Palbociclib

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6-Desacetyl 6-Bromopalbociclib

  • CAT Number DCTI-C-1538
  • CAS Number 851067-56-6
  • Molecular Formula C22H26BrN7O
  • Molecular Weight 484.4

6-Desacetyl Palbociclib

  • CAT NUMBER DCTI-C-1541
  • CAS NUMBER 571190-22-2
  • MOLECULAR FORMULA C22H27N7O
  • MOLECULAR WEIGHT 405.51

6-desacetyl-N-Boc-Palbociclib

  • CAT NUMBER DCTI-C-1402
  • CAS NUMBER 571189-65-6
  • MOLECULAR FORMULA C27H35N7O3
  • MOLECULAR WEIGHT 505.62

Desoxo-Palbociclib

  • CAT Number DCTI-C-1539
  • CAS Number 2204863-06-7
  • Molecular Formula C24H29N7O
  • Molecular Weight 431.54

Palbociclib 2-Hydroxy acetyl Impurity

  • CAT NUMBER DCTI-C-2117
  • CAS NUMBER 2172256-78-7
  • MOLECULAR FORMULA C15H17N3O3
  • MOLECULAR WEIGHT 287.32

Palbociclib 2-Oxoethane-1-sulfonic acid

  • CAT Number DCTI-C-700
  • CAS Number NA
  • Molecular Formula C24H29N7O5S
  • Molecular Weight 527.6

Palbociclib Chloro Bromo Impurity

  • CAT NUMBER DCTI-C-2115
  • CAS NUMBER 1016636-76-2
  • MOLECULAR FORMULA C13H13BrClN3O
  • MOLECULAR WEIGHT 342.62

Palbociclib Glycosamine

  • CAT Number DCTI-C-701
  • CAS Number NA
  • Molecular Formula C36H49N7O12
  • Molecular Weight 771.83

Palbociclib Impurity 5

  • CAT NUMBER DCTI-C-2116
  • CAS NUMBER NA
  • MOLECULAR FORMULA C35H48BrN7O7
  • MOLECULAR WEIGHT 758.72
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General Information

Palbociclib Impurities and Palbociclib

Daicel Pharma synthesizes more than thirty high-quality Palbociclib impurities, such as 6-Desacetyl 6-BromoPalbociclib, 6-Desacetyl Palbociclib, Desoxo-Palbociclib, Palbociclib Glycosamine, Palbociclib Chloro Bromo Impurity, Palbociclib N-Boc Impurity, Palbociclib N-Hydroxy Piperazine, Palbociclib Nitroso Impurity, PBC Amine Isomer Impurity, etc., crucial in determining the quality, stability, and biological safety of the active pharmaceutical ingredient Palbociclib. Moreover, Daicel Pharma offers custom synthesis of Palbociclib impurities and delivers them globally.

Palbociclib [CAS: 571190-30-2] is a pyrido-pyrimidine derivative, an inhibitor of cyclin-dependent kinases. It is utilized with aromatase inhibitors for treating metastatic breast cancer in postmenopausal women.

Palbociclib: Use and Commercial Availability 

Palbociclib is marketed under the trade name Ibrance for treating advanced hormone-receptor-positive breast cancer in women. It is a part of anti-hormonal therapy, either in combination with an aromatase inhibitor or a selective estrogen receptor modulator (SERM). By inhibiting cell division in cancer cells, Palbociclib slows down tumor growth. The drug is available in capsule form in three different doses. Palbociclib Structure and Mechanism of Action

Palbociclib Structure and Mechanism of Action

The chemical name of Palbociclib is 6-Acetyl-8-cyclopentyl-5-methyl-2-[[5-(piperazin-1-yl)pyridin-2-yl]amino]-8H-pyrido[2,3-d]pyrimidin-7-one. The chemical formula for Palbociclib is C24H29N7O2, and its molecular weight is approximately 447.5 g/mol.

Palbociclib inhibits cyclin-dependant kinase (CDK) 4 and 6. This inhibition of CDK4/6 and cyclin D1 kinase activity prevents DNA synthesis and thus inhibits cell division.

Palbociclib Impurities and Synthesis

Palbociclib impurities are classified as isomers, degradants, and solvents. Isomers are due to the preparation of stereoisomers in the Palbociclib synthesis process, while degradants result from the instability of Palbociclib caused by hydrolysis, oxidation, or photolysis. Solvents like acetic acid, ethyl acetate, and dimethyl sulfoxide (DMSO) may produce impurities during the synthetic process. For instance, N-desmethyl Palbociclib is an isomeric impurity, while 4-hydroxypiperidin-1-yl Palbociclib is a degradant impurity. These impurities can affect the safety, quality, and efficacy of the final product. Therefore, it is crucial to control impurities during the Palbociclib synthetic1 and purification processes and analyze the final product to ensure it is safe and effective.

Daicel offers a Certificate of Analysis (CoA) from a cGMP-compliant analytical facility for more than thirty Palbociclib impurity standards2 including 6-Desacetyl 6-BromoPalbociclib, 6-Desacetyl Palbociclib, Desoxo-Palbociclib, Palbociclib Glycosamine, Palbociclib Chloro Bromo Impurity, Palbociclib N-Boc Impurity, Palbociclib N-Hydroxy Piperazine, Palbociclib Nitroso Impurity, PBC Amine Isomer Impurity, and more. The CoA includes complete characterization data, such as 1H NMR, 13C NMR, IR, MASS, and HPLC purity. We also provide 13C-DEPT and CHN on request. We also give a complete characterization report on delivery.

Daicel has the technology and expertise to prepare any unknown Palbociclib impurity or degradation product. The company also provides labeled compounds to quantify the efficacy of generic Palbociclib. Daicel offers highly pure Palbociclib-d8, a deuterium-labeled standard of Palbociclib for bioanalytical research and BA/BE studies with the percentage of isotope data in CoA.

References
FAQ's

Frequently Asked Questions

The potential sources of impurities in Palbociclib include starting materials, reagents, solvents, degradation products, and processing aids used during manufacturing.

Analytical methods such as HPLC, and LC-MS help identify and quantify Palbociclib impurities.

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.

The recommended storage temperature for Palbociclib Impurities is 2-8°C in general. However, it depends upon the stability of the compound.

Note: Products protected by valid patents by a manufacturer are not offered for sale in countries having patent protection. The sale of such products constitutes a patent infringement, and its liability is at the buyer's risk.

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