Azelaic Acid Pure

Azelaic Acid Pure 99% Raw Material Powder — Pharmaceutical-Grade Skin Active for Cosmeceutical & Therapeutic Formulations

Shaanxi Hongda Phytochemistry Co., Ltd. offers pharmaceutical-grade Azelaic Acid Pure (CAS 123-99-9), extracted from grain or generated through oleic acid ozonolysis, with a ≥99% test. Hongda, a recognised producer with 20,000 m² production facilities, 3,000 tons yearly output, and Certifications including KOSHER, HALAL, BRC, ISO9001, and ISO22000, provides white crystalline powder with a melting point of 106.5-109°C and micronized particle size (D90 < 20μ This material fulfils USP/EP/BP pharmacopeial standards for B2B cosmeceutical and therapeutic buyers globally in 25 kg/drum with 3–7 working day lead times.

Product Introduction

Azelaic Acid Pure (Nonanedioic acid, C9H16O4) is a naturally occurring saturated dicarboxylic acid found in barley, wheat, and rye. “Pure” in particular refers to high-assay material, free of monocarboxylic acid impurities and heavy metals, which is a regulatory requirement for the manufacture of pharmaceuticals and cosmeceuticals.

This acid is different from AHAs or BHAs since it acts in three different ways: blocking tyrosinase to decrease melanin formation, normalising keratinization to remove blocked pores, and having bacteriostatic activity against Cutibacterium acnes. Together these actions make it a stable, non-teratogenic alternative for melasma, rosacea and inflammatory acne as opposed to hydroquinone and retinoids.

Third-Party Test Report

Every batch from Shaanxi Hongda is tested both in-house and through authorized third-party agencies including SGS and Eurofins. Testing covers:

· Purity (Assay): HPLC/GC confirmation of ≥99.0%

· Melting Point: 106.5–109°C (confirms crystal lattice integrity)

· Particle Size Distribution: Laser diffraction, D90 < 20μm

· Heavy Metals: Compliant with USP \<232>/\<233> for Pb, As, Hg

· Residual Solvents: GC testing per ICH Q3C limits

· Microbial Limits: Full bioburden screening before shipment

Test reports are available upon request for any production batch.

Azelaic Acid Pure Advantages

Pharmaceutical-grade purity at ≥99%

Ozonolysis by-products and short-chain acid impurities are removed through multi-stage purification, meeting USP, EP, and BP pharmacopeial standards. This directly reduces skin irritation risk in finished formulations.

Superior oxidative stability

Unlike Vitamin C (L-Ascorbic Acid), this active does not degrade under normal formulation conditions. It remains effective across a pH range of 4.0–5.0, making it compatible with a wide range of functional additives.

Micronized particle size (D90 < 20μm)

Fine particle distribution prevents the grittiness and sedimentation commonly seen in emulsions. It also improves suspension stability in serums and reduces nozzle clogging on production lines.

Non-teratogenic safety profile

Classified as FDA Pregnancy Category B, it is a preferred raw material for brands targeting pregnant or breastfeeding consumers — a market segment that cannot use retinoids or hydroquinone.

Azelaic Acid Pure Application

Pharmaceutical Dermatology (Rx)

Used at 15–20% concentrations in prescription creams and gels for rosacea and severe acne. High purity is required to minimize irritation on compromised skin barriers.

Cosmeceutical Serums

Formulated at 10–12% with co-solvents such as propanediol for hyperpigmentation and uneven texture correction. Suspension technology maintains active stability without sedimentation, delivering visible results without aggressive skin reactions.

Scalp and Hair Care (Trichology)

An emerging application in scalp tonics and shampoos for androgenetic alopecia. It acts as a 5-alpha reductase inhibitor, blocking the conversion of testosterone to DHT. Encapsulation technology is recommended for follicle penetration in surfactant-rich environments.

OEM / ODM Support

Shaanxi Hongda supports custom specifications for B2B buyers across pharma, cosmeceutical, and nutraceutical sectors.

· Custom particle size grades: standard or micronized based on your formulation needs

· Packaging customization: private labeling, adjusted fill weights, or branded drums

· Product formats: powder, premix, encapsulated formats available

· Documentation support: full COA, MSDS, TDS, and third-party test reports provided

Your dedicated account manager works with you from sampling through bulk production. Minimum order quantities and pricing are confirmed based on your volume requirements.

Production Process

This active is manufactured by Shaanxi Hongda using controlled ozonolysis of oleic acid, followed by multi-stage purification to eliminate short-chain acid by-products and residual solvents. The process is performed in more than 10 production lines within purifying workshops of 100,000 level.

The main steps are as below: raw material qualification → reaction and isolation → crystallisation → micronization (D90<20μm) → drying → QC testing → PE bag of double layer + fibre drum packaging. We check residual solvent levels by GC and these levels are below ICH Q3C limitations before we release any batch.

Why Choose Us?

Founded in 2001, Shaanxi Hongda Phytochemistry has been a “National High-tech Development Enterprise” since 2010. The plant covers an area of 20,000 m2 with an annual capacity of 3,000 tons.

The in-house SGS-standardized laboratory is equipped with HPLC, GC, UV and atomic absorption spectrophotometry. More than 20 R&D personnel at professor level are working on formulation development and quality testing. All products are traceable to source materials, subjected to in-process controls and tested prior to export.

Certifications: KOSHER, HALAL, BRC, ISO9001, ISO22000, cGMP, FSSC22000, ORGANIC (EU), ORGANIC (NOP), FDA, SC

FAQ

Q1: How pure is your azelaic acid?

A: Our substance is certified by HPLC or GC≥99.0%. This avoids the formation of by-products of ozonolysis such as short chain monocarboxylic acids that could sensitise the skin.

Q2: How can I prevent recrystallization in serum formulation?

A: Use a co-solvent solution such as Ethoxydiglycol or Propanediol. Add to heated phase at 40-45 degrees C. Not always is the goal to achieve full solubilization and micronized grades help stabilise the suspension.

Q3: What is the optimum pH of the formulation for activity?

A: A pH of 4.0-4.8 is ideal. This still allows for free acid forms required for skin penetration but within the amounts tolerated by the skin.

Q4. Can I use it with Niacinamide?

A: Yes. The combo works on both the inflammation and the pigmentation. Ensure the final formulation pH is consistent with the stability requirements of both actives to avoid niacin flush.

Q5: Is this material suitable for use in products related to pregnancy?

A. Yes. It is an FDA Pregnancy Category B product – a desirable ingredient in anti-acne and depigmentation solutions where retinoids are contraindicated.

Q6: What documentation is there for import compliance?

A: Full paperwork is available COA, MSDS, TDS, 3rd party SGS/Eurofins test results and copies of the certifications (HALAL, KOSHER, BRC, ISO) Regulatory support for selected countries upon request.

Contact Us

Ready to source pharmaceutical-grade material for your next formulation with Azelaic Acid Pure? Send your inquiry to duke@hongdaherb.com.