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Azithromycin EP Impurity J

EP impurity reference standard

CAS117693-41-1
Azithromycin EP Impurity J chemical structure
Cat. no. C4X-100315 Purity >95% HPLC Form White Solid

Specifications

Product name
Azithromycin EP Impurity J
CAS number
117693-41-1
Catalogue number
C4X-100315
Molecular formula
C30H58N2O9
Molecular weight
590.79
Purity (HPLC)
>95%
Physical form
White Solid
Storage
2-8 °C
SMILES
[C@@]1(CN(C)[C@]([H])(C)[C@](O)([H])[C@](C)(O)[C@]([H])(OC(=O)[C@]([H])(C)[C@](O)([H])[C@]([H])(C)[C@](O[C@H]2C(O)[C@H](N(C)C)CC(C)O2)([H])[C@@](O)(C)C1)CC)([H])C
Available pack sizes
50 mg / 25 mg / 10 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

Azithromycin EP Impurity J (CAS 117693-41-1) is supplied by ImpurityLab as a European Pharmacopoeia impurity standard, identified by letter against the monograph for its parent substance. Catalogue number C4X-100315. It is related to Azithromycin.

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

The material is issued against molecular formula C30H58N2O9, molecular weight 590.79 g mol−1, physical form described as white solid.

Structural notation: [C@@]1(CN(C)[C@]([H])(C)[C@](O)([H])[C@](C)(O)[C@]([H])(OC(=O)[C@]([H])(C)[C@](O)([H])[C@]([H])(C)[C@](O[C@H]2C(O)[C@H](N(C)C)CC(C)O2)([H])[C@@](O)(C)C1)CC)([H])C

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. 50 mg / 25 mg / 10 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-100315 when requesting either document.

Documentation

Certificate of analysis (per lot)COA-C4X-100315Download
Safety data sheet (SDS)SDS-C4X-100315Download

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

Regulatory reference

EP Impurity J. 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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