Ambroxol Impurity 81 CAS CATO-C4X-108581
| CAS No. | CATO-C4X-108581 |
| Molecular Formula | C13H16N2O3 |
| Molecular Weight | 248.28 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 Ambroxol Impurity 81.
CATO supplies Ambroxol Impurity 81 (CAS CATO-C4X-108581), a pharmacopoeial impurity reference standard (molecular formula C13H16N2O3, MW 248.28 g/mol) used for the identification and quantification of trace impurities in APIs.
Structurally, Ambroxol Impurity 81 (C13H16N2O3) contains a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage. The molecule exhibits a degree of unsaturation (DBE) of 7.0, corresponding to approximately 7 ring(s) or double-bond equivalent(s). With a molecular weight of 248.28 g/mol, it falls into the medium-molecular-weight range. Nitrogen-containing functional groups confer excellent ionization efficiency in positive-ion electrospray (ESI) mode, making the compound well suited to LC-MS/MS analysis.
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 | C13H16N2O3 |
| Molecular Weight | 248.28 g/mol |
| Appearance | Off-white to pale yellow crystalline powder |
| Purity | >95% |
| Storage | Store at 2-8°C, protect from light, keep sealed and dry |
| Solubility (reference) | Soluble in DMSO, DMF, methanol |
| Stability | May oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light; Hygroscopic; reseal immediately after opening |
| Degree of Unsaturation (DBE) | 7.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| Nitrogen Atoms | 2 |
Related Ambroxol Standards
- Ambroxol Impurity 100 (CAS 1631131-54-8)
- Ambroxol Impurity 18 (CAS 953039-29-7)
- Ambroxol Impurity 7 (CAS 15942-11-7)
- Ambroxol impurity 61 (CAS 104670-74-8)
- Ambroxol Impurity 44 (CAS 882772-99-8)
- Ambroxol Impurity N1 (CAS 46727-91-7)
- Ambroxol Impurity 84 (CAS CATO-C4X-108584)
- Ambroxol impurity 116 (CAS 1373889-89-4)
Recommended Standards
- N,3-Dimethyl-2-oxo-N-(phenylmethyl)-4-oxazolidinecarboxamide (CAS 1323087-06-4)
- Procaterol Impurity 40 (CAS 63483-95-4)
- (R)-2-((S)-1-Nitrosopiperidin-2-yl)-2-phenylacetic Acid (CAS 24321-27-5)
- Torasemide impurity 31 (CAS CATO-C4X-183631)
- Mianserin EP Impurity E HCl (CAS 76134-77-5)
- Ozenoxacin Impurity 67 (CAS CATO-C4X-279667)
- Probucol Impurity 17 (CAS 1195639-22-5)
- Sorafenib Impurity 57 (CAS 99970-10-2)
- (5-Cyano-3-cyclopropyl-2-methylphenyl)boronic acid (CAS 2225169-95-7)
- 3-(Pyridin-2-yl)pyrazolo[1,5-a]pyrimidine-6-carbaldehyde (CAS 1035818-92-8)
- 1-(((2-Aminoethyl)amino)methyl)cyclopentan-1-ol (CAS 1479221-60-7)
- 4-(4,4,5,5-Tetramethyl-1,3,2-dioxaborolan-2-yl)pyridin-3-amine (CAS 1052714-68-7)
- (R)-2-((((9H-Fluoren-9-yl)methoxy)carbonyl)amino)-4-(4-iodophenyl)butanoic acid (CAS 2349626-82-8)
- Semaglutide Impurity 180 (CAS CATO-C4X-2226180)
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