Sitafloxacin Impurity 43 CAS 127199-16-0
| CAS No. | 127199-16-0 |
| Molecular Formula | C8H14FNO2 |
| Molecular Weight | 175.20 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 Sitafloxacin Impurity 43.
Sitafloxacin Impurity 43 (CAS 127199-16-0) is a certified pharmaceutical impurity reference standard with the molecular formula C8H14FNO2 and a molecular weight of 175.20 g/mol.
Structurally, Sitafloxacin Impurity 43 (C8H14FNO2) contains an amide group, a carboxylic acid group, a hydroxyl group, an ether linkage, fluorine substitution. The molecule exhibits a degree of unsaturation (DBE) of 2.0, corresponding to approximately 2 ring(s) or double-bond equivalent(s). With a molecular weight of 175.20 g/mol, it falls into the medium-molecular-weight range. 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 | C8H14FNO2 |
| Molecular Weight | 175.20 g/mol |
| Purity | >95% |
| Storage | Store at 2-8°C, protect from light, keep tightly closed to prevent evaporation |
| Solubility (reference) | Soluble in methanol, acetonitrile, DMSO, water (slightly soluble) |
| Stability | Light-sensitive; avoid direct strong light; Contains ester bond; hydrolyzes under strong alkaline conditions |
| Degree of Unsaturation (DBE) | 2.0 |
| CAS Registry Year (est.) | 1993 |
| Halogen Content | F-containing |
| Nitrogen Atoms | 1 |
Related Sitafloxacin Standards
- Sitafloxacin Impurity 25 (CAS 105919-35-5)
- Sitafloxacin Impurity 23 (CAS 127199-15-9)
- Sitafloxacin Impurity 27 (CAS 119385-80-7)
- Sitafloxacin Impurity 40 (CAS 144282-35-9)
- Sitafloxacin impurity 84 (CAS 1533823-99-2)
- (7R)-Sitafloxacin Impurity 13 (CAS 127199-44-4)
- (7S)-Sitafloxacin Impurity N11 (CAS 127199-45-5)
- Sitafloxacin impurity 53 (CAS 1933694-45-1)
Recommended Standards
- Vonoprazan Impurity 216 (CAS 1428932-17-5)
- 5-(2-Thienyl)-1H-pyrazole-4-carbonitrile (CAS 1008428-30-5)
- ( inverted exclamation markA)-amino(2-fluorophenyl)acetic acid (1)-amino(2-fluorophenyl)acetic acid 2-(o-fluorophenyl)glycine 2-fluoro-dl-|A-phenylglycine 84145-28-8 Amino-(2-fluoro-phenyl)-acetic acid benzeneacetic acid, a-amino-2-fluoro- einecs 282-253-9 (CAS 84145-28-8)
- 3-Ethoxy-2-(methylsulfonyl)acrylonitrile (CAS 104007-26-3)
- Brexpiprazole Impurity 24 (CAS 2809183-06-8)
- Iobitridol Impurity 23 (CAS CATO-C4X-317823)
- Haloperidol EP Impurity D (CAS 67987-08-0)
- 5-ethoxy-1,3-benzothiazol-2-amine (CAS 70066-70-5)
- 3-(Difluoromethyl)imidazo[1,2-a]pyridin-8-ol (CAS 2091580-80-0)
- (R)-2-((((9H-Fluoren-9-yl)methoxy)carbonyl)amino)-7-azido-2-methylheptanoic acid (CAS 1191429-12-5)
- 1-Amino-n,n-diethylcyclohexane-1-carboxamide (CAS 1016782-22-1)
- 2-(Chloromethoxy)-1,1-difluoroethane (CAS 1558385-27-5)
- Decitabine Impurity 5 (CAS CATO-C4X-11375)
- Semaglutide impurity 94 (CAS CATO-C4X-222694)
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