Dronedarone Impurity 3
process impurity reference standard
Specifications
- Product name
- Dronedarone Impurity 3
- CAS number
- 141645-16-1
- Catalogue number
C4X-10923- Molecular formula
- C19H17NO5
- Molecular weight
- 339.34
- Purity (HPLC)
- >95%
- Physical form
- White to Off-White Solid
- Storage
- 2-8 °C
- SMILES
C1C=C2OC(CCCC)=C(C(=O)C3C=CC(O)=CC=3)C2=CC=1[N+](=O)[O-]- Available pack sizes
- 50 mg / 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
Dronedarone Impurity 3 (CAS 141645-16-1) is supplied by ImpurityLab as a process impurity standard, covering impurities that are neither pharmacopoeially lettered nor degradation products of the parent substance. Catalogue number C4X-10923. It is related to Dronedarone.
Parent drug substance. Dronedarone. Browse the full Dronedarone impurity and related compound standards held by ImpurityLab.
The material is issued against molecular formula C19H17NO5, molecular weight 339.34 g mol−1, physical form described as white to off-white solid.
Structural notation: C1C=C2OC(CCCC)=C(C(=O)C3C=CC(O)=CC=3)C2=CC=1[N+](=O)[O-]
Process impurities are controlled through the ICH Q3A reporting, identification and qualification thresholds, or through the equivalent thresholds in ICH Q3B for the drug product. The limits depend on the maximum daily dose of the product rather than on the impurity itself.
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. 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-10923 when requesting either document.
Documentation
Documents are issued per lot. The COA you receive describes the lot that ships, not a representative sample.
Regulatory reference
Process impurity, not pharmacopoeially lettered. Set the limit from your own ICH Q3A or Q3B assessment and confirm against the current method.
References are provided to help you map a standard to a pharmacopoeial method. Confirm the acceptance criteria against your own method before use.