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Send EmailAzelaic Acid, Nonanedioic Acid, 123-99-9
AZELAIC ACID
SECTION 1: PRODUCT IDENTITY AND CHEMICAL IDENTIFICATION
| Parameter | Information |
|---|---|
| Product Name | Azelaic Acid |
| INCI Name | Azelaic Acid |
| Chemical Name (IUPAC) | Nonanedioic acid |
| Common Names | Azelaic Acid, 1,7-Heptanedicarboxylic acid, Anchoic acid |
| CAS Number | 123-99-9 |
| EC Number (EINECS) | 204-669-1 |
| REACH Registration Number | Available (varies by manufacturer) |
| Molecular Formula | C₉H₁₆O₄ |
| Molecular Weight | 188.22 g/mol |
| Chemical Class | Dicarboxylic acid; saturated aliphatic diacid |
| Functional Groups | Two carboxylic acid groups (-COOH) |
SECTION 2: CHEMICAL STRUCTURE
O O
‖ ‖
HO—C—(CH₂)₇—C—OH
Azelaic Acid
Nonanedioic Acid
C₉H₁₆O₄
HOOC — (CH₂)₇ — COOH
Structure: Linear saturated dicarboxylic acid
with 7 methylene groups between two carboxyl groups
| Parameter | Description |
|---|---|
| Molecular Formula | C₉H₁₆O₄ |
| Molecular Weight | 188.22 g/mol |
| Chemical Class | Dicarboxylic acid; saturated aliphatic |
| Structure | HOOC-(CH₂)₇-COOH |
| Number of Carbons | 9 |
| Functional Groups | Two carboxylic acid groups |
| SMILES | C(CCCC(=O)O)CCCC(=O)O |
| InChI | InChI=1S/C9H16O4/c10-8(11)6-4-2-1-3-5-7-9(12)13/h1-7H2,(H,10,11)(H,12,13) |
| InChI Key | BDJRBEYXGGNYIS-UHFFFAOYSA-N |
| Hydrogen Bond Donors | 2 |
| Hydrogen Bond Acceptors | 4 |
| Rotatable Bond Count | 8 |
| Polar Surface Area (PSA) | 74.6 Ų |
SECTION 3: PHYSICAL AND CHEMICAL PROPERTIES
| Property | Value | Test Method / Note |
|---|---|---|
| Appearance | White to off-white crystalline powder | Visual |
| Odor | Odorless or faint characteristic odor | Olfactometric |
| Molecular Weight | 188.22 g/mol | Calculated |
| Melting Point | 106.5 – 109°C | DSC / Capillary |
| Boiling Point | 286°C (decomposes at higher temperatures) | - |
| Density (20°C) | ~1.225 g/cm³ | - |
| Bulk Density | ~0.3-0.6 g/cm³ | - |
| Solubility in Water (20°C) | Slightly soluble (~2.4 g/L at 20°C) | General Method |
| Solubility in Hot Water | Moderately soluble | General Method |
| Solubility in Ethanol | Soluble | General Method |
| Solubility in Propylene Glycol | Soluble | General Method |
| Solubility in Oils | Very slightly soluble | General Method |
| Solubility in Acetone | Soluble | General Method |
| Solubility in Dimethyl Sulfoxide (DMSO) | Soluble | General Method |
| Log P (Octanol/Water) | ~1.57 (moderately hydrophilic) | Calculated |
| pKa1 (25°C) | ~4.53 (first carboxylic acid) | - |
| pKa2 (25°C) | ~5.33 (second carboxylic acid) | - |
| pH (Aqueous, saturated solution) | ~3.5-4.0 (acidic) | pH Meter |
| Flash Point | >150°C | - |
| Autoignition Temperature | >300°C | - |
| Vapor Pressure (25°C) | Very low (<0.01 mmHg) | - |
| Thermal Stability | Stable up to 200°C; decomposes at higher temperatures | - |
| Refractive Index (nD20) | ~1.472 (calculated) | - |
| Crystalline Structure | Monoclinic or triclinic | XRD |
| Hygroscopicity | Slightly hygroscopic | - |
SECTION 4: FUNCTIONAL PROPERTIES AND MECHANISM OF ACTION
| Property | Description |
|---|---|
| Anti-inflammatory Action | Inhibits reactive oxygen species (ROS) production and reduces inflammatory mediators (cytokines) in keratinocytes and neutrophils. Reduces inflammation in acne and rosacea. |
| Antimicrobial Activity | Exhibits bacteriostatic activity against Propionibacterium acnes (Cutibacterium acnes) and Staphylococcus epidermidis. Inhibits bacterial protein synthesis. |
