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Merck
CN

Y0000326

Azelastine hydrochloride

European Pharmacopoeia (EP) Reference Standard

Synonym(s):

4-[(4-chlorophenyl)methyl]-2-(1-methylazepan-4-yl)phthalazin-1-one hydrochloride, Astelin, Optivar

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About This Item

Empirical Formula (Hill Notation):
C22H24ClN3O · HCl
CAS Number:
Molecular Weight:
418.36
NACRES:
NA.24
PubChem Substance ID:
UNSPSC Code:
41116107
MDL number:
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InChI

1S/C22H24ClN3O.ClH/c1-25-13-4-5-18(12-14-25)26-22(27)20-7-3-2-6-19(20)21(24-26)15-16-8-10-17(23)11-9-16;/h2-3,6-11,18H,4-5,12-15H2,1H3;1H

SMILES string

Cl.CN1CCCC(CC1)N2N=C(Cc3ccc(Cl)cc3)c4ccccc4C2=O

InChI key

YEJAJYAHJQIWNU-UHFFFAOYSA-N

grade

pharmaceutical primary standard

API family

azelastine

manufacturer/tradename

EDQM

application(s)

pharmaceutical (small molecule)

format

neat

storage temp.

2-8°C

Gene Information

human ... HRH1(3269)

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General description

This product is provided as delivered and specified by the issuing Pharmacopoeia. All information provided in support of this product, including SDS and any product information leaflets have been developed and issued under the Authority of the Issuing Pharmacopoeia. For further information and support please go to the website of the issuing Pharmacopoeia.

Application

Azelastine hydrochloride EP Reference standard, intended for use in laboratory tests only as specifically prescribed in the European Pharmacopoeia.

Biochem/physiol Actions

H1 histamine receptor antagonist; NF-kB activator.

Packaging

The product is delivered as supplied by the issuing Pharmacopoeia. For the current unit quantity, please visit the EDQM reference substance catalogue.

Other Notes

Sales restrictions may apply.

pictograms

Exclamation mark

signalword

Warning

hcodes

Hazard Classifications

Acute Tox. 4 Oral

Storage Class

11 - Combustible Solids

flash_point_f

Not applicable

flash_point_c

Not applicable


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Certificates of Analysis (COA)

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Jonathan A Bernstein
Current medical research and opinion, 23(10), 2441-2452 (2007-08-29)
Azelastine hydrochloride (Astelin) nasal spray 0.1% solution is a second-generation intranasal antihistamine available in the US for treatment of both seasonal allergic rhinitis (SAR) and nonallergic vasomotor rhinitis (VMR). Searches of journal articles including the title word 'azelastine' from 1979
Hartmut Derendorf et al.
British journal of clinical pharmacology, 74(1), 125-133 (2012-02-24)
• The topical second generation anti-histamine azelastine hydrochloride (AZE) and the potent corticosteroid fluticasone propionate (FP) are well established first-line treatments in allergic rhinitis (AR). • MP29-02, a novel intranasal AZE and FP formulation, has been shown to control AR
Daniel Baumann et al.
European journal of pharmaceutics and biopharmaceutics : official journal of Arbeitsgemeinschaft fur Pharmazeutische Verfahrenstechnik e.V, 80(1), 156-163 (2011-09-29)
For locally acting drugs, an extended residence time in the nasal cavity is desirable and related to a prolonged effect. We sought to develop a model for comparative determination of intranasal pharmacokinetics. We embedded human respiratory tissue into a solid
Alisa Rudnitskaya et al.
Analytica chimica acta, 770, 45-52 (2013-03-19)
The application of the potentiometric multisensor system (electronic tongue, ET) for quantification of the bitter taste of structurally diverse active pharmaceutical ingredients (API) is reported. The measurements were performed using a set of bitter substances that had been assessed by
Warner W Carr et al.
Allergy and asthma proceedings, 33(6), 450-458 (2012-11-07)
Intranasal corticosteroids are considered the most effective therapy for moderate-to-severe seasonal allergic rhinitis (SAR) and recommended first line in guidelines. It is uncertain whether intranasal antihistamines have comparable efficacy. This study was designed to compare the efficacy of azelastine (AZE;

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