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Ranitidine EP Impurity J

EP impurity reference standard

CAS1331637-48-9
Ranitidine EP Impurity J chemical structure
Cat. no. C4X-137010 Purity >95% HPLC Form Off-White to Pale Yellow Solid

Specifications

Product name
Ranitidine EP Impurity J
CAS number
1331637-48-9
Catalogue number
C4X-137010
Molecular formula
C11H22N6O4S2
Molecular weight
366.46
Purity (HPLC)
>95%
Physical form
Off-White to Pale Yellow Solid
Storage
-20 °C ± 5 °C
SMILES
CN/C(=C/[N+]([O-])=O)/NCCSCSCCN/C(=C\[N+]([O-])=O)/NC
Available pack sizes
750 mg / 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

Ranitidine EP Impurity J (CAS 1331637-48-9) is supplied by ImpurityLab as a European Pharmacopoeia impurity standard, identified by letter against the monograph for its parent substance. Catalogue number C4X-137010. It is related to Ranitidine.

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

The material is issued against molecular formula C11H22N6O4S2, molecular weight 366.46 g mol−1, physical form described as off-white to pale yellow solid.

Structural notation: CN/C(=C/[N+]([O-])=O)/NCCSCSCCN/C(=C\[N+]([O-])=O)/NC

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 -20 °C ± 5 °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. 750 mg / 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-137010 when requesting either document.

Documentation

Certificate of analysis (per lot)COA-C4X-137010Download
Safety data sheet (SDS)SDS-C4X-137010Download

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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