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FINASTERIDE
SECTION 1: PRODUCT IDENTITY AND CHEMICAL IDENTIFICATION
| Parameter | Information |
|---|---|
| Product Name | Finasteride |
| Chemical Name (IUPAC) | N-(1,1-dimethylethyl)-3-oxo-4-aza-5α-androst-1-ene-17β-carboxamide |
| Common Names | Finasteride, Finasteridum, MK-906 |
| CAS Number | 98319-26-7 |
| EC Number (EINECS) | 620-534-3 |
| Molecular Formula | C₂₃H₃₆N₂O₂ |
| Molecular Weight | 372.55 g/mol |
| Chemical Class | 5α-reductase inhibitor; steroid derivative; 4-azasteroid |
| Biopharmaceutical Class (BCS) | Class II (low solubility, high permeability) |
SECTION 2: CHEMICAL STRUCTURE
O
‖
C—NH—C(CH₃)₃
/
/
/
/
O C
‖ / \
C C \
/ \ / \
/ \ / \
/ \ / \
C C C C
\ / \ /
\ / \ /
\ / \ /
C C /
| | /
| | /
N C
/ \ / \
/ \ / \
/ \ / \
C C C C
\ / \ /
\ / \ /
\ / \ /
C C
| |
| |
H H
Finasteride
C₂₃H₃₆N₂O₂
4-Azasteroid Structure
Simplified Structure:
O
‖
H₃C—C—NH—C—C(CH₃)₃
|
[Steroid Ring System]
|
HN——C=O
‖
O
Finasteride
4-Aza-5α-androst-1-en-3-one-17β-carboxamide
| Parameter | Description |
|---|---|
| Molecular Formula | C₂₃H₃₆N₂O₂ |
| Molecular Weight | 372.55 g/mol |
| Chemical Class | 4-Azasteroid; 5α-reductase inhibitor |
| Steroid Skeleton | Androstane derivative (C19 steroid) |
| Functional Groups | Carboxamide (-CONH-C(CH₃)₃), 3-oxo group, 4-aza group (N) |
| SMILES | CC(C)(C)NC(=O)[C@H]1CC[C@H]2[C@H]3C@H[C@H]4CC@@HCC[C@@H]4C3=O |
| InChI | InChI=1S/C23H36N2O2/c1-14-6-7-15-16-8-9-18-22(3)11-10-17(26)23(27)24-19(22)20(16)25(18)21(15)12-14/h10-11,14-16,18,20-21H,6-9,12H2,1-5H3,(H,24,26,27)/t14-,15-,16-,18-,20-,21-,22-/m0/s1 |
| InChI Key | DBPKMCANMOWFGP-RWMBKGLWSA-N |
| Hydrogen Bond Donors | 2 |
| Hydrogen Bond Acceptors | 2 |
| Rotatable Bond Count | 3 |
| Polar Surface Area (PSA) | 58.2 Ų |
| Optical Activity | Optically active (chiral) |
| Stereocenters | 4 stereocenters |
SECTION 3: PHYSICAL AND CHEMICAL PROPERTIES
| Property | Value | Test Method / Note |
|---|---|---|
| Appearance | White to off-white crystalline powder | Visual |
| Odor | Odorless | Olfactometric |
| Molecular Weight | 372.55 g/mol | Calculated |
| Melting Point | ~250-254°C (decomposes) | DSC / Capillary |
| Density (20°C) | ~1.25 g/cm³ (estimated) | - |
| Solubility in Water (25°C) | Low (~0.03-0.04 mg/mL) | General Method |
| Solubility in Ethanol | Soluble (~10-15 mg/mL) | General Method |
| Solubility in Methanol | Soluble | General Method |
| Solubility in Chloroform | Soluble | General Method |
| Solubility in DMSO | Soluble (~20-30 mg/mL) | General Method |
| Solubility in Acetonitrile | Moderately soluble | General Method |
| Solubility in Propylene Glycol | Slightly soluble | General Method |
| Log P (Octanol/Water) | ~3.0-3.5 (lipophilic) | Calculated / Experimental |
| pKa | ~5.5-6.0 (nitrogen protonation) | - |
| pH (Saturated aqueous solution) | ~6.5-7.0 (neutral) | pH Meter |
| Vapor Pressure (25°C) | Very low | - |
| Flash Point | >150°C | - |
| Thermal Stability | Stable up to 200°C | - |
| Hygroscopicity | Low (not hygroscopic) | - |
| Polymorphism | Known polymorphic forms exist | XRD / DSC |
| Refractive Index | ~1.58 (estimated) | - |
SECTION 4: PHARMACOLOGICAL PROPERTIES AND MECHANISM OF ACTION
| Property | Description |
|---|---|
| Pharmacological Class | 5α-reductase inhibitor (Type II) |
| Mechanism of Action | Inhibits the 5α-reductase enzyme (Type II and III) which catalyzes the conversion of testosterone to dihydrotestosterone (DHT). |
