PHR1636

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
• Empirical Formula (Hill Notation): C₂₂H₂₄ClN₃O · HCl
• CAS Number: 79307-93-0
• Molecular Weight: 418.36
• MDL number: MFCD00242783
• UNSPSC Code: 41116107
• PubChem Substance ID: 329823526
• NACRES: NA.24

Properties

• grade: certified reference material; pharmaceutical secondary standard
• Quality Level: 300
• 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)

Description

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.

Safety Information

• pictograms: GHS07
• signalword: Warning
• hcodes: H302
• pcodes: P264 - P270 - P301 + P312 - P501
• Hazard Classifications: Acute Tox. 4 Oral
• Storage Class: 11 - Combustible Solids
• wgk_germany: WGK 3
• flash_point_f: Not applicable
• flash_point_c: Not applicable