| Keratolytic & Comedolytic Effect | Normalizes keratinization and reduces microcomedone formation. Prevents abnormal follicular hyperkeratinization. |
| Melanin Inhibition | Inhibits tyrosinase enzyme activity, reducing melanin synthesis. Effective in treating hyperpigmentation disorders such as melasma and post-inflammatory hyperpigmentation. |
| Antioxidant Activity | Scavenges free radicals and reactive oxygen species (ROS). Protects cells from oxidative stress. |
| Sebum Reduction | Reduces sebum production and normalizes sebaceous gland activity (limited effect). |
| Anti-proliferative Effect | Inhibits abnormal keratinocyte proliferation in the follicular epithelium. |
| Skin Penetration Enhancer | Due to its low molecular weight and slight hydrophilicity, it can penetrate the stratum corneum into the epidermis and upper dermis. |
SECTION 5: COMMERCIAL GRADES AND VARIANTS
| Grade / Type | Purity | Appearance | Primary Application |
|---|---|---|---|
| Pharmaceutical Grade (USP/EP) | ≥99.0% | White crystalline powder | Topical formulations (acne, rosacea, melasma) |
| Cosmetic Grade | ≥98.0% | White to off-white powder | Skincare formulations, anti-aging products |
| Technical Grade | ≥95.0% | Off-white to yellowish powder | Industrial applications, polymer synthesis |
| Micronized Grade | ≥99.0% | Micronized powder (particle size <10 μm) | High-performance topical formulations |
| High Purity Research Grade | ≥99.5% | White crystalline powder | Research & development, analytical standards |
| GMP Grade | ≥99.0% | White crystalline powder | Pharmaceutical manufacturing |
SECTION 6: PHARMACOLOGICAL PROPERTIES
| Parameter | Information |
|---|---|
| Mechanism of Action | • Reduces inflammatory mediators (IL-1β, IL-6, TNF-α, ROS) • Inhibits bacterial protein synthesis (C. acnes) • Inhibits tyrosinase activity (melanin) • Normalizes keratinocyte differentiation |
| Absorption (Topical) | Low systemic absorption (~4% of applied dose) |
| Penetration Depth | Reaches the epidermis and upper dermis |
| Time to Peak Effect | 1-3 months (acne); 2-4 months (hyperpigmentation) |
| Therapeutic Concentrations | 15% gel (rosacea); 20% cream (acne, melasma) |
| Onset of Action | 2-4 weeks (initial improvement); full effect 8-12 weeks |
| Adjunctive Therapy | Can be used with retinoids, benzoyl peroxide, or hydroquinone |
| Contraindications | Hypersensitivity to azelaic acid or formulation excipients |
| Pregnancy Category | Category B (USA) - no evidence of risk in studies |
SECTION 7: THERAPEUTIC APPLICATIONS AND USAGE
| Indication | Formulation | Recommended Concentration | Duration |
|---|---|---|---|
| Acne Vulgaris | Cream / Gel | 15-20% | 8-24 weeks |
| Papulopustular Rosacea | Gel / Foam | 15% | 8-16 weeks |
| Melasma | Cream / Gel | 15-20% | 12-24 weeks |
| Post-inflammatory Hyperpigmentation | Cream / Gel | 15-20% | 8-16 weeks |
| Actinic Keratosis | Cream | 15-20% (adjunctive) | Variable |
| Seborrheic Dermatitis | Cream / Gel | 15-20% (adjunctive) | Variable |
| Anti-aging (Fine Lines) | Cream / Serum | 5-10% (cosmetic) | Continuous |
SECTION 8: FORMULATION GUIDELINES AND TIPS
| Parameter | Recommendation |
|---|---|
| Typical Concentration | 15-20% for therapeutic use; 5-10% for cosmetic use |
| Vehicle Selection | Gel, cream, foam, or emulsion systems |
| Solubilization | • Use propylene glycol, dipropylene glycol, or ethoxydiglycol as solubilizers • Pre-dissolve in water phase at 60-70°C with alkalizing agents (e.g., NaOH, triethanolamine) for pH adjustment |
| pH Optimization | Optimal pH range: 4.0 – 5.5; neutral-slightly acidic pH improves tolerability |