| Selectivity | Type II 5α-reductase inhibitor (~100 times more selective than Type I) |
| Enzyme Inhibition (IC50) | ~5-10 nM (Type II 5α-reductase) |
| Plasma DHT Reduction | ~65-70% reduction in serum DHT levels following oral administration |
| Testosterone Level | ~10-15% increase in serum testosterone levels (due to DHT inhibition) |
| Clinical Indications | • Androgenetic alopecia (hair loss) - 1 mg/day • Benign prostatic hyperplasia (BPH) - 5 mg/day |
| Onset of Action | • Hair loss: 3-6 months • BPH: 6-12 months |
| Maximum Effect | • Hair loss: 12-24 months • BPH: 12-24 months |
| Plasma Half-Life (t½) | ~6-8 hours (young males); ~8-10 hours (elderly males) |
| Oral Bioavailability | ~65-80% |
| Protein Binding | ~90-93% (primarily albumin and α1-acid glycoprotein) |
| Metabolism | Hepatic (CYP3A4 mediated) - approximately 4-5 metabolites |
| Elimination | • Urine: ~39% (as metabolites) • Feces: ~57% (as metabolites) |
| Volume of Distribution (Vd) | ~76-100 L |
| Steady-State | Achieved within 5-7 days |
SECTION 5: CLINICAL USE AND INDICATIONS
| Indication | Dose | Frequency | Duration | Notes |
|---|---|---|---|---|
| Androgenetic Alopecia (Males) | 1 mg | Once daily | Continuous | Males only; slows hair loss, promotes new hair growth |
| Benign Prostatic Hyperplasia (BPH) | 5 mg | Once daily | Continuous | Reduces prostate volume, improves urinary flow |
| Prostate Cancer (Chemoprevention) | 5 mg | Once daily | Variable | High-risk patients; clinical trials |
| Hirsutism (Females - off-label) | 1-5 mg | Once daily | Variable | Off-label use in females; contraindicated during pregnancy due to teratogenic risk |
SECTION 6: COMMERCIAL GRADES AND VARIANTS
| Grade / Type | Purity | Appearance | Primary Application |
|---|---|---|---|
| Pharmaceutical Grade (USP/EP) | ≥99.0% | White crystalline powder | Tablet manufacturing (1 mg, 5 mg) |
| Micronized Grade | ≥99.0% | Micronized powder (D90 <10 μm) | High solubility formulations |
| Research Grade (R&D) | ≥99.5% | White crystalline powder | Analytical standards, formulation development |
| GMP Grade | ≥99.0% | White crystalline powder | Pharmaceutical manufacturing |
| Analytical Standard | ≥99.8% | White crystalline powder | HPLC standards, reference materials |
SECTION 7: COMMERCIAL PRODUCT COMPARISON
| Brand Name | Strength | Indication | Manufacturer | Formulation |
|---|---|---|---|---|
| Propecia® | 1 mg | Androgenetic alopecia | Merck Sharp & Dohme | Film-coated tablet |
| Proscar® | 5 mg | BPH | Merck Sharp & Dohme | Film-coated tablet |
| Finast® | 1 mg, 5 mg | Alopecia, BPH | Generic | Film-coated tablet |
| Fintrol® | 5 mg | BPH | Generic | Film-coated tablet |
| Finpecia® | 1 mg | Alopecia | Generic | Film-coated tablet |
| Prosteride® | 1 mg, 5 mg | Alopecia, BPH | Generic | Film-coated tablet |
SECTION 8: BIOPHARMACEUTICAL PROPERTIES
| Parameter | Value / Description |
|---|---|
| BCS Class | Class II (Low solubility, high permeability) |
| Solubility (pH 1.0) | ~0.02-0.03 mg/mL |
| Solubility (pH 6.8) | ~0.03-0.04 mg/mL |
| Dissolution Rate | pH dependent (faster in acidic medium) |
| Intestinal Permeability | High (Caco-2: Papp >10⁻⁶ cm/s) |
| Absorption Site | Small intestine (duodenum, jejunum) |
| Fasting/Feeding Effect | Absorption not affected by food |
| Systemic Exposure | Linear pharmacokinetics (1-5 mg range) |
