Lifitegrast

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(S)-benzyl 2-(5,7-dichloro-1,2,3,4-tetrahydroisoqu...

  • CAT NUMBER DCTI-C-2062
  • CAS NUMBER 1194864-18-0
  • MOLECULAR FORMULA C27H26Cl2N2O5S
  • MOLECULAR WEIGHT 561.47

5,7,8-TRICHLORO-1,2,3,4-TETRAHYDROISOQUINOLINE

  • CAT Number DCTI-C-413
  • CAS Number 73075-51-1
  • Molecular Formula C9H8Cl3N
  • Molecular Weight 236.52

Lifitegrast Impurity 1

  • CAT NUMBER DCTI-C-2059
  • CAS NUMBER 1194550-61-2
  • MOLECULAR FORMULA C32H34Cl2N2O7S
  • MOLECULAR WEIGHT 661.59

Lifitegrast Impurity 11

  • CAT NUMBER DCTI-C-2985
  • CAS NUMBER 77095-51-3
  • MOLECULAR FORMULA C9H6O3
  • MOLECULAR WEIGHT 162.14

Lifitegrast Impurity 3

  • CAT NUMBER DCTI-C-2061
  • CAS NUMBER 1194550-67-8
  • MOLECULAR FORMULA C36H30Cl2N2O7S
  • MOLECULAR WEIGHT 705.6

Lifitegrast Impurity 5

  • CAT NUMBER DCTI-C-2058
  • CAS NUMBER 2129597-34-6
  • MOLECULAR FORMULA C19H13Cl2NO4
  • MOLECULAR WEIGHT 390.22

Lifitegrast R-Isomer

  • CAT NUMBER DCTI-C-2060
  • CAS NUMBER 2271299-08-0
  • MOLECULAR FORMULA C29H24Cl2N2O7S
  • MOLECULAR WEIGHT 615.48

Lifitegrast tertiary butyl ester impurity

  • CAT NUMBER DCTI-C-2822
  • CAS NUMBER 2414639-05-5
  • MOLECULAR FORMULA C33H32Cl2N2O7S
  • MOLECULAR WEIGHT 671.59

General Information

Lifitegrast Impurities and Lifitegrast

For the purity and safety of Lifitegrast, an active pharmaceutical ingredient, Daicel Pharma offers a customized synthesis of Lifitegrast impurity standards. These impurity standards include crucial compounds such as (S)-benzyl 2-(5,7-dichloro-1,2,3,4-tetrahydroisoquinoline-6-carboxamido)-3 -(3-(methylsulfonyl)phenyl)propanoate, 5,7,8-trichloro-1,2,3,4-tetrahydroisoquinoline, Lifitegrast Impurity 1, Lifitegrast Impurity 3, Lifitegrast Impurity 5, Lifitegrast R-Isomer, and Lifitegrast tertiary butyl ester impurity. Additionally, Daicel Pharma provides worldwide delivery options for Lifitegrast impurity standards.

Lifitegrast [CAS: 1025967-78-5] is an anti-inflammatory drug and a lymphocyte function-associated antigen-1 antagonist for treating keratoconjunctivitis sicca, also known as dry eye syndrome.

Lifitegrast: Use and Commercial Availability

Lifitegrast, marketed as Xiidra, is a topical anti-inflammatory agent approved by the US FDA for treating dry eye syndrome. It acts as a small lymphocyte function-associated antigen-1 (LFA-1) antagonist, reducing inflammation and managing dry eye symptoms. Lifitegrast is administered as one drop of a 5% ophthalmic solution and used for artificial tears.

Lifitegrast Structure and Mechanism of ActionLifitegrast Structure and Mechanism of Action

The chemical name of Lifitegrast is N-[[2-(6-Benzofuranylcarbonyl)-5,7-dichloro-1,2,3,4-tetrahydro-6-isoquinolinyl]carbonyl]-3-(methylsulfonyl)-L-phenylalanine. Its chemical formula is C29H24Cl2N2O7S, and its molecular weight is approximately 615.5 g/mol.

Lifitegrast blocks the interaction of lymphocyte function-associated antigen-1 (LFA-1) with its cognate ligand intercellular adhesion molecule-1 (ICAM-1).

Lifitegrast Impurities and Synthesis 

Lifitegrast impurities are unintended substances that may be present in Lifitegrast formulations. They can occur during the drug’s synthesis1, storage, or transportation. It is essential to closely monitor and control impurity levels in Lifitegrast to ensure its safety, efficacy, and quality. Pharmaceutical manufacturers employ rigorous quality control measures to minimize impurity levels and maintain the purity of Lifitegrast. By adhering to strict guidelines and regulatory standards, companies strive to provide patients with reliable and effective Lifitegrast formulations for treating dry eye syndrome. Continuous monitoring and testing help ensure that impurities are kept at acceptable levels, maintaining their integrity throughout their shelf life.

Daicel Pharma strictly adheres to cGMP standards and operates an analytical facility for preparing Lifitegrast impurity standards, which include (S)-benzyl 2-(5,7-dichloro-1,2,3,4-tetrahydroisoquinoline-6-carboxamido)-3 -(3-(methylsulfonyl)phenyl)propanoate, 5,7,8-trichloro-1,2,3,4-tetrahydroisoquinoline, Lifitegrast Impurity 1, Lifitegrast Impurity 3, Lifitegrast Impurity 5, Lifitegrast R-Isomer, and Lifitegrast tertiary butyl ester impurity. Our Lifitegrast impurity standards have a detailed Certificate of Analysis (CoA) that provides a comprehensive characterization report. This report includes data obtained through techniques, 1H NMR, 13C NMR, IR, MASS, and HPLC purity analysis2. Upon request, we give additional data like 13C-DEPT. Moreover, we can synthesize unknown Lifitegrast impurity standards and degradation products. Each delivery has a comprehensive characterization report.

References
FAQ's

Frequently Asked Questions

While manufacturers strive to maintain consistent impurity profiles, minor variations in impurity levels may occur between batches of Lifitegrast.

Some impurities may interfere with the absorption, distribution, or metabolism of Lifitegrast, potentially affecting its bioavailability and therapeutic effects.

The degradation of excipients used in Lifitegrast can lead to the formation of impurities, which need to be carefully controlled and monitored.

Lifitegrast impurities should be stored at a controlled room temperature, usually between 2-8 °C.

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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