Buy EP8 Antihistaminic APIs Azelastine Hydrochloride (Astelin) Powder Online
What is Azelastine Hydrochloride(Astelin)?
Azelastine is a potent, second-generation, selective, histamine antagonist (histamine-H1-receptor antagonist) used as a first line therapy of mild intermittent, moderate/severe intermittent and mild persistent rhinitis (new classification system for rhinitis).
Azelastine has been formulated both as a nasal spray and as eye drops and are available worldwide under many brand names.
Azelastine Hydrochloride Basic Information
Product Name: Azelastine hydrochloride
Synonyms: a5610;azeptin;e-0659;w-2979m;AZELASTINE HCL;AZELASTINE HYDROCHLORIDE;4-[(4-chlorophenyl)methyl]-2-(1-methylazepan-4-yl)-phthalazin-1-one hydrochloride;4-[(4-Chlorophenyl)methyl]-2-(hexahydro-1-methyl-1H-azepin-4-yl)-1(2H)-phthalazinone Hydrochloride
CAS: 79307-93-0
W F: C22H25Cl2N3O
M W: 418.36
Product Categories: Antihistaminic;Intermediates & Fine Chemicals;Pharmaceuticals;Histamine receptor;Astelin
Melting point 225–229ºC
Storage temp. : Keep in room temperature .
Stability: Incompatible with strong oxidizing agents.
Chemical Properties White Crystalline Powder
Usage Orally active H1-hystamine receptor antagonist. Antihistaminic .
Azelastine Hydrochloride Certificate Of Analysis
| Product name |
Azelastine Hydrochloride |
| CAS No. |
153408-27-6;
153408-28-7;79307-93-0 |
Outer Packing |
25kg/drum |
| Production date |
15th Jan 2018 |
Shelf life |
14th Jan 2021 |
| Standard adopted |
EP8.0 |
| Items of analysis |
Specification |
Results |
| Appearance |
White or almost white, crystalline powder |
Almost white, crystalline powder |
| Solubility |
Sparingly soluble in water, soluble in ethanol and in methylene chloride |
Sparingly soluble in water, soluble in ethanol and in methylene chloride |
| Identification |
(A)By IR absorption, To match with working standard；(B) 1% Solution gives reaction of chlorides |
Positive |
| Appearance of solution |
Clear and colorless |
Clear and colorless |
| Acidity or alkalinity |
Not more than 0.1 ml of 0.01 mol/L hydrochloric acid or 0.01mol/L sodium hydroxide |
Conforms |
| Impur: A、B、C、D and E |
max, 0.1% |
max, 0.05% |
| Any other impur |
max,0.1% |
max,0.05% |
| Total impur |
max,0.2% |
max,0.10% |
| Disregard limit |
0.05% |
0.02% |
| Loss on drying |
≤0.5% |
0.26% |
| Assay |
99.0%~101.0% |
99.60% |
| Conclusion |
Qualified |
Azelastine Side effects
Azelastine is safe and well tolerated in both adults and children with allergic rhinitis.[7][8][9] Bitter taste, headache, nasal burning and somnolence are the most frequently reported adverse events. US prescribing recommendations warn against the concurrent use of alcohol and/or other central nervous system depressants,