| Penetration Enhancers | • Propylene glycol (10-20%) • Ethanol (5-10%) • DMSO (limited use) • Transcutol® (diethylene glycol monoethyl ether) |
| Lipid-based Systems | Solid lipid nanoparticles (SLNs), nanostructured lipid carriers (NLCs), and microemulsions improve penetration and reduce irritation |
| Stabilizers | Use antioxidants (Vitamin E, BHT) to prevent oxidation |
| Thickening Agents | Carbomer, xanthan gum, hydroxyethyl cellulose |
| Emollients | Caprylic/capric triglycerides, squalane, dimethicone to reduce irritation |
| Humectants | Glycerin, hyaluronic acid, pentylene glycol to maintain hydration |
| Compatibility | Compatible with most excipients; avoid high pH (>7) which reduces efficacy |
| Manufacturing Temperature | 60-70°C for dissolution; avoid prolonged heating (>100°C) causing degradation |
SECTION 9: TOPICAL PRODUCT COMPARISON
| Product Name | Concentration | Formulation | Indication | Manufacturer |
|---|---|---|---|---|
| Finacea® Gel | 15% | Gel | Rosacea, Acne | LEO Pharma |
| Finacea® Foam | 15% | Foam | Rosacea, Acne | LEO Pharma |
| Azelex® Cream | 20% | Cream | Acne, Melasma | Allergan |
| Skinoren® Cream | 20% | Cream | Acne, Rosacea | Bayer |
| AzClear® | 20% | Cream | Acne | Ego Pharmaceuticals |
| Ducray Kertyol® (with A.A.) | 15% | Cream | Acne, Rosacea | Pierre Fabre |
| The Ordinary Azelaic Acid | 10% | Serum | Acne, Hyperpigmentation | DECIEM |
| Paula's Choice Azelaic Acid | 10% | Booster | Acne, Rosacea | Paula's Choice |
SECTION 10: REGULATORY AND LEGISLATIVE STATUS
| Region / Authority | Status | Maximum Usage Rate | Description |
|---|---|---|---|
| USA (FDA) | Approved (Rx) | 15-20% | Approved for acne, rosacea; OTC monograph not available |
| European Union (EC) | Approved (Rx/OTC) | 15-20% | Approved topical formulation; REACH registered |
| Australia (TGA) | Approved (Rx) | 15-20% | Therapeutic Goods Administration approved |
| Canada (HC) | Approved (Rx) | 15-20% | Health Canada approved |
| Turkey | Approved (Rx) | 15-20% | Under Ministry of Health; KKDIK registered |
| Japan (MHLW) | Approved | 15-20% | Approved for acne treatment |
| China (NMPA) | Approved | 15-20% | Approved as Rx; 10% for cosmetic use |
| COSMOS (Cosmetic) | Permitted | Up to 10% | Natural cosmetic certification; allowed as natural ingredient |
| ECHA | Registered | - | REACH registered under 123-99-9 |
| California Prop 65 | Not Listed | - | Not listed as carcinogen or reproductive toxin |
SECTION 11: SAFETY PROFILE AND TOXICOLOGICAL ASSESSMENT
| Parameter | Value / Description |
|---|---|
| GHS Classification | Irritant (may cause skin and eye irritation) |
| Signal Word | Warning |
| Hazard Pictograms | GHS07 (Exclamation mark) |
| Hazard Statements (H-Codes) | H315 (Causes skin irritation), H319 (Causes serious eye irritation), H335 (May cause respiratory irritation) |
| Precautionary Statements (P-Codes) | P261, P264, P271, P280, P302+P352, P305+P351+P338, P312, P321, P332+P313, P337+P313, P362+P364, P403+P233, P405, P501 |
| Acute Oral Toxicity (LD50, Rat) | >5000 mg/kg (low toxicity) |
| Acute Dermal Toxicity (LD50, Rabbit) | >2000 mg/kg (low toxicity) |
| Skin Irritation | Mild to moderate irritant (concentration dependent) |
| Eye Irritation | Moderate irritant |
| Skin Sensitization | Rare (<1%); may cause sensitization in susceptible individuals |
| Carcinogenicity | Not classified as carcinogenic; IARC Group 3 (Not classifiable) |
| Mutagenicity | Not mutagenic (Ames test negative) |
| Reproductive Toxicity | Not toxic; Category B (USA) |
