Azelaic Acid

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Cat Number

API0232195

CAS Number

123-99-9

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CAS Number

123-99-9

EINECS

204-669-1

Storage

Store at room temperature

Synonyms

Finacea; Anchoic acid; Lepargylic acid; 1,7-Heptanedicarboxylic acid; Azelex; Skinoren; Heptanedicarboxylic acid; 1,9-Nonanedioic acid

Molecular Formula

C9H16O4

Molecular Weight

188.22

Smiles

C(CCCC(=O)O)CCCC(=O)O

Appearance

White to cream solid

Melting Point

98°C

Boiling Point

286°C at 100 mmHg

Relative Density

1.029

General Description

Azelaic acid is a naturally occurring dicarboxylic acid with a 9-carbon straight-chain structure, produced by the yeast Malassezia furfur and also found in grains. It is a white to off-white crystalline powder, slightly soluble in water but soluble in alcohol.

Mechanism of Action

Azelaic acid exerts its effects through multiple mechanisms: it inhibits the growth of Propionibacterium acnes and Staphylococcus epidermidis via inhibition of bacterial protein synthesis. It normalizes keratinization by reducing the number of follicular keratotic plugs; and it reduces melanin synthesis by competitively inhibiting tyrosinase, the key enzyme in melanogenesis.

Application

Azelaic acid is indicated for the topical treatment of mild to moderate acne vulgaris and for the management of rosacea (papulopustular form). It is also used for the treatment of hyperpigmentation disorders, including melasma and post-inflammatory hyperpigmentation, due to its tyrosinase-inhibiting properties. The drug is effective in reducing both inflammatory and non-inflammatory lesions and is generally well-tolerated.

Azelaic acid (AZA) inhibited AML cell viability and induced apoptosis in a dose-dependent manner, suppressing phosphorylated Akt, Jab1, and Trx. AZA sensitized AML cells to Ara-C chemotherapy. In nude mouse xenografts, AZA reduced tumor growth. These findings suggest AZA has antineoplastic activity in AML.

Fig. 1 AZA inhibited cell proliferation and induced apoptosis in AML cells. (Pan Y, et al., 2017)

References

Pan Y, et al. Azelaic Acid Exerts Antileukemic Activity in Acute Myeloid Leukemia. Front Pharmacol. 2017;8:359.

In a double‑blind RCT (patients with mild‑to‑moderate facial acne), azelaic acid nanocrystal (AZA‑NC) hydrogel 10% achieved a 36.5% success rate at week 8 vs 30.4% with AZA cream 20% (P<0.001). AZA‑NC reduced inflammatory lesions by 39.2% and non‑inflammatory lesions by 34.6%, vs 33.8% and 28.0% with cream. Adverse events were mild. Low‑dose AZA‑NC hydrogel is safe and effective for acne.

Fig. 2 Patient flow diagram. (Tomić I, et al., 2021)

References

Tomić I, et al. Efficacy and Safety of Azelaic Acid Nanocrystal-Loaded In Situ Hydrogel in the Treatment of Acne Vulgaris. Pharmaceutics. 2021;13(4):567.

Does Azelaic Acid require protection from light during long-term storage?

It is relatively stable, but prolonged light exposure may cause slight discoloration. Store in light-resistant containers in a cool, dry place.

What is the recommended storage temperature for Azelaic Acid?

Store at controlled room temperature (15-25°C). Avoid excessive heat above 30°C, which can cause melting and decomposition.

Is Azelaic Acid stable in topical gel and cream formulations?

Yes, when formulated with preservatives and protected from light.

How is the impurity azelaic acid anhydride (a process-related impurity) monitored?

This impurity is quantified using a validated HPLC method with UV detection, ensuring it remains within pharmacopoeial limits.