Key Properties of Azelastine Hydrochloride
| Product Name: | Azelastine hydrochloride |
| Synonyms: | (RS)-1-(2H)-Phthalazinone, 4-[(4-chlorophenyl)methyl]-2-(hexahydro-1-methyl-1H-azepin-4-ylidene)-, monohydrochloride. |
| CAS No: | 79307-93-0 |
| Chemical Formula: | C22H24ClN3O |
| Grade: | BP/USP |
| Appearance: | Crystalline powder |
| Molar Mass: | 381.90 g/mol |
| Solubility: | Soluble in water and methanol; slightly soluble in ethanol; insoluble in acetone and ether. |
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BroucherManufacturing process of Azelastine Hydrochloride
The manufacturing process begins with ensuring equipment cleanliness and availability of utilities, raw materials, and packing materials.
Charge methanol or ethanol is into a glass-lined reactor (GLR), further gradually add Azelastine base and hydrochloric acid in reactor under continuous stirring. Maintain the reaction mass temperature at 25–30°C for 120–180 minutes and record the detail.
Take the In-process sample from reactor and send the In-process sample to Quality control (QC) for reaction monitoring by HPLC. After In-process result complies cool the reaction mass up to 0–5°C and maintain the reaction mass for 60-120 minutes and record the detail.
Centrifugation operation perform for separation of solid product and washed wet cake with chilled solvent to remove impurities.
The wet cake is dried under vacuum at 50–60°C, milled to achieve uniform particle size, and sieved.
Pack Azelastine 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 Azelastine Hydrochloride in a tightly closed, light-resistant container at a temperature below 30°C.
Applications of Azelastine Hydrochloride
Technical Specifications of Azelastine Hydrochloride
| Sr.No. | Test | Specification |
|---|---|---|
| 1 | Description | A white or almost white, crystalline powder |
| 2 | Solubility | Soluble in ethanol and in dichloromethane; sparingly soluble in water |
| 3 | Identification by IR Spectroscopy | The IR spectrum obtained with the test sample should be concordant with the working standard |
| 4 | Acidity or Alkalinity | Not more than 0.1 ml of 0.01 M hydrochloric acid or 0.01 M sodium hydroxide is required to change the colour of the solution |
| 5 | Loss on Drying | NMT 1.0% |
| 6 | Residue on Ignition | NMT 0.2% |
| 7 | Related Substance by Organic Impurity | Any Impurity: NMT 0.1% Total Impurities: NMT 0.2% |
| 8 | Assay | 99.0% to 101.0% |
| 9 | Residual Solvents by GC | Ethanol: NMT 5000 ppm Acetone: NMT 5000 ppm Isopropyl Alcohol: NMT 5000 ppm Methanol: NMT 3000 ppm Methylene Chloride: NMT 600 ppm Toluene: NMT 890 ppm |
| 10 | Particle Size | D90 < 10 Microns |
Packing and Storage condition of Azelastine Hydrochloride
Pack Azelastine 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 Azelastine Hydrochloride in a tightly closed, light-resistant container at a temperature below 30°C.
Why Choose Chemignition for
Azelastine Hydrochloride Supply?
Quality Assurance
Grade Compliance
Azelastine 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
Azelastine 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.
