Tobramycin Impurity 12 xHAc CAS 51736-77-7(free base)
| CAS No. | 51736-77-7(free base) |
| Molecular Formula | C19H38N6O10 |
| Molecular Weight | N/A |
| 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 Tobramycin Impurity 12 xHAc.
CATO supplies Tobramycin Impurity 12 xHAc (CAS 51736-77-7(free base)), a pharmacopoeial impurity reference standard (molecular formula C19H38N6O10xC2H4O2, MW 570.60 g/mol) used for the identification and quantification of trace impurities in APIs.
Tobramycin Impurity 12 xHAc (C19H38N6O10xC2H4O2) contains a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage. It is notably hygroscopic, the carboxyl group imparts weak acidity; these physicochemical properties determine the optimal preparation and storage of its standard solutions. The presence of an aromatic ring or conjugated system gives the compound characteristic absorption bands in the UV-Vis region, making it well suited to UV or diode-array detection (DAD).
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 | C19H38N6O10 xC2H4O2 |
| Molecular Weight | 570.60 g/mol |
| Appearance | Off-white to pale yellow crystalline powder |
| Purity | >95% |
| Storage | Store in a cool place (≤25°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) | 4.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| Nitrogen Atoms | 6 |
Related Tobramycin Standards
- Tobramycin Impurity N2 (CAS 111170-72-0)
- Tobramycin Sulfate (CAS 126777-32-0)
- Tobramycin Impurity 2 (CAS 1488363-39-8)
- Tobramycin Impurity 13 HCl (CAS 19309-98-9 (free base))
- Tobramycin Impurity 15 (CAS 207670-58-4)
- Tobramycin (CAS 32986-56-4)
- Tobramycin 5/2sulfate (CAS 49842-07-1)
- Tobramycin Impurity N1 (CAS 51736-77-7)
Recommended Standards
- Enarodustat Impurity 27 (CAS CATO-C4X-322827)
- Nefopam Impurity 5 (CAS 13678-16-5)
- Cabazitaxel Impurity 2 (CAS 160084-81-1)
- n-[2-(morpholin-4-yl)ethyl]cyclopentanamine (CAS 637034-82-3)
- (2-Phenylcyclohexyl)methanol (CAS 92077-68-4)
- (Rp)-(1R,2S,5R)-2-Isopropyl-5-methylcyclohexyl (2-hydroxynaphthalen-1-yl)(phenyl)phosphinate (CAS 1464049-24-8)
- (2S,4S)-1-tert-Butyl 2-methyl 4-((4-nitrobenzoyl)-oxy)pyrrolidine-1,2-dicarboxylate (CAS 168264-25-3)
- tert-butyl (3S,4S)-3-(2-bromoacetyl)-4-methylpyrrolidine-1-carboxylate (CAS 2062661-46-3)
- 1-(3,5-Dimethylphenyl)-3-(m-tolyl)propan-1-one (CAS 898790-84-6)
- Semaglutide impurity 273 (CAS CATO-C4X-2226273)
Why CATO?
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