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Send EmailClotrimazole, Clotrimazolum, 23593-75-1
CLOTRIMAZOLE
SECTION 1: PRODUCT IDENTITY AND CHEMICAL IDENTIFICATION
| Parameter | Information |
|---|---|
| Product Name | Clotrimazole |
| Chemical Name (IUPAC) | 1-[(2-Chlorophenyl)(diphenyl)methyl]-1H-imidazole |
| Common Names | Clotrimazole, Clotrimazolum, BAY 5097 |
| CAS Number | 23593-75-1 |
| EC Number (EINECS) | 245-764-4 |
| Molecular Formula | C₂₂H₁₇ClN₂ |
| Molecular Weight | 344.84 g/mol |
| Chemical Class | Azole antifungal; Imidazole derivative |
| Pharmacological Class | Antifungal agent (broad-spectrum) |
| Pharmacopoeia Grade | USP, EP, JP, BP |
SECTION 2: CHEMICAL STRUCTURE
Cl
|
C₆H₄
\
C
/ \
/ \
/ \
C₆H₅ C₆H₅
\ /
\ /
\ /
C
‖
N
/ \
/ \
/ \
CH CH
\ /
\ /
\ /
N
Clotrimazole
1-[(2-Chlorophenyl)(diphenyl)methyl]-1H-imidazole
C₂₂H₁₇ClN₂
Simplified Structure:
Cl
|
(C₆H₅)₂—C—(C₆H₄)—N
|
C
/ \
/ \
/ \
CH CH
\ /
\ /
\ /
N
Clotrimazole
Triphenylmethyl imidazole derivative
| Parameter | Description |
|---|---|
| Molecular Formula | C₂₂H₁₇ClN₂ |
| Molecular Weight | 344.84 g/mol |
| Chemical Class | Imidazole derivative; Azole antifungal |
| Functional Groups | Imidazole ring, chlorophenyl, diphenylmethyl |
| SMILES | C1=CC=C(C=C1)C(C2=CC=CC=C2)(C3=CC=CC=C3Cl)N4C=CN=C4 |
| InChI | InChI=1S/C22H17ClN2/c23-20-13-7-6-12-19(20)22(21-14-8-4-9-15-21,16-10-2-1-3-11-16)25-17-18-24-22/h1-15,17-18,22H |
| InChI Key | VNFPBHJOKIVQEB-UHFFFAOYSA-N |
| Hydrogen Bond Donors | 0 |
| Hydrogen Bond Acceptors | 2 |
| Rotatable Bond Count | 4 |
| Polar Surface Area (PSA) | 17.8 Ų |
| Optical Activity | Not optically active (achiral) |
| Steric Structure | Bond between triphenylmethyl group and imidazole ring |
SECTION 3: PHYSICAL AND CHEMICAL PROPERTIES
| Property | Value | Test Method / Note |
|---|---|---|
| Appearance | White to off-white crystalline powder | Visual |
| Odor | Odorless | Olfactometric |
| Molecular Weight | 344.84 g/mol | Calculated |
| Melting Point | 147 – 149°C | DSC / Capillary |
| Density (20°C) | ~1.25 g/cm³ (estimated) | - |
| Solubility in Water (25°C) | Very slightly soluble (~0.0001 mg/mL) | General Method |
| Solubility in Ethanol | Soluble (~20-30 mg/mL) | General Method |
| Solubility in Methanol | Soluble | General Method |
| Solubility in Propylene Glycol | Soluble (~5-10 mg/mL) | General Method |
| Solubility in DMSO | Soluble (~50-80 mg/mL) | General Method |
| Solubility in Chloroform | Soluble | General Method |
| Solubility in Acetone | Soluble | General Method |
| Solubility in PEG | Soluble | General Method |
| Log P (Octanol/Water) | ~5.5-6.0 (highly lipophilic) | Calculated / Experimental |
| pKa | ~4.7 (imidazole nitrogen protonation) | - |
| pH (Saturated aqueous solution) | ~6.5-7.0 (neutral) | pH Meter |
| Vapor Pressure (25°C) | Very low (<0.001 mmHg) | - |
| Flash Point | >150°C | - |
| Thermal Stability | Stable up to 200°C | - |
| Hygroscopicity | Not hygroscopic | - |
| Polymorphism | Known polymorphic forms (Form I, II, III) | XRD / DSC |
| Refractive Index | ~1.65 (estimated) | - |
| UV Maximum (λmax) | ~260-265 nm (methanol) | UV-VIS Spectrophotometer |
SECTION 4: PHARMACOLOGICAL PROPERTIES AND MECHANISM OF ACTION
| Property | Description |
|---|---|
| Pharmacological Class | Antifungal agent (Azole, Imidazole derivative) |
| Mechanism of Action | Inhibits the 14α-demethylase enzyme (CYP51) in the fungal cell membrane. Blocks ergosterol synthesis; Disrupts cell membrane integrity; Leads to fungal cell death. |