| Peak Plasma Concentration (Cmax) | • 1 mg: ~30-40 ng/mL • 5 mg: ~150-200 ng/mL |
| Peak Time (Tmax) | ~1-2 hours |
| Plasma Half-Life (t½) | ~6-8 hours |
| Steady-State | Achieved within 5-7 days |
| Accumulation Factor | ~1.5-2.0 (with daily dosing) |
SECTION 9: ADVERSE EFFECTS AND SAFETY PROFILE
| Adverse Effect | Frequency | Severity | Management |
|---|---|---|---|
| Decreased Libido | Common (5-10%) | Mild-Moderate | Dose reduction; temporary, resolves within 1-2 weeks |
| Erectile Dysfunction | Common (3-8%) | Moderate | Temporary; generally reversible after treatment discontinuation |
| Ejaculation Disorder | Common (2-5%) | Mild | Reduced semen volume; generally asymptomatic |
| Gynecomastia | Less common (<2%) | Mild-Moderate | Breast tenderness, enlargement; rarely requires surgery |
| Depression | Less common (<2%) | Moderate-Severe | Antidepressants; may require treatment discontinuation |
| Allergic Reaction | Rare (<1%) | Mild-Severe | Antihistamines; emergency management for anaphylaxis |
| Testicular Pain | Rare (<1%) | Mild | Temporary; analgesics |
| Liver Function Abnormalities | Very rare (<0.1%) | Moderate-Severe | Liver function tests; treatment discontinuation |
| Rhabdomyolysis | Very rare (<0.01%) | Severe | Emergency management; treatment discontinuation |
SECTION 10: CONTRAINDICATIONS AND WARNINGS
| Condition | Description |
|---|---|
| Pregnancy | Absolute contraindication. Women who are or may become pregnant must not use finasteride. Teratogenic effect (genital abnormalities in male fetuses). |
| Breastfeeding | Should not be used by nursing mothers. |
| Children | Not indicated for use in males under 18 years of age. |
| Women | Women of childbearing potential must not use finasteride (teratogenic risk). |
| Liver Disease | Caution in patients with severe hepatic impairment. |
| Prostate Cancer | Prostate cancer must be ruled out before initiating therapy (PSA levels are affected). |
| PSA Testing | Finasteride reduces PSA levels by ~50%. This effect must be considered when interpreting PSA test results. |
| Drug Interactions | • CYP3A4 inhibitors (ketoconazole, itraconazole, ritonavir): May increase finasteride levels • Combination with other 5α-reductase inhibitors (dutasteride) is not recommended |
SECTION 11: DRUG INTERACTIONS
| Drug / Substance | Interaction Type | Severity | Management |
|---|---|---|---|
| CYP3A4 Inhibitors (Ketoconazole, Itraconazole, Ritonavir) | Decreased finasteride metabolism; increased plasma levels | Moderate | Dose adjustment; monitoring |
| CYP3A4 Inducers (Rifampin, Phenytoin) | Increased finasteride metabolism; decreased plasma levels | Low-Moderate | Clinical monitoring; efficacy assessment |
| Dutasteride (Other 5α-reductase inhibitors) | Increased pharmacological effect | Moderate-Severe | Combination not recommended |
| Warfarin | INR changes (rare) | Low | INR monitoring |
| Digoxin | No expected change in digoxin levels | Low | Monitoring not required |
| Theophylline | No expected change in theophylline levels | Low | Monitoring not required |
SECTION 12: FIRST AID MEASURES
| Route of Exposure | Action |
|---|---|
| Inhalation | If inhaled as powder, move to fresh air. Seek medical attention if respiratory 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 immediate medical attention. |
| Note | No specific antidote available. Symptomatic treatment is administered. Pregnant women should not crush or split finasteride tablets (risk of transdermal absorption). |
