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Azelastine EP Impurity E

EP impurity reference standard

CAS20526-97-0
Azelastine EP Impurity E chemical structure
Cat. no. C4X-13965 Purity >95% HPLC Form White to Off-White Powder

Specifications

Product name
Azelastine EP Impurity E
CAS number
20526-97-0
Catalogue number
C4X-13965
Molecular formula
C15H9ClO2
Molecular weight
256.68
Purity (HPLC)
>95%
Physical form
White to Off-White Powder
Storage
2-8 °C
SMILES
C1(OC(=CC2C=CC(Cl)=CC=2)C2C=CC=CC1=2)=O
Available pack sizes
25 mg
Lead time
In stock
Intended use
Related substances and impurity testing, method development and validation, system suitability, QC release and stability testing.

Fields shown as — are not published for this item. They are left blank rather than filled with an estimate.

Description

Azelastine EP Impurity E (CAS 20526-97-0) is supplied by ImpurityLab as a European Pharmacopoeia impurity standard, identified by letter against the monograph for its parent substance. Catalogue number C4X-13965. It is related to Azelastine.

Parent drug substance. Azelastine. Browse the full Azelastine impurity and related compound standards held by ImpurityLab.

The material is issued against molecular formula C15H9ClO2, molecular weight 256.68 g mol−1, physical form described as white to off-white powder.

Structural notation: C1(OC(=CC2C=CC(Cl)=CC=2)C2C=CC=CC1=2)=O

Letter designations are assigned inside a monograph for one named substance. The same molecule can carry a different letter, or a different style of name, in another pharmacopoeia. Map the material from its structure — chemical name, formula and CAS — rather than from the letter alone.

Storage. Store at 2-8 °C. Allow the container to reach room temperature before opening so that moisture does not condense onto the material. Record the date of first opening on the label.

Pack sizes. 25 mg. Non-standard quantities are quoted on request, normally within two working days.

Documentation. Each lot is released with a certificate of analysis that states the assay method, the water content and the form as supplied. The safety data sheet is available with the same lot number. Quote catalogue number C4X-13965 when requesting either document.

Documentation

Certificate of analysis (per lot)COA-C4X-13965Download
Safety data sheet (SDS)SDS-C4X-13965Download

Documents are issued per lot. The COA you receive describes the lot that ships, not a representative sample.

Regulatory reference

EP Impurity E. Confirm the acceptance criterion, the reporting threshold and the edition of the monograph against your own method before use.

References are provided to help you map a standard to a pharmacopoeial method. Confirm the acceptance criteria against your own method before use.

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