| Spectrum | Broad-spectrum antifungal; Dermatophytes, yeasts, molds, dimorphic fungi |
| Susceptible Organisms | • Candida albicans • Trichophyton rubrum • Trichophyton mentagrophytes • Epidermophyton floccosum • Microsporum canis • Malassezia furfur (Pityriasis versicolor) • Aspergillus species (limited) |
| Antibacterial Activity | Limited antibacterial activity (against Gram-positive bacteria) |
| Topical Bioavailability | Low; poorly absorbed through skin; Accumulates in stratum corneum and epidermis |
| Systemic Absorption | Very low in topical application (<0.5%); Well absorbed orally (systemic use limited) |
| Metabolism | Hepatic metabolism (CYP3A4) |
| Elimination | Mainly excreted in feces (~90%); Urine (~10%) |
| Plasma Half-Life | ~2-4 hours (oral administration) |
| Protein Binding | ~90-95% (albumin) |
| In Vitro MIC Values | • C. albicans: 0.5-2 µg/mL • T. rubrum: 1-4 µg/mL • M. furfur: 0.5-2 µg/mL |
SECTION 5: CLINICAL USE AND INDICATIONS
| Indication | Formulation | Concentration | Frequency | Duration |
|---|---|---|---|---|
| Tinea Pedis (Athlete's Foot) | Cream / Topical Solution | 1% | Twice daily | 2-4 weeks |
| Tinea Cruris (Jock Itch) | Cream / Powder | 1% | Twice daily | 2-4 weeks |
| Tinea Corporis (Body Ringworm) | Cream / Lotion | 1% | Twice daily | 2-4 weeks |
| Tinea Versicolor (Pityriasis Versicolor) | Cream / Topical Solution | 1% | 1-2 times daily | 2-4 weeks |
| Candidiasis (Cutaneous / Mucosal) | Cream / Vaginal Tablet | 1% / 100-500 mg | 1-2 times daily | 1-2 weeks |
| Vaginal Candidiasis | Vaginal Tablet / Cream | 100 mg / 500 mg / 1% | Once daily | 1-6 days |
| Oral Candidiasis (Thrush) | Lozenge / Oral Suspension | 10 mg | 4-5 times daily | 7-14 days |
| Dermatophytosis (Tinea Unguium - Off-label) | Topical Solution | 1% | 1-2 times daily | 6-12 months |
SECTION 6: COMMERCIAL GRADES AND VARIANTS
| Grade / Type | Purity | Particle Size | Primary Application |
|---|---|---|---|
| Pharmaceutical Grade (USP/EP) | ≥99.0% | Standard | Topical creams, ointments, lotions, vaginal tablets |
| Micronized Grade | ≥99.0% | D90 <10 μm (micronized) | High solubility formulations, better penetration |
| Research Grade (R&D) | ≥99.5% | Standard | Analytical standards, formulation development |
| GMP Grade | ≥99.0% | Standard / Micronized | Pharmaceutical manufacturing |
| Analytical Standard | ≥99.8% | Standard | HPLC reference standards |
SECTION 7: COMMERCIAL PRODUCT COMPARISON
| Brand Name | Strength / Concentration | Formulation | Indication | Manufacturer |
|---|---|---|---|---|
| Canesten® | 1% | Cream / Solution / Powder | Tinea, Candidiasis | Bayer |
| Lotrimin® | 1% | Cream / Lotion / Solution | Tinea, Candidiasis | Bayer / Generic |
| Clotrimaderm® | 1% | Cream | Tinea, Candidiasis | Generic |
| Gyne-Lotrimin® | 100 mg / 500 mg / 1% | Vaginal tablet / Cream | Vaginal candidiasis | Bayer |
| Canesten® 500 | 500 mg | Vaginal tablet | Vaginal candidiasis | Bayer |
| Clotrimazole (Generic) | 1% / 100 mg / 500 mg | Various | Tinea, Candidiasis | Multi-source |
SECTION 8: FORMULATION GUIDELINES
| Parameter | Recommendation |
|---|---|
| Concentration | 1% in topical formulations (standard); 100-500 mg in vaginal tablets |
| Vehicle | • Creams: O/W (oil-water) or W/O (water-oil) emulsions • Ointments: Hydrocarbon base (petrolatum, mineral oil) • Lotions: Alcohol-water or PEG-based • Solutions: Propylene glycol, ethanol, PEG |
| Melting Temperature | Melt at 60-70°C; avoid high temperatures (>80°C) causing degradation |