SECTION 13: STORAGE AND SHELF LIFE
| Parameter | Information |
|---|---|
| Storage Conditions | Store in a cool (<25°C), dry, light-protected place; protect from moisture. |
| Temperature Limits | 15-25°C (ideal); do not exceed 30°C |
| Humidity | Low humidity environment (not hygroscopic) |
| Light | Protect from UV light and direct sunlight (photodegradation potential) |
| 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 | 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), caking, decreased solubility, HPLC impurity increase |
| Stability Warning | May degrade under light and moisture; oxidized product may form impurities |
SECTION 14: PACKAGING OPTIONS
| Packaging Type | Quantity / Capacity | Material | Application Area |
|---|---|---|---|
| Amber Glass Bottle | 10 g, 25 g, 50 g, 100 g | Amber glass (UV protected) | Pharmaceutical manufacturing, laboratory, R&D |
| Aluminum Foil Bag | 1 kg, 5 kg, 10 kg, 25 kg | Aluminum / PE (light and moisture proof) | Pharmaceutical raw material supply |
| HDPE Drum | 25 kg, 50 kg | HDPE (opaque, moisture barrier) | Large-scale pharmaceutical manufacturing |
| Fiber Drum (PE Lined) | 25 kg, 50 kg | Fiber / PE liner | Industrial supply |
| Blister (Ready-to-Use) | 30 tablets, 60 tablets, 90 tablets | PVC/PCTFE / Aluminum foil | Consumer product (Propecia, Proscar) |
| HDPE Plastic Bottle | 30, 60, 90, 100 tablets | HDPE (child-resistant cap) | Generic tablet products |
SECTION 15: 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 16: QUALITY CONTROL AND ANALYTICAL METHODS
| Parameter | Test Method | Specification |
|---|---|---|
| Appearance | Visual | White to off-white crystalline powder |
| Odor | Olfactometric | Odorless |
| Assay (Finasteride) | HPLC / UV | ≥99.0% (USP/EP) |
| Melting Point | DSC / Capillary | 250-254°C (decomposes) |
| Water Content | Karl Fischer | ≤0.5% |
| Residue on Ignition | Gravimetric | ≤0.1% |
| Heavy Metals (Pb) | ICP-MS / USP <231> | ≤10 ppm |
| Arsenic (As) | ICP-MS | ≤1 ppm |
| HPLC Impurities | HPLC | Single impurity ≤0.2%; Total ≤0.5% |
| Chloride | USP / EP | ≤0.05% |
| Sulfate | Turbidimetric | ≤0.1% |
| Particle Size (Micronized) | Laser Diffraction | D90 <10 μm (micronized grade) |
| Polymorphic Form | XRD / DSC | Form I or Form II (specified) |
| Optical Rotation | Polarimetry | [α]D = +10° to +14° (c=1, CHCl₃) |
| Microbiological Purity | USP <61> | TAMC ≤10² CFU/g; TYMC ≤10¹ CFU/g |
SECTION 17: QUALITY SPECIFICATIONS (USP/EP)
| Parameter | Specification | Test Method |
|---|---|---|
| Appearance | White to off-white crystalline powder | Visual |
| Assay (on dried basis) | ≥99.0% - ≤101.0% | HPLC |
| Melting Point | 250-254°C (decomposes) | Capillary |
| Water Content | ≤0.5% | Karl Fischer |
| Residue on Ignition | ≤0.1% | Gravimetric |
| Heavy Metals | ≤10 ppm | USP <231> |
| Single Impurity | ≤0.2% | HPLC |
| Total Impurities | ≤0.5% | HPLC |
| Optical Rotation | +10° to +14° (c=1, CHCl₃) | Polarimetry |
| Organic Volatile Impurities | Within specification limits | GC |
| Microbiological Purity | TAMC ≤10² CFU/g; TYMC ≤10¹ CFU/g | USP <61> |
SECTION 18: OTHER NAMES AND SYNONYMS
| Type | Name |
|---|---|
| Chemical Name (IUPAC) | N-(1,1-dimethylethyl)-3-oxo-4-aza-5α-androst-1-ene-17β-carboxamide |
| Common Names | Finasteride, Finasteridum, MK-906 |
| Trade Marks | Propecia®, Proscar®, Finast®, Fintrol®, Finpecia®, Prosteride® |
