Key Properties of Minoxidil
Product Name | Minoxidil |
---|---|
Synonyms | 2,4-Diamino-6-piperidinopyrimidine-3-oxide |
CAS No. | 38304-91-5 |
Chemical Formula | C9H15N5O |
Grade | Pharmaceutical grade |
Appearance | White to off-white crystalline powder |
Molar Mass | 209.26 g/mol |
Solubility | Slightly soluble in water; soluble in DMSO and ethanol |
Manufacturing process of Minoxidil
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Raw Material Preparation:
- Procure high-quality chemical precursors (e.g., 2,4-diamino-6-chloropyrimidine and a piperidine derivative).
- Verify that all raw materials meet strict purity standards before use.
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Synthesis & Oxidation:
- Synthesis: Under controlled conditions (temperature, pH, and solvent environment), combine the raw materials in a reaction vessel. A nucleophilic substitution reaction forms the core minoxidil structure.
- Oxidation: Introduce an oxidation step to convert the intermediate into active minoxidil by adding the N-oxide functional group. This step is critical for the compound’s therapeutic activity.
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Purification, Quality Control & Packaging:
- Purification: Employ techniques such as crystallization, filtration, or chromatography to remove impurities and obtain a high-purity product.
- Quality Control: Conduct comprehensive tests to ensure the final product meets quality standards, complying with Good Manufacturing Practice (GMP) and ISO:9001 requirements.
- Packaging: Once approved, Pack Minoxidil in a clear poly bag and twist the mouth of the bag. Secure it with a PVC strip. Place this bag inside another poly bag, twist its mouth, and secure it with a PVC strip. Insert these bags into a triple-laminated aluminum bag and seal it properly. Finally, place the sealed aluminum bag in an HDPE container. Store Minoxidil in a tightly closed, light-resistant container at a temperature below 30°C.
Applications of Minoxidil
Technical Specifications of Minoxidil
Sr.No. | Test | Specification |
---|---|---|
1 | Description | White to off-white crystalline powder |
2 | Assay | 98.0–102.0% (of label claim) |
3 | Identification | |
By IR | Infrared absorption spectrum must match that of the official standard | |
By HPLC | The retention time of the principal peak should correspond to that of the official standard | |
4 | Melting Range | 248°C to 252°C |
5 | Loss on Drying | Not more than 0.50% w/w |
6 | Residue on Ignition | Not more than 0.10% w/w |
7 | Heavy Metals | Not more than 10 ppm |
8 | Related Substances by HPLC | |
Single Maximum Impurity | Not more than 0.50% | |
Total Impurities | Not more than 1.00% |
Packing and Storage condition of Minoxidil
Pack Minoxidil in a clear poly bag and twist the mouth of the bag. Secure it with a PVC strip. Place this bag inside another poly bag, twist its mouth, and secure it with a PVC strip. Insert these bags into a triple-laminated aluminum bag and seal it properly. Finally, place the sealed aluminum bag in an HDPE container. Store Minoxidil in a tightly closed, light-resistant container at a temperature below 30°C.
MSDS - Minoxidil
Why Choose Chemignition for
Minoxidil Supply?
Quality Assurance
Grade Compliance
Minoxidil is manufactured in adherence to stringent global pharmaceutical standards.
In-House Quality Control
Each batch undergoes rigorous testing for purity, stability, and efficacy.
Regulatory Approvals
Certified for export and compliant with international regulatory requirements.
Large-Scale Manufacturing and Export
Grade Compliance
Minoxidil is manufactured in adherence to stringent global pharmaceutical standards.
In-House Quality Control
Each batch undergoes rigorous testing for purity, stability, and efficacy.
Regulatory Approvals
Certified for export and compliant with international regulatory requirements.