| pH Range | Optimum pH 4.0-7.0; More stable in acidic medium |
| Solvents | • Propylene glycol (5-20%) • Ethanol (5-20%) • Polyethylene glycol (PEG 400) • Dimethyl sulfoxide (DMSO, limited) |
| Surfactants | Nonionic (Tween 80, Span 80) and anionic (sodium lauryl sulfate) compatible; Incompatible with cationic at high concentrations |
| Emollients | Cetyl alcohol, stearic acid, stearyl alcohol, isopropyl myristate, squalane |
| Preservatives | Methyl paraben, propyl paraben, benzalkonium chloride, phenoxyethanol |
| Antioxidants | BHT, BHA, Vitamin E (to prevent oxidation) |
| Penetration Enhancers | Propylene glycol (5-20%), DMSO, ethanol, azone, Transcutol® |
| Thickeners | Carbomer, cetostearyl alcohol, xanthan gum, hydroxyethyl cellulose |
| Vaginal Tablet Formulation | Lactose, MCC, sodium starch glycolate, magnesium stearate, povidone |
| Compatibility | Compatible with most excipients; Avoid strong acids and bases; Incompatible with oxidizing agents |
| Sterilization | Autoclaving not recommended (degradation); Ionizing radiation (gamma) sterilization; Aseptic filtration (0.2 µm) |
| Topical Shelf Life | 24-36 months (proper storage) |
SECTION 9: QUALITY SPECIFICATIONS (USP/EP)
| Parameter | USP / EP Specification | Test Method |
|---|---|---|
| Appearance | White to off-white crystalline powder | Visual |
| Assay (on dried basis) | ≥99.0% - ≤101.0% | HPLC |
| Melting Point | 147 – 149°C | Capillary |
| Water Content | ≤0.5% | Karl Fischer |
| Residue on Ignition | ≤0.1% | Gravimetric |
| Heavy Metals | ≤20 ppm | USP <231> |
| Single Impurity | ≤0.3% | HPLC |
| Total Impurities | ≤0.7% | HPLC |
| Chloride | ≤0.02% | Titrimetric |
| Sulfate | ≤0.05% | Turbidimetric |
| Particle Size | Customer specific | Laser Diffraction |
| Microbiological Purity | TAMC ≤10² CFU/g; TYMC ≤10¹ CFU/g | USP <61> |
| E. coli | Negative | USP <62> |
| Salmonella | Negative | USP <62> |
| S. aureus | Negative | USP <62> |
| P. aeruginosa | Negative | USP <62> |
SECTION 10: ANALYTICAL METHODS AND QUALITY CONTROL
| Parameter | Test Method | Description |
|---|---|---|
| Assay | HPLC (USP) | C18 column, UV detector 254 nm, mobile phase: acetonitrile / pH 6.0 buffer (60:40) |
| Melting Point | Capillary (USP) | 147 – 149°C range |
| Water Content | Karl Fischer (USP) | ≤0.5% |
| Residue on Ignition | Gravimetric (USP) | ≤0.1% |
| Heavy Metals | ICP-MS / USP <231> | ≤20 ppm |
| Related Substances | HPLC (USP) | Single impurity ≤0.3%; Total ≤0.7% |
| Polymorphic Form | XRD / DSC | Form I or Form II (specified) |
| Solubility Test | USP / EP | Soluble in specified solvents |
| Particle Size | Laser Diffraction | D90 <10 μm (micronized grade) |
| UV Spectroscopy | UV-VIS | λmax ~260-265 nm (methanol) |
| IR Spectroscopy | KBr pellet | Characteristic peaks |
| Microbiological Test | USP <61> / <62> | Negative for pathogens |
SECTION 11: SAFETY PROFILE AND TOXICOLOGICAL ASSESSMENT
| Parameter | Value / Description |
|---|---|
| GHS Classification | Irritant; Skin irritation, eye irritation; Low acute toxicity |
| 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, P332+P313, P337+P313, P362+P364, P403+P233, P405, P501 |
| Acute Oral Toxicity (LD50, Rat) | >1000 mg/kg (low toxicity) |
| Acute Dermal Toxicity (LD50, Rabbit) | >2000 mg/kg (low toxicity) |
| Skin Irritation | Mild irritant (Category 2) |
| Eye Irritation | Mild-moderate irritant (Category 2A) |
| Skin Sensitization | May cause sensitization (rare) |
| Carcinogenicity | Not classified as carcinogenic |
