Bedaquiline fumarate light degradation impurity
degradation product reference standard
Specifications
- Product name
- Bedaquiline fumarate light degradation impurity
- CAS number
- Catalogue number
B119525- Molecular formula
- C36 H34 N2 O6
- Molecular weight
- 590.66
- Purity (HPLC)
- Physical form
- No Data Available
- Storage
- SMILES
COc1nc2ccc(cc2cc1[C@@H](c3ccccc3)[C@@](O)(CCN(C)C)c4cccc5ccccc45)\C(=C/C(=O)O)\C(=O)O- 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; forced degradation and stability-indicating methods.
Fields shown as — are not published for this item. They are left blank rather than filled with an estimate.
Description
Bedaquiline fumarate light degradation impurity is supplied by ImpurityLab as a degradation product standard, used to characterise the impurities that form when the parent substance is stressed or stored. Catalogue number B119525.
The material is issued against molecular formula C36 H34 N2 O6, molecular weight 590.66 g mol−1, physical form described as no data available.
Structural notation: COc1nc2ccc(cc2cc1[C@@H](c3ccccc3)[C@@](O)(CCN(C)C)c4cccc5ccccc45)\C(=C/C(=O)O)\C(=O)O
Reported solubility: No Data Available
A degradation product is judged against a stability-indicating method rather than against a monograph letter. The standard is used to establish where the peak falls, to confirm its identity in stressed samples, and to set a limit that your own stability data can support.
Storage. Store at as specified on the certificate of analysis. 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 B119525 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
Degradation product. Used to characterise stress and stability samples; set the acceptance criterion from your own stability-indicating method.
References are provided to help you map a standard to a pharmacopoeial method. Confirm the acceptance criteria against your own method before use.