Product Overview
- Product Name: Dutasteride
- Molecular Formula: C27H30F6N2O2
- Molecular Weight: 528.53
- CAS Number: 164656-23-9
- Drug Class: Steroidal hormone drug
What is Dutasteride?
Dutasteride is the world’s first dual inhibitor of type 1 and type 2 5α-reductase and belongs to the class of 4-azasteroids.It is a clinically commonly used active pharmaceutical ingredient, primarily used to treat benign prostatic hyperplasia and male androgenetic alopecia.
Common formulations of Dutasteride include 0.5 mg oral soft capsules; it is also available in a combination formulation with Tamsulosin.
In addition, Dutasteride can be used in the development of topical formulations; local administration effectively reduces the systemic side effects associated with oral formulations.
Highassay's Advantages
Highassay is a Chinese supplier of Dutasteride API, specializing in providing Polymorph II—the same crystalline form as the originator drug—and delivering compliant, stable raw materials to pharmaceutical companies worldwide.
Our Dutasteride powder has a purity of ≥98% and complies with USP and EP standards. We provide comprehensive documentation support (including DMF, COA, and MSDS) and ensure there are no patent issues regarding the originator’s crystal form, making the product suitable for the direct production and R&D of various formulations.
Highassay Dutasteride API utilizes the thermodynamically stable Form II, which resists phase transformation and offers moderate solubility and excellent processing characteristics; this ensures a perfect match for your production requirements while guaranteeing the dissolution rate and bioavailability of your finished products.
Buy Dutasteride,choose Highassay.Please feel free to contact us to request samples or inquire about pricing; we will respond within 24 hours with the latest quote.
Dutasteride uses
Dutasteride acts selectively on target cells in the prostate and scalp hair follicles, achieving its therapeutic effect through its pharmacological action.
- Regarding the prostate, prostate cells contain 5α-reductase; the intake of Dutasteride effectively reduces DHT levels, helping to shrink prostate volume. Clinical data indicate that its efficacy in reducing prostate volume is more than 30% greater than that of single-target inhibitors.
- 5α-reductase and androgen receptors are present in the hair follicle cells of the scalp; the drug Dutasteride effectively prevents hair follicle miniaturization and regrows hair by lowering DHT levels.
Specification of Dutasteride
- Specification of Dutasteride
| Item | Standard Specification |
| Appearance | White to off-white crystalline powder |
| Solubility | Freely soluble in DMSO (62 mg/mL); slightly soluble in ethanol (6 mg/mL); practically insoluble in water (<1 mg/mL) |
| Assay (on dried basis) | 97.0% – 102.0% (HPLC) |
| Purity | ≥ 98% |
| Specific Rotation | +14° to +18° (in methanol solution) |
| Loss on Drying | ≤ 0.5% |
| Residue on Ignition | ≤ 0.1% |
| Heavy Metals | ≤ 10 ppm |
| Related Substances | Total impurities ≤ 1.5%; single impurity ≤ 0.1% |
| Melting Point | 242–250 ºC |
| Storage | Preserve in a tightly closed container, protected from light, in a cool and dry place |
No. While both drugs share the same indications, Dutasteride is generally more potent and has a longer-lasting effect, whereas Finasteride offers better tolerability.
Therefore, neither is absolutely superior to the other; the choice depends on the patient’s specific circumstances.
Dutasteride mesotherapy is a local delivery method used to treat androgenetic alopecia, in which Dutasteride is injected directly into the hair follicles of the balding area via scalp microneedling.
No. Dutasteride is not safe for women, particularly those who are pregnant, planning a pregnancy, or breastfeeding, as the drug carries a known risk of causing fetal birth defects.
3–5 weeks.
The usual dosage of Dutasteride is 0.5 mg per day.
Dutasteride Mechanism of Action
Dutasteride blocks the conversion of testosterone to dihydrotestosterone (DHT) by competitively inhibiting type I and type II 5α-reductase in the body, effectively lowering DHT levels in prostate and scalp tissues (reducing serum DHT levels by over 90% and intra-prostatic DHT levels by approximately 94%), thereby alleviating symptoms of prostatic hyperplasia and inhibiting hair loss.
Dutasteride Packaging Specifications
- Standard Industrial Packaging: Available in 1kg aluminum foil bags and 25kg fiber drums, suitable for large-scale production and long-term inventory stocking.
- Experimental/Trial Packaging: Small-quantity packaging (e.g., 100g) is available to meet needs for laboratory testing, formulation development, and pilot-scale trials.
- Customized Packaging: Flexible customization of packaging specifications is available to meet specific customer requirements.
Dutasteride Pricing and Minimum Order Quantity (MOQ)
Highassay offers flexible MOQs and tiered pricing. Please provide details regarding specifications and quantities, and we will send you the latest pricing within 24 hours.
Dutasteride Documentation
Please contact the Highassay sales team to obtain supporting documents such as MSDS and COA.