| Mutagenicity | Not mutagenic (AMES test negative) |
| Reproductive Toxicity | No reproductive toxicity (rat) |
| Target Organs | Skin, eyes, respiratory tract (dust) |
| Drug Interactions | CYP3A4 inhibitor; Potential interaction with other azoles |
| Pregnancy Category | FDA Category B; No risk in animal studies; Use only if clearly necessary |
| Lactation | Unknown; Use with caution |
| Pediatric Use | Caution in children under 2 years of age |
| Local Tolerability | Well tolerated in topical application; Rare local irritation |
| Ecotoxicity | Moderate toxicity to aquatic organisms; Avoid release to environment |
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 | Remove contaminated clothing. Wash with plenty of soap and water. Seek medical attention if irritation develops. |
| Eye Contact | Rinse thoroughly with plenty of water for at least 15 minutes. Keep eyelids open. Remove contact lenses if present. Seek 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 | Severity | Management |
|---|---|---|---|
| Local Skin Irritation | Common (5-10%) | Mild | Temporary; treatment can be continued |
| Pruritus / Itching | Common (5-10%) | Mild | Temporary; antihistamines |
| Erythema / Redness | Common (5-10%) | Mild | Usually transient; reduced application |
| Burning / Stinging | Common (5-10%) | Mild | At application site; transient |
| Dryness / Scaling | Less common (2-5%) | Mild | Moisturizers; dose reduction |
| Rash / Urticaria | Rare (<1%) | Moderate | Discontinue treatment; antihistamines |
| Allergic Contact Dermatitis | Very rare (<0.1%) | Moderate-Severe | Discontinue treatment; corticosteroids |
| Nausea (Oral form) | Less common | Mild | Take with food |
SECTION 14: STORAGE AND SHELF LIFE
| Parameter | Information |
|---|---|
| Storage Conditions | Store in a cool (<25°C), dry, well-ventilated area; protect from light and moisture. |
| Temperature Limits | 15-25°C (ideal); do not exceed 30°C |
| Humidity | Low humidity environment (not hygroscopic) |
| Light | Light sensitive; Light-proof containers (amber glass, aluminum, HDPE) |
| Oxygen | Protect against oxidation; keep containers tightly closed |
| Incompatible Materials | Strong oxidizing agents, strong acids, strong bases |
| Container Requirements | Light-proof, moisture-proof containers: Amber glass bottles, aluminum foil bags, HDPE |
| Shelf Life | 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), caking, decreased solubility, HPLC impurity increase |
| Stability Warning | May degrade under light and moisture; Oxidized product may form impurities |
SECTION 15: PACKAGING OPTIONS
| Packaging Type | Quantity / Capacity | Material | Application Area |
|---|---|---|---|
| Fiber Drum | 25 kg | Fiber / PE liner | Pharmaceutical manufacturing, industrial supply |
| HDPE Drum | 25 kg, 50 kg | HDPE (opaque, moisture barrier) | Pharmaceutical, industrial supply |
| Aluminum Foil Bag | 1 kg, 5 kg, 10 kg | Aluminum / PE (light and moisture proof) | High purity, pharmaceutical |
| Amber Glass Bottle | 100 g, 500 g, 1 kg | Amber glass (UV protected) | Laboratory, analytical standards |
| Kraft Bag (PE Lined) | 10 kg, 25 kg | Kraft paper / PE liner | Economical packaging |
| 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 |
| Packing Group | Not applicable |
| ADR/RID | Not classified as dangerous goods |
| IMDG Code | Not marine pollutant |
| IATA (Air) | Not classified as dangerous goods; can be transported by air |
| Transport Temperature | Ambient temperature; protect from heat, moisture, and light |
