Carglumic Acid impurity 03 CAS 196394-48-6
| CAS No. | 196394-48-6 |
| Molecular Formula | C12H19NO5 |
| Molecular Weight | 257.28 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 Carglumic Acid impurity 03.
Carglumic Acid impurity 03 (CAS 196394-48-6) is a certified pharmaceutical impurity reference standard with the molecular formula C12H19NO5 and a molecular weight of 257.28 g/mol.
The molecular framework of Carglumic Acid impurity 03 (C12H19NO5) is characterized by an amino-acid-derived structure, an amide group, a hydroxyl group, an ether linkage. In reversed-phase chromatography, its retention is governed primarily by the protonation state of its nitrogen-containing groups, which provides a practical basis for HPLC-UV/DAD or LC-MS method development. The aromatic system may exhibit native fluorescence, enabling detection with a fluorescence detector (FLD).
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 | C12H19NO5 |
| Molecular Weight | 257.28 g/mol |
| Appearance | Off-white to pale yellow crystalline powder |
| Purity | 97%+ |
| Storage | Store at 2-8°C, protect from light, keep sealed and dry |
| Solubility (reference) | Soluble in methanol, acetonitrile, DMSO, water (slightly soluble) |
| Stability | May oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light; Hygroscopic; reseal immediately after opening |
| Degree of Unsaturation (DBE) | 4.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 2013 |
| Nitrogen Atoms | 1 |
Related Carglumic Standards
- Carglumic Acid impurity 02 (CAS 196394-49-7)
- Carglumic Acid impurity 10 (CAS 862672-48-8)
- Carglumic Acid impurity 8 (CAS 45214-91-3)
- Carglumic Acid Impurity 14 (CAS CATO-C4X-207914)
- Carglumic Acid impurity 13 (CAS 2842007-45-6)
- Carglumic Acid Impurity 2 (CAS CATO-C4X-20792)
- Carglumic Acid Impurity 5 (CAS CATO-C4X-20795)
- Carglumic Acid impurity 7 (CAS 219844-08-3)
Recommended Standards
- 4-(Tert-butoxycarbonyl)hexahydro-2H-furo[3,2-b]pyrrole-6-carboxylic acid (CAS 1936631-17-2)
- (1S,3S,4S)-7-(tert-butoxycarbonyl)-3-hydroxy-7-azabicyclo[2.2.1]Heptane-1-carboxylic acid (CAS 1932805-40-7)
- Diethyl 5-oxoazepane-1,4-dicarboxylate (CAS 19786-58-4)
- (1R,3R,4R)-7-(tert-butoxycarbonyl)-3-hydroxy-7-azabicyclo[2.2.1]Heptane-1-carboxylic acid (CAS 1932794-67-6)
- Nemonoxacin Impurity 27 (CAS 926279-65-4)
- Alogliptin Impurity 25 (CAS CATO-C4X-109925)
- Pyridoxine impurity 88 (CAS CATO-C4X-187788)
- 3-(3-Fluorobenzoyl)-1h-pyrrole (CAS 893612-64-1)
- 2-chloro-6-[2-(trifluoromethoxy)phenyl]pyridine (CAS 1261856-69-2)
- 4-(3-Methylisoxazole-5-carboxamido)benzoic acid (CAS 62536-28-1)
- Methyl 6-methoxy-1H-1,3-benzodiazole-2-carboxylate (CAS 1016163-41-9)
- 5-(2-(Methylthio)phenyl)-1,2,4-oxadiazole-3-carboxylic acid (CAS 1502039-45-3)
- 5-Chloro-2-(2-(2-((3-(furan-3-yl)phenyl)amino)-2-oxoethoxy)acetamido)benzoic acid (CAS 1190221-43-2)
- Semaglutide Impurity 184 (CAS CATO-C4X-2226184)
Why CATO?
- ISO 17034 accredited reference material producer (CNAS + ANAB dual accreditation)
- 130,000+ catalog items in stock, COA supplied with every batch
- Worldwide shipping with full export documentation (HS code guidance available)
- Technical support: +86 18665070610 / Nicole.chen@cato-chem.com