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Lopinavir EP Impurity-E

  • CAT Number DCTI-C-535
  • CAS Number 192725-49-8
  • Molecular Formula C28H34N2O3
  • Molecular Weight 446.59

Lopinavir EP Impurity-F

  • CAT Number DCTI-C-536
  • CAS Number NA
  • Molecular Formula C29H34N2O4
  • Molecular Weight 474.6

Lopinavir EP Impurity-G

  • CAT Number DCTI-C-460
  • CAS Number NA
  • Molecular Formula C30H36N2O4
  • Molecular Weight 488.63
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Lopinavir Metabolite M1 Impurity

  • CAT Number DCTI-A-192
  • CAS Number 192725-39-6
  • Molecular Formula C37H46N4O6
  • Molecular Weight 642.8

Lopinavir Metabolite M3-M4 Impurity

  • CAT Number DCTI-A-196
  • CAS Number 357275-54-8
  • Molecular Formula C37H48N4O6
  • Molecular Weight 644.81

General Information

Lopinavir Impurities and Lopinavir

For evaluating the purity and safety of Lopinavir, an essential active pharmaceutical ingredient, Daicel Pharma offers a customized synthesis of Lopinavir impurity standards. These impurity standards include crucial compounds such as Lopinavir EP Impurity-E, Lopinavir EP Impurity-F, Lopinavir EP Impurity-G, Lopinavir Metabolite M1 Impurity, and Lopinavir Metabolite M3-M4 Impurity. Additionally, Daicel Pharma provides worldwide delivery options for Lopinavir impurity standards.

Lopinavir [CAS: 192725-17-0] is an antiretroviral protease inhibitor in combination with ritonavir for treating and preventing HIV infection and AIDS. It is a peptidomimetic HIV protease inhibitor that remains effective against HIV protease even in the presence of the Val 82 mutation.

Lopinavir: Use and Commercial Availability

Kaletra is the brand name for the combination product Lopinavir/Ritonavir, which combines with antiretrovirals and treats HIV-1 infection in adults and pediatric patients ≥14 days old. This product consists of an HIV protease inhibitor, Lopinavir, and the inhibitor of cytochrome P-450 CYP3A, Ritonavir.

Lopinavir Structure and Mechanism of ActionLopinavir Structure and Mechanism of Action 

The chemical name of Lopinavir is (αS)-N-[(1S,3S,4S)-4-[[2-(2,6-Dimethylphenoxy)acetyl]amino]-3-hydroxy-5-phenyl-1-(phenylmethyl)pentyl]tetrahydro-α-(1-methylethyl)-2-oxo-1(2H)-pyrimidineacetamide. Its chemical formula is C37H48N4O5, and its molecular weight is approximately 628.8 g/mol.

Lopinavir prevents the cleavage of the Gag-Pol polyprotein. It inhibits the preparation of immature, non-infectious viral particles.

Lopinavir Impurities and Synthesis

Impurities in Lopinavir are unintended substances that can be present in the drug product with the active pharmaceutical ingredient (API). They may originate from manufacturing1, starting materials, or interactions with environmental factors. Common Lopinavir impurities include related compounds, degradation products, residual solvents, and process-related impurities. It is crucial to monitor and control the levels of these impurities during manufacturing to ensure the safety, efficacy, and quality of the Lopinavir drug product. Regulatory authorities have established guidelines and limits for impurity levels to maintain purity and minimize potential risks associated with the drug. Stringent quality control measures minimize impurity levels and ensure product integrity.

Daicel Pharma strictly adheres to cGMP standards and operates an analytical facility for preparing Lopinavir impurity standards, which include Lopinavir EP Impurity-E, Lopinavir EP Impurity-F, Lopinavir EP Impurity-G, Lopinavir Metabolite M1 Impurity, and Lopinavir Metabolite M3-M4 Impurity. Our Lopinavir 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 Lopinavir impurity standards and degradation products. Each delivery has a comprehensive characterization report.


Frequently Asked Questions

Some impurities in Lopinavir, particularly related compounds, may interact with other drugs, leading to drug-drug interactions. Proper monitoring and control of impurity levels help minimize the risk of such interactions and ensure the drug's safety and effectiveness.

Impurities in Lopinavir can potentially affect its bioequivalence to other formulations. Regulatory agencies require that generic formulations demonstrate comparable impurity profiles and bioequivalence to the reference product to ensure therapeutic equivalence and patient safety.

Methanol and Acetonitrile are solvents used when analyzing many impurities in Lopinavir.

Lopinavir 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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