| Target Organ Toxicity | Skin, eyes; respiratory tract (dust inhalation) |
| Dermal Absorption (Human) | Low (~4-8% of applied dose) |
| Systemic Exposure | Very low; no significant systemic accumulation |
| Local Tolerability | Transient burning, stinging, pruritus, erythema, dryness (usually mild) |
| Fototoxicity | Not phototoxic |
| Photoallergy | Not photoallergenic |
| Comedogenicity | Non-comedogenic |
| Ecotoxicity (EC50, Daphnia) | >100 mg/L (low toxicity) |
| Bioaccumulation Potential | Low (hydrophilic, log P ~1.57) |
SECTION 12: FIRST AID MEASURES
| Route of Exposure | Action |
|---|---|
| Inhalation | If inhaled as powder, move to fresh air. Seek medical attention if respiratory irritation or symptoms persist. |
| Skin Contact | Wash with plenty of soap and water. Remove contaminated clothing. Seek medical attention if irritation develops or persists. |
| Eye Contact | Rinse thoroughly with plenty of water for at least 15 minutes. Keep eyelids open. Remove contact lenses if present. Seek immediate medical attention if irritation persists. |
| Ingestion | Rinse mouth with water. Do NOT induce vomiting. Drink 1-2 glasses of water. Seek medical attention. |
| Note | Symptomatic treatment is administered. No specific antidote available. |
SECTION 13: ADVERSE EFFECTS AND MANAGEMENT
| Adverse Effect | Frequency | Management |
|---|---|---|
| Burning / Stinging Sensation | Very common (>20%) | Application to damp skin; temporary; reduce frequency initially |
| Pruritus (Itching) | Common (10-20%) | Use emollients; reduce concentration; apply after moisturizer |
| Erythema (Redness) | Common (10-20%) | Use 15% gel instead of 20% cream; moisturize |
| Dryness / Scaling | Common (10-20%) | Use moisturizers; reduce frequency; 2-3 times/week initially |
| Skin Irritation | Common (5-15%) | Start with once daily application; use low concentration |
| Peeling / Flaking | Less common (<10%) | Use gentle cleansers; avoid other irritants |
| Contact Dermatitis | Rare (<1%) | Discontinue use; seek medical advice |
| Hypopigmentation | Very rare | Discontinue use; usually reversible |
SECTION 14: STORAGE AND SHELF LIFE
| Parameter | Information |
|---|---|
| Storage Conditions | Store in a cool (<25°C), dry, dark place; protect from direct sunlight, heat, and moisture. |
| Temperature Limits | 15-25°C (ideal); do not exceed 30°C |
| Humidity | Low humidity environment (slightly hygroscopic) |
| Light | Protect from UV light and direct sunlight |
| Air (Oxygen) | Protect against oxidation; keep containers tightly closed |
| Incompatible Materials | Strong oxidizing agents, strong bases, reducing agents |
| Container Requirements | Light and moisture proof containers: Amber glass jars, aluminum bags, opaque HDPE containers, double-lined PE bags |
| Shelf Life | 24-36 months (unopened original packaging, under proper storage conditions) |
| Shelf Life (After Opening) | 12-18 months (under proper storage conditions) |
| Signs of Degradation | Color change (yellowing), odor change, caking, changes in flow properties |
| Stability Warning | Can degrade under high temperature and humidity; oxidized product may form colored impurities |
SECTION 15: PACKAGING OPTIONS
| Packaging Type | Quantity / Capacity | Material | Application Area |
|---|---|---|---|
| Aluminum Foil Bag | 1 kg, 5 kg, 10 kg, 25 kg | Aluminum / PE (light and moisture proof) | Cosmetic & pharmaceutical industry |
| Plastic Drum (HDPE) | 25 kg, 50 kg | HDPE (opaque, with moisture barrier) | Industrial use, bulk supply |
