1A00770

Diamino Atorvastatin Calcium

Pharmaceutical Analytical Impurity (PAI)

• Synonim(y): (Calcium (3R,5R)-7-[[(3R,5R)-7-[2-(4-fluorophenyl)-5-(1-methylethyl)-3-phenyl-4-(phenylcarbamoyl)-1H-pyrrol-1-yl]-3,5-dihydroxyheptanoyl]amino]-3,5-dihydroxyheptanoate)
• Wzór empiryczny (zapis Hilla): C₄₀H₄₇FN₃O₈ . 1/2Ca
• Numer CAS: 1105067-87-5
• MDL number: MFCD00041426
• NACRES: NA.24
• UNSPSC Code: 41116107

Właściwości

• grade: pharmaceutical analytical impurity (PAI)
• agency: USP
• API family: atorvastatin calcium trihydrate
• manufacturer/tradename: USP
• application(s): pharmaceutical; pharmaceutical; pharmaceutical small molecule
• format: neat
• storage temp.: 2-8°C

Opis

General description

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

Diamino Atorvastatin Calcium 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: Atorvastatin Calcium
Therapeutic Area: Antihyperlipidemics

Application

Diamino Atorvastatin Calcium (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: GHS08,GHS09
• Słowo ostrzegawcze: Warning
• Kody zagrożeń: H373,H411
• Ostrzeżenia: P260 - P273 - P314 - P391 - P501
• Hazard Classifications: Aquatic Chronic 2 - STOT RE 2
• Klasa składowania: 11 - Combustible Solids
• Temperatura zapłonu (°F): Not applicable
• Temperatura zapłonu (°C): Not applicable