Key Properties of Oxymetazoline Hydrochloride
| Product Name: | Oxymetazoline Hydrochloride |
| Synonyms: | 6-tert-butyl-3-(4,5-dihydro-1H-imidazol-2-ylmethyl)-2,4-dimethylphenol;hydrochloride |
| CAS No: | 2315-02-08 |
| Chemical Formula: | C16H24N2O.ClH |
| Grade: | IP/BP/USP |
| Appearance | White to off-white Solid powder |
| Molar Mass: | 296.83 g/mol |
| Solubility: | Soluble in water and alcohol |
Inquiry
Whatsapp
Download
BroucherManufacturing process of Oxymetazoline Hydrochloride
The manufacturing of Oxymetazoline Hydrochloride begins by verifying the cleanliness of equipment and ensuring the availability of all utilities, raw materials, and packing materials.
Charge the industrial solvent in glass line reactor (GLR) and gradually add oxymetazoline base and hydrochloric acid. Stir the reaction mass for 10-15 minutes. Maintain the reaction mass at 30–40°C for 240–360 minutes.
Take the in-process sample from reactor and send the in-process sample to quality control (QC) for reaction monitoring by TLC. After result complies centrifugation operation to be carried out. and Final wet cake dry under vacuum at 40–50°C for 240-480 minutes.
Finally, Pack Oxymetazoline Hydrochloride 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 Oxymetazoline Hydrochloride in a tightly closed, light-resistant container at a temperature below 30°C.
Applications of Oxymetazoline Hydrochloride
Technical Specifications of Oxymetazoline Hydrochloride
| Sr.No. | Test | Specification |
|---|---|---|
| 1 | Description | White to off-white crystalline powder |
| 2 | Identification | A) Infrared (IR) spectroscopy: The IR spectrum of the sample should match that of the reference standard. B) Ultraviolet (UV) absorption: Absorptivities at 279 nm, calculated on the dried basis, do not differ by more than 3.0%. |
| 3 | Assay (Content of Oxymetazoline Hydrochloride) | 98.5% to 101.5% (calculated on the dried basis) |
| 4 | pH | Between 4.0 and 6.5 (in a 1 in 20 solution) |
| 5 | Loss on Drying | Not more than 1.0% (when dried at 105°C for 3 hours) |
| 6 | Residue on Ignition | Not more than 0.1% |
| 7 | Heavy Metals | Not more than 10 ppm |
| 8 | Related Substances (by HPLC) | – Individual unspecified impurity: Not more than 0.1% – Total impurities: Not more than 0.5% |
| 9 | Residual Solvents (by GC) | – Methanol: Not more than 3000 ppm – Ethanol: Not more than 5000 ppm – Dichloromethane: Not more than 600 ppm – Acetone: Not more than 5000 ppm |
Packing and Storage condition of Oxymetazoline Hydrochloride
Pack Oxymetazoline Hydrochloride 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 Oxymetazoline Hydrochloride in a tightly closed, light-resistant container at a temperature below 30°C.
Why Choose Chemignition for
Oxymetazoline Hydrochloride Supply?
Quality Assurance
Grade Compliance
Oxymetazoline Hydrochloride 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
Oxymetazoline Hydrochloride 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.
