Pemafibrate Impurity 35 CAS CATO-C4X-290335
| CAS No. | CATO-C4X-290335 |
| Molecular Formula | C8H13F3O5S |
| Molecular Weight | 278.25 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
Under current pharmacopoeial and regulatory frameworks, quality-control requirements for this class of reference material explicitly involve the control of targets including Pemafibrate Impurity 35.
CATO supplies Pemafibrate Impurity 35 (CAS CATO-C4X-290335), a pharmacopoeial impurity reference standard (molecular formula C8H13F3O5S, MW 278.25 g/mol) used for the identification and quantification of trace impurities in APIs.
The molecular framework of Pemafibrate Impurity 35 (C8H13F3O5S) is characterized by a sulfone group, a carboxylic acid group, a hydroxyl group, an ether linkage, fluorine substitution. In reversed-phase chromatography, its retention is governed primarily by the polarity and ionization state of its functional groups, which provides a practical basis for HPLC-UV/DAD or LC-MS method development. Halogen substitution (F/Cl/Br/I) produces a distinctive isotope pattern in mass spectrometry, a valuable aid for qualitative confirmation.
This reference standard supports related-substances testing and method development in line with ICH Q3A/Q3B guidance on impurity control, and is suitable for system suitability testing and forced-degradation studies.
The assigned purity is verified by mass-balance and quantitative NMR (qNMR) approaches, with the expanded uncertainty reported at a 95% confidence level (k=2). Batch homogeneity and stability are independently assessed for every lot.
Physical & Chemical Properties
| Molecular Formula | C8H13F3O5S |
| Molecular Weight | 278.25 g/mol |
| Purity | 97%+ |
| Storage | Store in a cool place (≤25°C), keep sealed and dry, keep tightly closed to prevent evaporation |
| Solubility (reference) | Soluble in methanol, ethanol, DMSO |
| Stability | Hygroscopic; reseal immediately after opening; Contains ester bond; hydrolyzes under strong alkaline conditions |
| Degree of Unsaturation (DBE) | 1.0 |
| Halogen Content | F-containing |
| Sulfur Atoms | 1 |
Related Pemafibrate Standards
- Pemafibrate Impurity 40 (CAS CATO-C4X-290340)
- Pemafibrate Impurity 31 (CAS CATO-C4X-290331)
- Pemafibrate Impurity 8 (CAS CATO-C4X-29038)
- Pemafibrate Impurity 100 (CAS CATO-C4X-2903100)
- Pemafibrate Impurity 101 (CAS CATO-C4X-2903101)
- Pemafibrate Impurity 4 (CAS 907192-58-9)
- Pemafibrate Impurity 59 (CAS CATO-C4X-290359)
- Pemafibrate Impurity 60 (CAS CATO-C4X-290360)
Recommended Standards
- N-(5-amino-2-fluorophenyl)-2-(3-fluorophenoxy)acetamide (CAS 953754-32-0)
- 1-[(2,6-dimethoxyphenoxy)methyl]-1h-pyrazole-3-carboxylic acid (CAS 1001519-23-8)
- N-(3-Amino-4-fluorophenyl)-2-(3-fluorophenoxy)-acetamide (CAS 954263-27-5)
- (2Z)-2-[(Z)-Benzoyl]-3-(4-nitrophenyl)prop-2-enenitrile (CAS 101220-38-6)
- Pemafibrate Impurity 98 (CAS CATO-C4X-290398)
- Pimavanserin Impurity 2 (CAS 103907-97-7)
- Carteolol Impurity 15 (CAS CATO-C4X-228715)
- Opicapone impurity 20 (CAS 2824922-36-1)
- 9-Chloro-9-(4-(hexyloxy)phenyl)-10-methyl-9,10-dihydroacridine (CAS 509-94-4)
- Cyclohexyl 3-(2-fluorophenyl)-3-(phenylsulfonyl)propanoate (CAS 2376300-31-9)
- 4-(Cyclopentylsulfanyl)-3-fluoroaniline (CAS 1095666-71-9)
- 1-(3-hydroxypropyl)cyclobutan-1-ol (CAS 1584139-24-1)
- 1-Bromo-4-iodoisoquinoline (CAS 1823904-45-5)
- Semaglutide impurity 42 (CAS CATO-C4X-222642)
Why CATO?
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- 130,000+ catalog items in stock, COA supplied with every batch
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- Technical support: +86 18665070610 / Nicole.chen@cato-chem.com