| Transport Precautions | Light-proof packaging; keep away from strong oxidizing agents |
| Spill Cleanup | Collect mechanically; clean with absorbent material; avoid dust generation |
| Marine Pollutant | No |
SECTION 17: OTHER NAMES AND SYNONYMS
| Type | Name |
|---|---|
| Chemical Name (IUPAC) | 1-[(2-Chlorophenyl)(diphenyl)methyl]-1H-imidazole |
| Common Names | Clotrimazole, Clotrimazolum, BAY 5097 |
| Trade Marks | Canesten®, Lotrimin®, Clotrimaderm®, Gyne-Lotrimin®, Mycelex® |
| USP Name | Clotrimazole |
| EP Name | Clotrimazole |
| CAS Number | 23593-75-1 |
| EC Number | 245-764-4 |
| PubChem CID | 2812 |
| DrugBank ID | DB00257 |
| FDA UNII | G07GZ97H65 |
| ATC Code | D01AC01 (topical), G01AF02 (vaginal) |
SECTION 18: GHS CLASSIFICATION AND LABELING
| Parameter | Information |
|---|---|
| GHS Classification | Skin Irritant Category 2; Eye Irritant Category 2A; 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, P332+P313, P337+P313, P362+P364, P403+P233, P405, P501 |
| NFPA 704 Classification | Health: 1, Flammability: 1, Reactivity: 0 |
SECTION 19: ENVIRONMENTAL IMPACT AND DISPOSAL
| Parameter | Information |
|---|---|
| Biodegradability | Limited; slowly biodegradable |
| Aquatic Toxicity (EC50) | >10 mg/L (Daphnia magna) - moderate toxicity |
| Aquatic Toxicity (LC50) | >10 mg/L (fish) - moderate toxicity |
| Soil Mobility | Low-Moderate (lipophilic) |
| Bioaccumulation Potential | Moderate-High (log P ~5.5-6.0) |
| Persistence | Moderate; may persist in the environment |
| 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 |
| Environmental Precautions | Prevent environmental spread during spills; collect with absorbent material |
| Ecotoxicity Note | May pose potential risk to aquatic ecosystems; should be used with care |
SECTION 20: FREQUENTLY ASKED QUESTIONS
| Question | Answer |
|---|---|
| Q1: What is Clotrimazole and what does it do? | Clotrimazole is a broad-spectrum antifungal agent. It is effective against dermatophytes, yeasts (Candida), and molds. It is used to treat athlete's foot, jock itch, vaginal yeast infections, and pityriasis versicolor. |
| Q2: How does Clotrimazole work? | It inhibits the 14α-demethylase enzyme in the fungal cell membrane, blocking ergosterol synthesis. This disrupts cell membrane integrity and leads to fungal cell death. |
| Q3: Is Clotrimazole safe? | It has a good safety profile for topical use. Local side effects such as skin irritation, burning, or itching are rare. Systemic absorption is very low. |
| Q4: How long does Clotrimazole take to work? | Symptom improvement usually begins within a few days. However, full treatment requires 2-4 weeks (tinea infections) or 1-2 weeks (vaginal candidiasis). |
| Q5: Can Clotrimazole be used during pregnancy? | FDA Pregnancy Category B. No risk has been shown in animal studies. Use during pregnancy only if clearly necessary. |
| Q6: What are the side effects of Clotrimazole? | Local skin irritation, redness, itching, burning sensation. Rarely allergic reactions. Nausea may occur with oral forms. |
| Q7: What is the difference between Clotrimazole and other antifungals? | Clotrimazole belongs to the imidazole class (azoles). Terbinafine (allylamine) and nystatin (polyene) have different mechanisms of action. Clotrimazole is broad-spectrum. |
| Q8: Why is micronized Clotrimazole preferred? | Micronized clotrimazole has a smaller particle size (D90 <10 μm). This provides better solubility and skin penetration in formulations. |
