Ribociclib

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2-chloro-N-cyclopentylpyrimidin-4-amine

  • CAT NUMBER DCTI-C-363
  • CAS NUMBER 868591-58-6
  • MOLECULAR FORMULA C9H12ClN3
  • MOLECULAR WEIGHT 197.67

5-bromo-4-chloro-N-cyclopentylpyrimidin-2-amine

  • CAT NUMBER DCTI-C-343
  • CAS NUMBER 1823404-28-9
  • MOLECULAR FORMULA C9H11BrClN3
  • MOLECULAR WEIGHT 276.56

5-Bromo-N2,N4-dicyclopentylpyrimidine-2,4-diamine

  • CAT NUMBER DCTI-C-300
  • CAS NUMBER NA
  • MOLECULAR FORMULA C14H21BrN4
  • MOLECULAR WEIGHT 325.25

Amine Impurity

  • CAT NUMBER DCTI-C-2161
  • CAS NUMBER 1331847-17-6
  • MOLECULAR FORMULA C14H19N5O
  • MOLECULAR WEIGHT 273.34

Amino Trityl Impurity

  • CAT NUMBER DCTI-C-2160
  • CAS NUMBER 2524428-13-3
  • MOLECULAR FORMULA C28H28N4
  • MOLECULAR WEIGHT 420.56

Chloroamide Impurity

  • CAT NUMBER DCTI-C-2162
  • CAS NUMBER 1211443-61-6
  • MOLECULAR FORMULA C14H17ClN4O
  • MOLECULAR WEIGHT 292.77

N-Trityl Ribociclib

  • CAT NUMBER DCTI-C-2163
  • CAS NUMBER 2524428-16-6
  • MOLECULAR FORMULA C42H44N8O
  • MOLECULAR WEIGHT 676.87

RCB – Cyclopentyl amine alkyne impurity

  • CAT NUMBER DCTI-C-306
  • CAS NUMBER NA
  • MOLECULAR FORMULA C12H14ClN3O
  • MOLECULAR WEIGHT 251.71

RCB-Alkyne Acid Impurity

  • CAT NUMBER DCTI-C-305
  • CAS NUMBER NA
  • MOLECULAR FORMULA C15H15N3O3
  • MOLECULAR WEIGHT 285.3
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General Information

Ribociclib Impurities and Ribociclib

Daicel Pharma synthesizes Ribociclib impurity standards such as Ribociclib Piperizine Impurity, N-Trityl Ribociclib, 5-bromo-4-chloro-N-cyclopentylpyrimidin-2-amine, Amino Trityl Impurity, Triphenyl Iso-Propyl Ether Impurity, Amine Impurity, and Chloroamide Impurity, etc. The presence of these impurities is essential for the safety, stability, quality, and analysis of Ribociclib. Furthermore, Daicel Pharma offers custom synthesis for Ribociclib impurities, as per the client’s need, with an international delivery facility.

Ribociclib [CAS: 1211441-98-3] is a medication used to treat advanced breast cancer.

Ribociclib: Use and Commercial Availability 

Ribociclib is a selective cyclin-dependent kinase inhibitor, a type of cancer medication that blocks two proteins called cyclin-dependent kinase 4 and 6 (CDK4/6). It treats women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2) negative advanced or metastatic breast cancer. This drug is available in the market under the tradename of Kisqali.

Ribociclib Structure and Mechanism of Action Ribociclib Structure and Mechanism of Action

The chemical name of Ribociclib is 7-Cyclopentyl-N, N-dimethyl-2-[[5-(1-piperazinyl)-2-pyridinyl]amino]-7H-pyrrolo[2,3-d]pyrimidine-6-carboxamide. Its chemical formula is C23H30N8O, and its molecular weight is approximately 434.5 g/mol.

Ribociclib blocks CDK4/6 with great accuracy so that cancer cells do not proliferate uncontrolled.

Ribociclib Impurities and Synthesis

Ribociclib impurities are chemical compounds that occur unintentionally during the production1 or storage of Ribociclib, a drug used to treat certain kinds of breast cancer. These impurities might come from raw materials, reagents, intermediates, or degradation products. Ribociclib synthesis entails several synthetic stages and purification techniques to achieve the purest form of the drug.

Daicel Pharma offers a Certificate of Analysis (CoA) for Ribociclib impurity standards such as Ribociclib Piperizine Impurity, N-Trityl Ribociclib, 5-bromo-4-chloro-N-cyclopentylpyrimidin-2-amine, Amino Trityl Impurity, Triphenyl Iso-Propyl Ether Impurity, Amine Impurity, Chloroamide Impurity, etc. Daicel Pharma’s cGMP-certified analytical laboratory provides comprehensive CoA with detailed characterization data such as 1H NMR, 13C NMR, IR, MASS, and HPLC purity2. More characterization details, such as those for 13C-DEPT, can be provided on request. Daicel Pharma specializes in synthesizing impurities and degradation products. At Daicel Pharma, we can provide Ribociclib-D8, a pure deuterium-labeled Ribociclib standard, crucial for bioanalytical research and Bioavailability/Bioequivalence (BA/BE) studies.

References
FAQ's

Frequently Asked Questions

Ribociclib impurities are detected and analyzed using analytical techniques such as high-performance liquid chromatography (HPLC) and mass spectrometry (MS).

There are specific Ribociclib impurities of particular concern due to their potential impact on patient safety.

Measures such as careful selection of starting materials, optimization of reaction conditions, and implementation of purification techniques help control and minimize the presence of Ribociclib impurities during its synthetic process.

Ribociclib impurities should be stored at a controlled room temperature between 2-8°C or as indicated on the Certificate of Analysis (CoA).

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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