Description

Raltegravir CAS NO 1100750-83-1 is a potent and selective integrase strand transfer inhibitor (INSTI) used as an active pharmaceutical ingredient (API). This compound is critical for the formulation of antiretroviral medications that treat HIV-1 infection by blocking the integration of viral DNA into the host genome. It is essential for pharmaceutical manufacturers, research institutions, and contract development and manufacturing organizations (CDMOs) engaged in the production of innovative and generic antiviral therapies.

Application

• Pharmaceutical API: Primary use as the active ingredient in antiretroviral drug formulations for the treatment of HIV-1 infection.

• Finished Dosage Forms: Direct compression into tablets (e.g., Isentress®) or formulation into oral suspensions.

• Clinical Research: Serves as a reference standard and key material in preclinical and clinical studies for HIV therapy development.

• Generic Drug Manufacturing: Critical for companies developing bioequivalent versions of branded integrase inhibitor medications.

• Combination Therapies: Used in the development of fixed-dose combination (FDC) products with other antiretroviral agents.

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  | Product Name | Raltegravir |
  | CAS No. | 1100750-83-1 |
  | Molecular Formula | C20H21FN6O5 |
  | Molecular Weight | 444.42 g/mol |
  | Synonyms | MK-0518; Isentress; N-[(4-Fluorophenyl)methyl]-1,6-dihydro-5-hydroxy-1-methyl-2-[1-methyl-1-[[(5-methyl-1,3,4-oxadiazol-2-yl)carbonyl]amino]ethyl]-6-oxo-4-pyrimidinecarboxamide; Raltegravir Potassium; Raltegravirum; (4-Fluorobenzyl)-N-(1-methyl-1-{[(5-methyl-1,3,4-oxadiazol-2-yl)carbonyl]amino}ethyl)-5-hydroxy-1-methyl-6-oxo-1,6-dihydropyrimidine-4-carboxamide |
  | EINECS | Contact for details |

  Quality Control

  Our Raltegravir is manufactured under strict quality management systems. Each batch is tested to ensure it meets stringent specifications for identity, purity, and potency, aligning with ICH guidelines and current Good Manufacturing Practices (cGMP). A comprehensive Certificate of Analysis (COA) detailing results for assay, related substances, residual solvents, and microbiological attributes is provided with every shipment.

  Storage

  Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic nature, the container must be kept tightly sealed in a low-humidity environment to prevent moisture absorption and degradation.

  Specification

  Item	Specification
  Appearance	White to off-white powder
  Identification (IR)	Conforms to reference standard
  Identification (HPLC)	Retention time matches reference
  Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
  Water Content (KF)	≤ 1.0%
  Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
  Residual Solvents (GC)	Complies with ICH Q3C
  Heavy Metals	≤ 20 ppm
  Sulfated Ash	≤ 0.2%
  Microbiological Enumeration	Complies with Ph. Eur. 2.6.12/ USP <61>

  Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.**