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PHR1636

Supelco

Azelastine Hydrochloride

Pharmaceutical Secondary Standard; Certified Reference Material

Synonym(s):

Azelastine hydrochloride, 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
MDL number:
UNSPSC Code:
41116107
PubChem Substance ID:

grade

certified reference material
pharmaceutical secondary standard

Quality Level

Agency

traceable to Ph. Eur. Y0000326
traceable to USP 1046158

API family

azelastine

CofA

current certificate can be downloaded

packaging

pkg of 1 g

technique(s)

HPLC: suitable
gas chromatography (GC): suitable

application(s)

pharmaceutical (small molecule)

format

neat

storage temp.

2-30°C

SMILES string

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

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

InChI key

YEJAJYAHJQIWNU-UHFFFAOYSA-N

Gene Information

human ... HRH1(3269)

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General description

Certified pharmaceutical secondary standards for application in quality control provide pharma laboratories and manufacturers with a convenient and cost-effective alternative to the preparation of in-house working standards.
Azelastine Hydrochloride is a long-acting antiallergic and antiasthmatic drug.

Application

Azelastine Hydrochloride may be used as a pharmaceutical secondary reference standard for the determination of azelastine in plasma samples by manual-injection liquid chromatographic method using fluorescence detection.
These Secondary Standards are qualified as Certified Reference Materials. These are suitable for use in several analytical applications including but not limited to pharma release testing, pharma method development for qualitative and quantitative analyses, food and beverage quality control testing, and other calibration requirements.

Biochem/physiol Actions

H1 histamine receptor antagonist; NF-kB activator.

Analysis Note

These secondary standards offer multi-traceability to the USP, EP and BP primary standards, where they are available.

Other Notes

This Certified Reference Material (CRM) is produced and certified in accordance with ISO 17034 and ISO/IEC 17025. All information regarding the use of this CRM can be found on the certificate of analysis.

Footnote

To see an example of a Certificate of Analysis for this material enter LRAA5303 in the Documents slot below. This is an example certificate only and may not be the lot that you receive.

Pictograms

Exclamation mark

Signal Word

Warning

Hazard Statements

Precautionary Statements

Hazard Classifications

Acute Tox. 4 Oral

Storage Class Code

11 - Combustible Solids

WGK

WGK 3

Flash Point(F)

Not applicable

Flash Point(C)

Not applicable


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Determination of azelastine and desmethylazelastine in human plasma by high-performance liquid chromatography
Pivonka J, et al.
Journal of Chromatography. B, Biomedical Sciences and Applications, 420(7), 89-98 (1987)
Inhibition of leukotriene (SRS-A)-mediated acute lung anaphylaxis by azelastine in guinea pigs
Chand N, et al.
Allergy, 41(7), 473-478 (1986)

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