| Amber Glass Jar | 100 g, 500 g, 1 kg | Amber glass (UV protected) | Pharmaceutical, laboratory |
| Kraft Bag (PE Lined) | 10 kg, 25 kg | Kraft paper / PE liner | Economical packaging |
| Fiber Drum | 25 kg, 50 kg | Fiber with PE lining | Industrial bulk supply |
| IBC Container | 500 kg, 1000 kg | UV-protected HDPE | Large-scale industrial supply |
SECTION 16: TRANSPORTATION INFORMATION
| Parameter | Information |
|---|---|
| UN Number | Not applicable (not classified as dangerous substance) |
| Hazard Class | Not applicable (except as irritant) |
| Packing Group | Not applicable |
| ADR/RID | Not classified as dangerous goods |
| IMDG Code | Not marine pollutant; not classified as dangerous goods |
| IATA (Air) | Not classified as dangerous goods; can be transported by air |
| Transport Temperature | Ambient temperature; protect from moisture and heat |
| Transport Precautions | Keep away from strong oxidizing agents; protect from sunlight |
| Spill Cleanup | Collect mechanically; clean with absorbent material; avoid dust generation |
| Marine Pollutant | No |
SECTION 17: QUALITY CONTROL AND ANALYTICAL METHODS
| Parameter | Test Method | Specification |
|---|---|---|
| Appearance | Visual | White to off-white crystalline powder |
| Odor | Olfactometric | Odorless or faint characteristic odor |
| Assay (Azelaic Acid) | HPLC / Titration | ≥99.0% (Pharm.); ≥98.0% (Cosmetic) |
| Melting Point | DSC / Capillary | 106.5 – 109°C |
| Water Content | Karl Fischer | ≤1.0% (Pharm.); ≤2.0% (Cosmetic) |
| Residue on Ignition | Gravimetric | ≤0.1% (Pharm.); ≤0.2% (Cosmetic) |
| Heavy Metals (Pb) | ICP-MS / USP <231> | ≤10 ppm |
| Arsenic (As) | ICP-MS | ≤2 ppm |
| Iron (Fe) | ICP-MS | ≤5 ppm |
| Chlorides (Cl) | Turbidimetric | ≤0.02% |
| Sulfates (SO₄) | Turbidimetric | ≤0.05% |
| Single Impurity (HPLC) | HPLC | ≤0.3% (Pharm.); ≤0.5% (Cosmetic) |
| Total Impurities (HPLC) | HPLC | ≤1.0% (Pharm.); ≤2.0% (Cosmetic) |
| Particle Size Distribution | Laser Diffraction / Sieve | As per customer specification |
| Color of Solution | Visual (USP) | Clear, colorless to pale yellow |
| Microbiological Purity | USP <61> | TAMC ≤10² CFU/g; TYMC ≤10¹ CFU/g |
| Elemental Impurities | USP <232> / ICH Q3D | As per limits |
SECTION 18: QUALITY SPECIFICATIONS
| Parameter | Specification (Pharmaceutical) | Specification (Cosmetic) | Test Method |
|---|---|---|---|
| Appearance | White crystalline powder | White to off-white powder | Visual |
| Assay (HPLC) | ≥99.0% | ≥98.0% | HPLC / Titration |
| Melting Point | 106.5-109°C | 106-109°C | Capillary |
| Water Content | ≤1.0% | ≤2.0% | Karl Fischer |
| Residue on Ignition | ≤0.1% | ≤0.2% | Gravimetric |
| Heavy Metals (Pb) | ≤10 ppm | ≤20 ppm | ICP-MS |
| Iron (Fe) | ≤5 ppm | ≤10 ppm | ICP-MS |
| Chlorides (Cl) | ≤0.02% | ≤0.05% | Turbidimetric |
| Sulfates (SO₄) | ≤0.05% | ≤0.1% | Turbidimetric |
| Single Impurity | ≤0.3% | ≤0.5% | HPLC |
| Total Impurities | ≤1.0% | ≤2.0% | HPLC |
| Microbiological Purity | TAMC ≤10² CFU/g | TAMC ≤10³ CFU/g | USP <61> |
SECTION 19: OTHER NAMES AND SYNONYMS
| Type | Name |
|---|---|
| INCI Name | Azelaic Acid |
| Chemical Name | Nonanedioic Acid |
| IUPAC Name | Nonanedioic acid |
| Common Names | Azelaic Acid, 1,7-Heptanedicarboxylic acid, Anchoic acid |
| Trade Names | Finacea®, Azelex®, Skinoren®, AzClear® |
| Abbreviations | AzA |
| CAS Number | 123-99-9 |
| EC Number | 204-669-1 |
| Beilstein Number | 1101093 |
| PubChem CID | 2266 |
| DrugBank ID | DB00548 |
| FDA UNII | F2VW3D43YT |
SECTION 20: GHS CLASSIFICATION AND LABELING
