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Epinastine EP Impurity B

EP impurity reference standard

CAS1217052-16-8
Epinastine EP Impurity B chemical structure
Cat. no. C4X-18407 Purity >95% HPLC Form Yellow Powder

Specifications

Product name
Epinastine EP Impurity B
CAS number
1217052-16-8
Catalogue number
C4X-18407
Molecular formula
C16H14BrN3
Molecular weight
328.21
Purity (HPLC)
>95%
Physical form
Yellow Powder
Storage
2-8 °C
SMILES
N12C(N)=NCC1C1C=CC=CC=1CC1C=C(Br)C=CC2=1
Available pack sizes
Quoted on request
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

Epinastine EP Impurity B (CAS 1217052-16-8) is supplied by ImpurityLab as a European Pharmacopoeia impurity standard, identified by letter against the monograph for its parent substance. Catalogue number C4X-18407.

The material is issued against molecular formula C16H14BrN3, molecular weight 328.21 g mol−1, physical form described as yellow powder.

Structural notation: N12C(N)=NCC1C1C=CC=CC=1CC1C=C(Br)C=CC2=1

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. Quoted on request. 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-18407 when requesting either document.

Documentation

Certificate of analysis (per lot)COA-C4X-18407Download
Safety data sheet (SDS)SDS-C4X-18407Download

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

Regulatory reference

EP Impurity B. 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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