Nintedanib

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Nintedanib N-Methyl impurity. TFA salt

  • CAT Number DCTI-C-1913
  • CAS Number NA
  • Molecular Formula (free base): C24H21N3O3 (Salt): C26H22F3N3O5
  • Molecular Weight (Free base): 399.45 (Salt): 513.47

Nintedanib N-oxide Impurity H

  • CAT Number DCTI-C-1914
  • CAS Number NA
  • Molecular Formula C31H33N5O6 (Free base) C33H39N5O9S (Salt)
  • Molecular Weight 571.63 (Free base) 681.76 (Salt)

Nintedanib N-oxide impurity I

  • CAT NUMBER DCTI-C-1946
  • CAS NUMBER NA
  • MOLECULAR FORMULA C31H33N5O5
  • MOLECULAR WEIGHT 555.64

Nintedanib-D3

  • CAT Number DCTI-A-116
  • CAS Number 1624587-84-3
  • Molecular Formula C31H30D3N5O4
  • Molecular Weight 542.65

Piperazine Dimer acetyl Impurity of Nintedanib CRS

  • CAT NUMBER DCTI-C-1944
  • CAS NUMBER 2410649-55-5
  • MOLECULAR FORMULA C60H56N8O10
  • MOLECULAR WEIGHT 1049.15

Piperazine Dimer impurity of Nintedanib CRS

  • CAT NUMBER DCTI-C-1945
  • CAS NUMBER 2410284-90-9
  • MOLECULAR FORMULA C56H52N8O8
  • MOLECULAR WEIGHT 965.08
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References
FAQ's

Frequently Asked Questions

The impurities do not necessarily imply harm, but their levels and nature need careful regulation. Health authorities set specific limits for impurity levels based on safety and efficacy considerations.

Impurities in Nintedanib can affect its effectiveness by altering the drug's pharmacokinetics, pharmacodynamics, or stability. Controlling them ensures the drug maintains its therapeutic potency and delivers the desired outcome.

Analytical techniques such as High-Performance Liquid Chromatography (HPLC), Mass Spectrometry (MS) help detect and quantify Nintedanib impurities. These methods enable accurate identification and measurement of impurity levels.

Nintedanib 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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