| Parameter | Information |
|---|---|
| GHS Classification | Skin Irritant Category 2; Eye Irritant Category 2A; Specific Target Organ Toxicity (STOT SE3) |
| Signal Word | Warning |
| Hazard Pictograms | GHS07 (Exclamation mark) |
| Hazard Statements (H-Codes) | H315 (Causes skin irritation), H319 (Causes serious eye irritation), H335 (May cause respiratory irritation) |
| Precautionary Statements (P-Codes) | P261, P264, P271, P280, P302+P352, P305+P351+P338, P312, P321, P332+P313, P337+P313, P362+P364, P403+P233, P405, P501 |
| NFPA 704 Classification | Health: 1, Flammability: 1, Reactivity: 0 |
SECTION 21: ENVIRONMENTAL IMPACT AND DISPOSAL
| Parameter | Information |
|---|---|
| Biodegradability | Readily biodegradable (OECD 301B) |
| Aquatic Toxicity (EC50) | >100 mg/L (Daphnia magna) - low toxicity |
| Aquatic Toxicity (LC50) | >100 mg/L (fish) - low toxicity |
| Soil Mobility | Moderate (hydrophilic, log P 1.57) |
| Bioaccumulation Potential | Low (hydrophilic, log P <3) |
| Persistence | Low; readily biodegradable |
| Disposal Method | Dispose of in accordance with local, regional, and national regulations |
| Incineration | Controlled incineration facilities; energy recovery possible |
| Sewer Discharge | Do not discharge into sewers or water resources in large quantities |
| Environmental Precautions | Prevent environmental spread during spills; collect with absorbent material |
| Ecotoxicity Note | Environmentally friendly; low ecotoxic potential |
SECTION 22: FREQUENTLY ASKED QUESTIONS
| Question | Answer |
|---|---|
| Q1: What is Azelaic Acid and what does it do? | Azelaic Acid is a naturally occurring dicarboxylic acid used topically to treat acne vulgaris, papulopustular rosacea, melasma, and hyperpigmentation. It has anti-inflammatory, antimicrobial, and melanin-inhibiting properties. |
| Q2: What concentration of Azelaic Acid is effective? | Therapeutic efficacy is typically seen at 15-20% concentrations. Formulations such as Finacea® (15% gel) and Azelex® (20% cream) are clinically proven. |
| Q3: Is Azelaic Acid safe for sensitive skin? | Yes, but initial use may cause mild burning, stinging, itching, and redness. These side effects are usually mild and temporary. Starting with once-daily application or using after moisturizer can improve tolerability. |
| Q4: How does Azelaic Acid work on acne? | It reduces inflammation, inhibits C. acnes bacterial growth, and normalizes keratinization to prevent comedone formation. It is effective for both inflammatory and non-inflammatory acne lesions. |
| Q5: Can Azelaic Acid lighten skin? | Yes, it inhibits tyrosinase enzyme activity, reducing melanin production. It is effective for melasma, post-inflammatory hyperpigmentation, and sunspots. |
| Q6: How long does it take for Azelaic Acid to work? | Initial improvement may be seen in 2-4 weeks, with significant results appearing after 8-12 weeks of consistent use. |
| Q7: Is Azelaic Acid natural? | Yes, Azelaic Acid occurs naturally in wheat, rye, barley, and is also produced by Malassezia fungi (yeast) on the skin. However, commercial production is usually by chemical synthesis. |
| Q8: Can Azelaic Acid be used with other topical acne treatments? | Yes, it is often used with retinoids, benzoyl peroxide, or hydroquinone. However, initial application should be gradual to avoid excessive irritation. |
| Q9: Is Azelaic Acid safe during pregnancy? | FDA Pregnancy Category B, indicating no evidence of risk in animal studies. However, medical advice should be sought before use during pregnancy. |