| Q9: What is the shelf life of Clotrimazole? | 36 months under proper storage conditions (cool, dry, light-protected). |
| Q10: Is Clotrimazole soluble in water? | No, it is very slightly soluble (~0.0001 mg/mL). It is lipophilic and soluble in organic solvents such as ethanol, propylene glycol, and DMSO. |
SECTION 21: QUICK REFERENCE TABLE
| Property | Value |
|---|---|
| CAS Number | 23593-75-1 |
| Molecular Formula | C₂₂H₁₇ClN₂ |
| Molecular Weight | 344.84 g/mol |
| Appearance | White to off-white crystalline powder |
| Melting Point | 147 – 149°C |
| Water Solubility | Very slightly soluble (~0.0001 mg/mL) |
| Log P | ~5.5-6.0 (lipophilic) |
| Primary Function | Antifungal (azole) |
| Clinical Indications | Tinea pedis, Tinea cruris, Candidiasis, Pityriasis versicolor |
| Typical Topical Concentration | 1% |
| Pharmacopoeia Grade | USP, EP, JP, BP |
| Shelf Life | 36 months |
| Storage | Cool (<25°C), dry, light-protected |
| GHS Classification | Irritant (GHS07) |
| FDA Pregnancy Category | B |
| Main Applications | Topical antifungal, vaginal antifungal |
SECTION 22: CRITICAL WARNINGS AND BEST PRACTICES
CRITICAL WARNINGS:
Light sensitivity: Clotrimazole is light sensitive. Store in light-proof containers (amber glass, aluminum, HDPE).
Skin/eye irritation: Avoid skin and eye contact. Wash with plenty of water if contact occurs.
Pregnancy: FDA Category B. Use during pregnancy only if clearly necessary.
Drug interactions: CYP3A4 inhibitor. Potential interactions with other drugs.
Micronization: Micronized form provides better penetration but dust control is mandatory.
High temperature: Do not keep above melting point (~147°C) for extended periods (degradation).
Sterilization: Autoclaving not recommended. Use gamma radiation or aseptic filtration.
BEST PRACTICE RECOMMENDATIONS:
Formulation: 1% clotrimazole is the standard concentration for topical formulations. Melt in the oil phase at 60-70°C (oil-water emulsion).
Solubilization: Use propylene glycol, ethanol, or PEG 400 for dissolution. Do not add directly to the water phase.
Penetration enhancement: Use propylene glycol (5-20%) or Transcutol® to improve skin penetration.
pH control: Optimum pH 4.0-7.0. More stable in acidic medium.
Preservative addition: Add methyl paraben/propyl paraben or phenoxyethanol to topical formulations.
Stability studies: Degradation profile under light, moisture, and temperature; shelf life determination.
Quality control: Assay (HPLC), melting point, water content, heavy metals, microbiological purity.
Micronized use: Micronized clotrimazole (D90 <10 μm) is preferred for formulations requiring high solubility and penetration.
GMP compliance: Manufacture in accordance with pharmacopoeia (USP/EP) standards.
Patient education: Inform patients and physicians about treatment duration, application frequency, and possible side effects.
LEGAL DISCLAIMER:
The information provided in this document is based on our current knowledge and experience and is presented in good faith. However, as all conditions of use are beyond our control, it does not constitute a binding specification or guarantee. This Technical Data Sheet is for informational purposes only. Users are responsible for testing suitability for their own applications and for complying with all local, regional, and national regulations. 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. Clotrimazole is a pharmaceutical active ingredient; its use must be under the supervision of a healthcare professional.