Azelaic Acid Solution (40% Azelaic Acid, Water-Soluble) is a professional topical-drug compounding ingredient supplied as a honey-colored, water-soluble liquid concentrate containing 40% azelaic acid.

This product is for pharmaceutical compounding and manufacturing only. It is not for direct consumer use and is not a finished medicine.

Azelaic acid (nonanedioic acid) is a saturated dicarboxylic acid used in topical dermatology. Finished topical drug references include 15% azelaic acid gel/foam for inflammatory papules and pustules of mild-to-moderate rosacea and 20% azelaic acid cream for mild-to-moderate inflammatory acne. This 40% solution is intended as a high-active liquid input that helps formulators build aqueous or aqueous-glycol topical systems without first dispersing dry azelaic acid powder.

Mechanistically, azelaic acid is relevant to acne and rosacea formulations through antimicrobial activity, support for normalization of follicular keratinization, comedone control, and anti-inflammatory/anti-redness formulation positioning. The exact clinical mechanism in rosacea is not fully established, so claims for finished products must remain consistent with the local drug registration and the final dosage form.

Technical Identity:

Active: Azelaic Acid 40% w/w in water-soluble liquid format

CAS Number: 123-99-9

Synonyms: Nonanedioic acid; 1,7-heptanedicarboxylic acid

Molecular Formula: C9H16O4

Molecular Weight: 188.22 g/mol

Delivered Active Calculation:

Pharmaceutical Applications:

- Topical acne products, gels, creams, lotions, and serums where azelaic acid is the active component

- Rosacea-oriented topical preparations where local regulation permits azelaic acid drug compounding

- Aqueous or aqueous-glycol base development where a liquid azelaic acid input is easier to process than powder

- Prototype studies comparing 10%, 15%, and 20% delivered azelaic acid in different vehicle systems

Typical Usage Levels:

Use 25-50% of this 40% solution to deliver 10-20% azelaic acid in the finished product. Typical development point: 37.5% product delivers 15% azelaic acid. Validate pH, irritation profile, viscosity, preservative efficacy, and active assay in the final formula.

Mixing and Formulation Guidance:

Add into the aqueous phase or during cool-down with moderate mixing. Maintain the final system around pH 4.0-6.0 unless the target drug specification requires otherwise. Strong neutralization or high pH can increase salt formation and may change skin feel, irritation profile, preservative performance, and delivered free-acid fraction. Avoid strong oxidants and unnecessary high heat; confirm compatibility with thickeners, electrolytes, preservatives, and packaging.

Product Characteristics:

Physical state: Liquid solution

Appearance: Clear to slightly hazy honey-amber liquid

Active content: 40% azelaic acid

Solubility: Water-soluble / water-compatible solution format

Storage:

Store tightly closed at room temperature, protected from heat, moisture, and direct light. Prevent freezing and prolonged high-temperature exposure. Re-test after opening if clarity, color, odor, or assay changes are observed.

Regulatory Note: Finished products containing azelaic acid may be regulated as drugs, cosmetics, or other categories depending on jurisdiction, concentration, claims, and dosage form. Use only by qualified formulators and manufacturers under applicable regulatory controls.