Palbociclib - NDSRI's
References
FAQ's
References
- Barvian, Mark Robert; Booth, Richard John; Quin, John, III; Repine, Joseph Thomas; Sheehan, Derek James; Toogood, Peter Laurence; Vanderwel, Scott Norman; Zhou, Hairong, “2-(Pyridin-2-ylamino)-pyrido[2,3-d]pyrimidin-7-ones”, Warner-Lambert Company Llc, United States, US6936612B2, August 30, 2005
- Ma, Xingling; Liu, Lei; Cao, Na; Zou, Qiaogen; Xiong, Kaihe; Ouyang, Pingkai, “Isolation and structural elucidation of Palbociclib's eight process-related impurities: two identified as new compounds”, Journal of AOAC International, Volume: 99, Issue: 3, Pages: 638-648, 2016
Frequently Asked Questions
What are the potential sources of impurities in Palbociclib?
The potential sources of impurities in Palbociclib include starting materials, reagents, solvents, degradation products, and processing aids used during manufacturing.
How are Palbociclib impurities identified and quantified?
Analytical methods such as HPLC, and LC-MS help identify and quantify Palbociclib impurities.
How are Palbociclib impurities monitored during stability studies?
Impurities in Palbociclib are monitored during stability studies using validated analytical methods to ensure that the drug product remains within the specified limits over the shelf life of the product.
What is the recommended storage temperature for Palbociclib Impurities?
The recommended storage temperature for Palbociclib Impurities is 2-8°C in general. However, it depends upon the stability of the compound.
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