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Fluconazole EP Impurity A

EP impurity reference standard

CAS89429-59-4
Fluconazole EP Impurity A chemical structure
Cat. no. C4X-10194 Purity >95% HPLC Form White Powder

Specifications

Product name
Fluconazole EP Impurity A
CAS number
89429-59-4
Catalogue number
C4X-10194
Molecular formula
C13H12F2N6O
Molecular weight
306.27
Purity (HPLC)
>95%
Physical form
White Powder
Storage
2-8 °C
SMILES
C1(F)C=C(F)C(C(CN2N=CN=C2)(CN2C=NN=C2)O)=CC=1
Available pack sizes
300 mg / 100 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

Fluconazole EP Impurity A (CAS 89429-59-4) is supplied by ImpurityLab as a European Pharmacopoeia impurity standard, identified by letter against the monograph for its parent substance. Catalogue number C4X-10194. It is related to Fluconazole.

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

The material is issued against molecular formula C13H12F2N6O, molecular weight 306.27 g mol−1, physical form described as white powder.

Structural notation: C1(F)C=C(F)C(C(CN2N=CN=C2)(CN2C=NN=C2)O)=CC=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. 300 mg / 100 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-10194 when requesting either document.

Documentation

Certificate of analysis (per lot)COA-C4X-10194Download
Safety data sheet (SDS)SDS-C4X-10194Download

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

Regulatory reference

EP Impurity A. 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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