Pharmaceutical Grade Azelaic Acid Powder is a high-purity dicarboxylic acid used in pharmaceutical and cosmetic formulations requiring stable quality, controlled impurities, and consistent batch performance.
It is suitable for topical dermatological products, skincare formulations, and OEM/ODM manufacturing applications.
Key Features:
- ≥99.0% HPLC purity
- Pharmaceutical-grade impurity control
- Stable formulation performance
- Suitable for GMP manufacturing
- Custom specifications available
Key Specifications
|
Parameter |
Specification |
|
Product Name |
Azelaic Acid Powder |
|
Grade |
Pharmaceutical Grade |
|
Appearance |
White to off-white crystalline powder |
|
Assay (HPLC) |
≥ 99.0% |
|
Molecular Formula |
C9H16O4 |
|
Molecular Weight |
188.22 |
|
Melting Point |
106 – 109°C |
|
Loss on Drying |
≤ 0.5% |
|
Residue on Ignition |
≤ 0.1% |
|
Heavy Metals |
≤ 10 ppm |
|
Lead (Pb) |
≤ 2 ppm |
|
Particle Size |
80–100 Mesh or customized |
|
Solubility |
Slightly soluble in water |
|
Identification |
IR / HPLC Complies |
|
Microbial Limits |
Complies with USP standards |
Industry Use
Pharmaceutical Industry
Used as a high-purity raw material in topical dermatological formulations, including acne treatment creams, anti-rosacea gels, and other prescription-grade skin treatment products.
Cosmetic & Personal Care Industry
Applied as a functional ingredient in skincare formulations such as creams, serums, lotions, and scalp care products where controlled composition and formulation stability are required.
OEM/ODM Manufacturing
Suitable for use in large-scale manufacturing environments requiring consistent batch quality and reliable supply for cosmetic and pharmaceutical formulation production.
Manufacturing Capability & Quality System
Tobrand operates an integrated manufacturing and quality control system designed for high-purity raw material consistency. The company operates a fully integrated supply chain system covering raw material sourcing, production, quality inspection, warehousing, and global distribution.
Production & Quality Infrastructure
GMP-certified production environment
ISO9001, HACCP, KOSHER, and Halal certified facilities
In-house inspection center equipped with HPLC, GC, IR, and MS analytical instruments
Quality Control System
Every batch undergoes strict multi-stage quality control:
Raw material selection and verification
In-process quality monitoring
Final product release testing
Full COA documentation per batch
Analytical Standards
- HPLC assay for purity verification
- Heavy metals, moisture, and microbial limit testing
- IR identification for structural confirmation
- Optional third-party laboratory testing for export compliance
This system ensures consistent product quality across large-scale industrial supply.
Documentation & Compliance Support
To support international regulatory and customs requirements, Tobrand provides full documentation:
- Certificate of Analysis (COA) for every batch
- Material Safety Data Sheet (MSDS)
- Technical Data Sheet (TDS)
- Specification sheet
- KOSHER / Halal certificates (if required)
- Export compliance documentation
- Third-party inspection support (SGS / BV / Intertek available upon request)
- Sample COA available for pre-shipment evaluation and quality verification
Global Supply Chain & Warehousing
Tobrand operates overseas warehouses in the United States and Europe, enabling faster regional distribution and reduced international lead time.
- Local stock availability for selected products
- Faster fulfillment for bulk and repeat orders
- Reduced shipping time for key global markets
- Support for long-term supply agreement
Packaging & Storage
Standard Packaging
25 kg fiber drum with double-layer PE inner lining
Customized Packaging
1 kg / 5 kg / 10 kg options available for sampling, OEM, and trial production
Storage Conditions
Store in a cool, dry, and well-ventilated environment
Store below 25 °C
Avoid direct sunlight and moisture exposure
Seal tightly after opening
Shelf Life
24 months under recommended storage conditions
Transportation
Non-hazardous chemical material suitable for standard international transport
FAQ