Project Description
Product Description
Minoxidil is a high-purity active pharmaceutical ingredient (API) used in topical formulations for hair growth support. It is a white to off-white crystalline powder with a molecular formula of C₉H₁₅N₅O and a molecular weight of 209.25 g/mol. Its mechanism of action involves the stimulation of hair follicles through the enhancement of blood flow and the prolongation of the anagen (growth) phase of the hair cycle.
Product Specifications
| Parameter | Specification | Test Method |
|---|---|---|
| Assay (C₉H₁₅N₅O, on dried basis) | 98.0% – 102.0% | HPLC |
| Appearance | White to off-white crystalline powder | Visual Inspection |
| Identification | Positive (HPLC retention time) | HPLC |
| Melting Range | 248 – 252°C | USP <741> |
| Loss on Drying | ≤ 1.0% | USP <731> |
| Residue on Ignition | ≤ 0.1% | USP <281> |
| Heavy Metals (Total) | ≤ 20 ppm | USP <231> / ICP-MS |
| Lead (Pb) | ≤ 2.0 mg/kg | ICP-MS |
| Arsenic (As) | ≤ 1.0 mg/kg | ICP-MS |
| Mercury (Hg) | ≤ 0.5 mg/kg | ICP-MS |
| Cadmium (Cd) | ≤ 0.5 mg/kg | ICP-MS |
| Chromium (Cr) | ≤ 0.5 mg/kg | ICP-MS |
| Residual Solvents | Meets USP <467> | GC |
| Limit of Nitrosamines | Meets regulatory requirements | LC-MS/MS |
| Particle Size | As per customer requirement | Sieve Analysis / Laser Diffraction |
| Total Plate Count | ≤ 1,000 CFU/g | USP <61> |
| Salmonella | Negative | USP <62> |
| E. coli | Negative | USP <62> |
Quality & Compliance
Xi’an Herb Bio manufactures Minoxidil as a high-purity API under strict quality systems to meet the requirements of pharmaceutical and OTC formulation buyers.
GMP Compliance: Our production facilities strictly follow GMP (Good Manufacturing Practice) guidelines for API manufacturing, ensuring consistent quality, purity, and impurity control across all batches. We maintain validated processes for synthesis, purification, and finished product release.
Certifications Held: Our manufacturing site is certified under ISO 9001 (Quality Management System) and ISO 22000 (Food Safety Management). We can also provide Kosher and Halal certifications upon request to support diverse market requirements.
Available Documentation: Every shipment includes a COA (Certificate of Analysis) and MSDS (Material Safety Data Sheet). We also provide stability data (accelerated and long-term), residual solvent reports, and nitrosamine impurity test reports upon request. For customers requiring regulatory submissions, we can make available relevant DMF (Drug Master File) information to support your product registration and regulatory filings.
Quality Standards Followed: Our Minoxidil meets USP (United States Pharmacopeia) standards for identity, purity, and impurities profile, with rigorous testing for related substances, heavy metals, residual solvents, and nitrosamine impurities to ensure compliance with global pharmaceutical and OTC regulatory requirements.
Application
Minoxidil is primarily used as an active pharmaceutical ingredient in over-the-counter (OTC) topical solutions and foams for hair loss treatment, typically at concentrations of 2% and 5%. It is also utilized in prescription compounded formulations at higher concentrations (5–10%) for specialized hair growth therapies, and in cosmetic hair care products such as tonics, serums, and scalp treatments at lower levels (0.1–2%). Additionally, Minoxidil serves as a reference standard in pharmaceutical research and quality control laboratories. Its high purity (≥98% USP) and consistent quality make it suitable for a wide range of topical applications, with formulations typically prepared in hydroalcoholic vehicles or foam bases to ensure optimal skin penetration and stability. For all applications, the final concentration and formulation should be validated according to the regulatory requirements of the target market.
Packing & Shipping
Why Choose Us & How to Order?
Located in China, we are the leading minoxidil supplier wholesale. If you purchase from us, we offer many additional convenient services, all of which cannot be easily provided by any other ingredient product and minoxidil wholesale supplier. Please, contact us to get FREE SAMPLE, COA and Nutrition Facts！
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