1A00390

NEBRAMINA

Pharmaceutical Analytical Impurity (PAI)

• Synonim(y): Nebramine, ((1S,2R,3R,4S,6R)-4,6-diamino-3-(((2R,3R,5S,6R)-3-amino-6-(aminomethyl)-5-hydroxytetrahydro-2H-pyran-2-yl)oxy)cyclohexane-1,2-diol)
• Wzór empiryczny (zapis Hilla): C₁₂H₂₆N₄O₅
• Numer CAS: 34051-04-2
• Masa cząsteczkowa: 306.36
• NACRES: NA.24
• UNSPSC Code: 41116107
• eCl@ss: 32120505

Właściwości

• grade: pharmaceutical analytical impurity (PAI)
• agency: USP
• API family: tobramycin
• manufacturer/tradename: USP
• application(s): pharmaceutical; pharmaceutical; pharmaceutical small molecule
• format: neat
• storage temp.: -10 to -25°C

Opis

General description

Find answers to frequently asked questions on USP products in USP FAQs.

NEBRAMINE is a USP Pharmaceutical Analytical Impurity (PAI).
USP PAI are a product line of impurities suitable for research and analytical purposes, which help to ensure the quality and safety of medicines.
Associated Drug Substance: Tobramycin
Therapeutic Area: Antibiotics

Application

NEBRAMINE (USP PAI) is intended for use in analytical testing to detect, identify, and measure pharmaceutical impurities.

Features and Benefits

USP PAI advance your early analytical R&D and process development. PAI can be used in the following applications:
1. Conduct analytical tests during early formulation feasibility studies.
2. Determine degradation impurities produced during stress studies.
3. Develop, validate, and transfer analytical methods.
4. Perform spiking studies during process R&D to demonstrate depletion upon recrystallization.
5. Record retention times and/or spectra
6. Determine relative response factors.
7. Identify unknown impurities that formed during ICH stability conditions.
8. Identify impurities that are present in the Reference Listed Drug
9. Test for and profile impurities not listed in drug substance and drug product monographs.

Analysis Note

Produkty te są przeznaczone wyłącznie do testów i oznaczeń. Nie są one przeznaczone do podawania ludziom lub zwierzętom i nie mogą być stosowane do diagnozowania, leczenia lub wyleczenia jakichkolwiek chorób.

Other Notes

Kartę SDS wydaną przez USP można znaleźć tutaj.

Sales restrictions may apply.

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Informacja o środkach bezpieczeństwa

• Piktogramy: GHS07
• Słowo ostrzegawcze: Warning
• Kody zagrożeń: H315
• Ostrzeżenia: P264 - P280 - P302 + P352 - P332 + P313 - P362 + P364
• Hazard Classifications: Skin Irrit. 2
• Klasa składowania: 11 - Combustible Solids
• Co się dzieje?: WGK 3
• Temperatura zapłonu (°F): Not applicable
• Temperatura zapłonu (°C): Not applicable