoic Acid product image

Product Information

กรดแอลฟาไลโปอิกผง

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

เลขที่ CAS. 1077-28-7
สูตรโมเลกุล C8H14O2S2
น้ำหนักโมเลกุล 206.33 กรัม/โมล
ลักษณะ 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
ปริมาณ 380 kg
Packing Size 25 kg / Drum
การวิเคราะห์ 100.1%
ขนาดอนุภาค 100% through 40 mesh

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

Technical Data

Alpha Lipoic Acid Specification

Test Item ข้อกำหนด Batch Result Analysis Method
Identity & Physical Properties
ลักษณะ Slightly yellow crystal powder สอดคล้องกับ Organoleptic
Identification A Retention time of the major peak corresponds to the standard solution สอดคล้องกับ USP <621>
Identification B IR spectrum compares qualitatively with the standard สอดคล้องกับ USP <197>
Melting point 60–62°C 60–62°C USP <741>
การสูญเสียจากการอบแห้ง 0.2% max 0.05% USP <731>
คราบตกค้างเมื่อเกิดการเผาไหม้ 0.1% max 0.08% USP <281>
การหมุนเฉพาะ -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
สารละลายที่เหลือ
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
ขนาดอนุภาค 100% through 40 mesh สอดคล้องกับ USP <786>
โลหะหนัก 10 ppm max <10 ppm USP <231>
แคดเมียม 1 ppm max <0.005 ppm USP <233>
อาร์เซนิค 1 ppm max <0.01 ppm USP <233>
หัวหน้า 3 ppm max <0.02 ppm USP <233>
เมอร์คิวรี 0.1 ppm max <0.005 ppm USP <233>
Assay & Microbiological Tests
การวิเคราะห์ 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>
อี.โคไล Absence/g Not Detectable USP <62>
ซัลโมเนลลา Absence/g Not Detectable USP <62>
Staphylococcus aureus Absence/g Not Detectable USP <62>

สูตร

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.

แคปซูล Particle size and powder handling should be considered alongside the filling process and blend composition.
แท็บเล็ต Flow, compaction and processing temperature should be considered during development.
ผงผสม 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.

ขนาดอนุภาค 100% through 40 mesh · USP <786>
Melting point 60–62°C · USP <741>

การประยุกต์ใช้

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.

01

แคปซูล

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

02

แท็บเล็ต

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

03

ผงผสม

For dry formulations where particle characteristics and blend uniformity meet the finished-product requirements.

04

Gummies & Chewables

For formulations where heat exposure and finished-product characteristics can be controlled.

คุณภาพ

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
เอกสาร Certificate of Analysis available for product review
Sample Sample requests can be discussed before a commercial order

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