Hydantoin Impurity 16 CAS CATO-C4X-214616
| CAS No. | CATO-C4X-214616 |
| Molecular Formula | C7H12N2O3 |
| Molecular Weight | 172.18 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 Hydantoin Impurity 16.
CATO supplies Hydantoin Impurity 16 (CAS CATO-C4X-214616), a pharmacopoeial impurity reference standard (molecular formula C7H12N2O3, MW 172.18 g/mol) used for the identification and quantification of trace impurities in APIs.
Hydantoin Impurity 16 (C7H12N2O3) contains an amino-acid-derived structure, 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.
As a certified reference material (CRM), Hydantoin Impurity 16 meets the metrological traceability requirements of ISO/IEC 17025 laboratories. Batch-to-batch consistency is monitored via control charts to guarantee comparable assigned values across lots.
Physical & Chemical Properties
| Molecular Formula | C7H12N2O3 |
| Molecular Weight | 172.18 g/mol |
| Appearance | White to pale yellow crystalline powder. (faint amine-like odor) |
| Purity | >95% |
| Storage | Store at 2-8°C, protect from light, keep sealed and dry |
| Solubility (reference) | Soluble in methanol, ethanol, DMSO, water |
| Stability | May oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light; Hygroscopic; reseal immediately after opening |
| Degree of Unsaturation (DBE) | 3.0 |
| UV Absorption | UV-absorbing |
| Nitrogen Atoms | 2 |
Related Hydantoin Standards
- Hydantoin Impurity 14 (CAS 99669-71-3)
- Hydantoin Impurity 8 (CAS 7060-39-1)
- Hydantoin Impurity 9 (CAS CATO-C4X-21469)
- Hydantoin Impurity 10 (CAS CATO-C4X-214610)
- Hydantoin Impurity 4 (CAS 2361-15-1)
- Hydantoin Impurity 20 (CAS CATO-C4X-214620)
- Hydantoin 5-Acetic Acid (CAS 5427-26-9)
- Hydantoin Impurity 34 (CAS CATO-C4X-214634)
Recommended Standards
- Phytomenadione/Vitamin K1 Impurity 122 (CAS 571-63-1)
- Brivaracetam impurity 94 (CAS 2052297-76-2)
- Pilocarpine Impurity 6 (CAS CATO-C4X-24016)
- Bimatoprost Impurity 9 (CAS 32233-40-2)
- Lenvatinib Impurity 57 (CAS CATO-C4X-114057)
- Fosaprepitant impurity 57（S,R,R） (CAS CATO-C4X-116857)
- N-Nitroso Azithromycin Impurity 46 (CAS CATO-C4X-100346)
- Allopurinol EP Impurity D (USP RC D) (CAS 1260243-04-6)
- 1-tert-Butyl 2-ethyl (2S,4S)-4-hydroxypiperidine-1,2-dicarboxylate (CAS 180854-46-0)
- Pigment Red 57 (CAS 5281-04-9)
- 6,6'-([1,1'-Biphenyl]-4,4'-diylbis(oxy))bis(hexan-1-ol) (CAS 97087-90-6)
- Ethyl 2-(N,N-diethylamino)benzoate (CAS 94023-76-4)
- (11aS)-10,11,12,13-Tetrahydro-N,N-bis(1-methylethyl)diindeno[7,1-de:1',7'-fg][1,3,2]dioxaphosphocin-5-amine (CAS 477559-83-4)
- Semaglutide impurity 60 (CAS CATO-C4X-222660)
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