| USP Name | Finasteride |
| EP Name | Finasteride |
| CAS Number | 98319-26-7 |
| EC Number | 620-534-3 |
| PubChem CID | 57363 |
| DrugBank ID | DB01216 |
| FDA UNII | 57GNO57U7G |
| ATC Code | D11AX10 (hair loss); G04CB01 (BPH) |
SECTION 19: GHS CLASSIFICATION AND LABELING
| Parameter | Information |
|---|---|
| GHS Classification | Reproductive Toxicity Category 2 (H361f), Skin Irritant Category 2 (H315) |
| Signal Word | Warning |
| Hazard Pictograms | GHS07 (Exclamation mark), GHS08 (Health Hazard) |
| Hazard Statements (H-Codes) | H315 (Causes skin irritation), H361f (Suspected of damaging fertility), H373 (May cause damage to organs through prolonged or repeated exposure) |
| Precautionary Statements (P-Codes) | P201, P202, P264, P280, P302+P352, P308+P313, P332+P313, P362+P364, P405, P501 |
| NFPA 704 Classification | Health: 2, Flammability: 1, Reactivity: 0 |
SECTION 20: ENVIRONMENTAL IMPACT AND DISPOSAL
| Parameter | Information |
|---|---|
| Biodegradability | Limited; slowly biodegradable (steroid structure) |
| Aquatic Toxicity (EC50) | >10 mg/L (Daphnia magna) - moderate toxicity |
| Aquatic Toxicity (LC50) | >10 mg/L (fish) - moderate toxicity |
| Soil Mobility | Moderate (lipophilic) |
| Bioaccumulation Potential | Moderate-High (log P ~3.0-3.5) |
| 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 21: FREQUENTLY ASKED QUESTIONS
| Question | Answer |
|---|---|
| Q1: What is Finasteride and what does it do? | Finasteride is a medication that inhibits the 5α-reductase enzyme, blocking the conversion of testosterone to DHT. It is used to treat male pattern hair loss (androgenetic alopecia) and benign prostatic hyperplasia (BPH). |
| Q2: How effective is Finasteride for hair loss? | Clinical studies show that 1 mg/day finasteride slows hair loss by 80-90% and promotes new hair growth in 60-70% of men. |
| Q3: What are the side effects of Finasteride? | The most common side effects are decreased libido (5-10%), erectile dysfunction (3-8%), and ejaculatory disorders (2-5%). These side effects are generally reversible upon treatment discontinuation. |
| Q4: Can women use Finasteride? | No. Finasteride is absolutely contraindicated in women of childbearing potential and pregnant women. It can cause genital abnormalities in male fetuses (teratogenic effect). |
| Q5: How long does Finasteride take to work? | For hair loss, initial results are seen in 3-6 months; maximum effect is achieved in 12-24 months. For BPH, improvement in urinary symptoms is seen in 6-12 months. |
| Q6: Can PSA testing be done while on Finasteride? | Yes, but finasteride reduces PSA levels by approximately 50%. This effect must be considered when interpreting PSA test results (PSA value should be multiplied by 2). |
| Q7: Can Finasteride be used with other hair loss treatments? | Yes, finasteride can be used in combination with minoxidil (topical + oral). This combination may be more effective than either treatment alone. |
| Q8: What happens if I stop taking Finasteride? | When finasteride treatment is discontinued, DHT levels return to normal within 3-6 months, and hair loss returns to pre-treatment levels. For BPH, prostate size may enlarge again. |
| Q9: Why is Finasteride dangerous for pregnant women? | Finasteride can disrupt the development of the external genitalia in male fetuses (hypospadias, other genital anomalies). Pregnant women should not handle crushed or split finasteride tablets. |