| Q10: Does Azelaic Acid cause photosensitivity? | No, Azelaic Acid does not cause phototoxicity or photoallergy. However, sunscreen should still be applied daily for overall skin protection. |
SECTION 23: QUICK REFERENCE TABLE
| Property | Value |
|---|---|
| CAS Number | 123-99-9 |
| INCI Name | Azelaic Acid |
| IUPAC Name | Nonanedioic Acid |
| Molecular Formula | C₉H₁₆O₄ |
| Molecular Weight | 188.22 g/mol |
| Appearance | White to off-white crystalline powder |
| Melting Point | 106.5 – 109°C |
| Solubility in Water | Slightly soluble (~2.4 g/L) |
| Log P | ~1.57 (moderately hydrophilic) |
| pKa1 / pKa2 | 4.53 / 5.33 |
| Primary Function | Anti-inflammatory, antimicrobial, melanin inhibitor |
| Therapeutic Concentrations | 15-20% (Rx); 5-10% (Cosmetic) |
| Shelf Life | 24-36 months (proper storage) |
| Storage | Cool (<25°C), dry, dark |
| GHS Classification | Irritant (GHS07) |
| Regulatory Status | FDA approved; EU approved |
| Main Applications | Acne, rosacea, melasma, hyperpigmentation |
SECTION 24: CRITICAL WARNINGS AND BEST PRACTICES
CRITICAL WARNINGS:
Local irritation: Burning, stinging, and itching are common, especially in the first 2-4 weeks. These are usually mild and transient. Start with once-daily application.
Use correct concentration: 15-20% for therapeutic use (prescription); 5-10% for cosmetic use (over-the-counter). Do not exceed recommended concentration.
Avoid contact with eyes and mucous membranes: Rinse immediately with water if contact occurs.
Do not use on open wounds: Use only on intact skin; avoid applying to broken or infected skin.
Photoprotection: Although not phototoxic, sunscreen is essential for treating hyperpigmentation.
Storage: Store in cool, dry, light-proof containers to prevent degradation and discoloration.
BEST PRACTICE RECOMMENDATIONS:
Titrate application: Start with once daily application; increase to twice daily after 2-4 weeks if tolerated.
Apply to clean, dry skin: Azelaic Acid absorbs better and causes less irritation when applied to clean, dry skin.
Moisturize: Use a gentle moisturizer before or after application to reduce irritation.
Patch test: Perform a patch test on the inner forearm before first use, especially for sensitive skin.
Sunscreen: Daily broad-spectrum sunscreen (SPF 30+) is essential, especially for hyperpigmentation treatment.
Avoid other irritants: Do not use with other harsh exfoliants (salicylic acid, glycolic acid) initially; add gradually.
Use gentle cleansers: Use mild, non-soap cleansers to avoid additional irritation.
Formulation: For formulation, pre-dissolve Azelaic Acid in a solvent (propylene glycol, ethanol) before adding to the oil or water phase. Adjust pH to 4.0-5.5.
Combination therapy: Can be combined with retinoids (adapalene, tretinoin) but apply Azelaic Acid in the morning and retinoid at night.
Patient education: Inform patients about expected initial side effects (mild burning, redness) and adherence for optimal results.
LEGAL DISCLAIMER:
The information provided in this document is based on our current knowledge and experience and is presented in good faith; however, it does not constitute a binding specification or guarantee as all conditions of use are beyond our control. This Technical Data Sheet is for informational purposes only. Users are responsible for testing suitability for their own applications. For complete safety, storage, use, handling, waste, and regulatory compliance information, please refer to the official Safety Data Sheet (SDS/MSDS) provided by the manufacturer/supplier.