| Q10: What is the difference between Finasteride 5 mg and 1 mg? | The 1 mg formulation is approved for hair loss (Propecia®), while 5 mg is approved for BPH (Proscar®). Both doses reduce DHT levels by 65-70%, but different doses are used for different indications. |
SECTION 22: QUICK REFERENCE TABLE
| Property | Value |
|---|---|
| CAS Number | 98319-26-7 |
| Molecular Formula | C₂₃H₃₆N₂O₂ |
| Molecular Weight | 372.55 g/mol |
| Appearance | White crystalline powder |
| Melting Point | 250-254°C (decomposes) |
| Water Solubility | Low (~0.03 mg/mL) |
| Log P | ~3.0-3.5 (lipophilic) |
| Primary Function | 5α-reductase inhibitor (Type II) |
| Clinical Indications | Androgenetic alopecia (1 mg); BPH (5 mg) |
| Bioavailability | ~65-80% |
| Plasma Half-Life | ~6-8 hours |
| Protein Binding | ~90-93% |
| Metabolism | Hepatic (CYP3A4) |
| Elimination | Urine ~39%; Feces ~57% |
| Shelf Life | 24-36 months |
| Storage | Cool (<25°C), dry, light-protected |
| GHS Classification | Reproductive Toxicity (GHS08), Warning |
| FDA Approval | Approved (Propecia® 1 mg; Proscar® 5 mg) |
| Teratogenic Risk | Yes (male fetus) - Contraindicated in women |
SECTION 23: CRITICAL WARNINGS AND BEST PRACTICES
CRITICAL WARNINGS:
Teratogenic risk: Finasteride is absolutely contraindicated in women of childbearing potential and pregnant women. Even contact with crushed or split tablets may pose a risk to a male fetus.
Side effects: Sexual side effects (decreased libido, erectile dysfunction) are common and may be reversible after treatment discontinuation, but may be persistent in some patients.
PSA effect: Finasteride reduces PSA levels by ~50%. This effect must be considered when interpreting PSA test results.
Liver disease: Caution and monitoring are required in patients with severe hepatic impairment.
Prostate cancer: Prostate cancer must be ruled out before initiating therapy.
Drug interactions: Concomitant use with CYP3A4 inhibitors may increase finasteride levels.
Combination with dutasteride: Concomitant use with other 5α-reductase inhibitors (dutasteride) is not recommended.
BEST PRACTICE RECOMMENDATIONS:
Dosage: 1 mg/day for hair loss, 5 mg/day for BPH. Doses should never be confused.
Administration: Can be taken with or without food; absorption is not affected.
Discontinuation: When treatment is stopped, hair loss returns to pre-treatment levels within 6-12 months. BPH symptoms may recur.
PSA monitoring: Annual PSA testing should be performed; results should be interpreted considering the finasteride effect.
Liver function tests: Liver function tests should be monitored with high-dose or long-term use.
Pregnancy prevention: Women of childbearing potential should not handle finasteride tablets (transdermal absorption risk).
Stability studies: Finasteride stability in pharmaceutical formulations; effects of light, moisture, and temperature should be evaluated.
Quality control: Assay (HPLC), melting point, water content, heavy metals, microbiological purity tests should be performed regularly.
Patient education: Patients should be informed about sexual side effects, pregnancy risk, PSA test effects, and treatment discontinuation outcomes.
Cold chain: Not required; storage at room temperature (15-25°C) is sufficient.
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. Finasteride is a prescription medication; its use must be under the supervision of a healthcare professional.