Description

Raltegravir Potassium is the active pharmaceutical ingredient (API) of the integrase strand transfer inhibitor class, used in the formulation of antiretroviral medications. Its primary value lies in its critical role in the treatment of HIV-1 infection, offering a targeted mechanism of action that inhibits viral replication. This high-purity compound is essential for pharmaceutical manufacturers engaged in the production of solid dosage forms, such as tablets and capsules, for global healthcare markets.

Application

• Pharmaceutical API: Primary use as the active ingredient in the manufacture of antiretroviral drugs for HIV-1 treatment.
• Tablet Formulation: Direct compression or granulation processes for producing oral solid dosage forms like Isentress®.
• Clinical Research: Serves as a reference standard and raw material in preclinical and clinical studies for new HIV therapies.
• Generic Drug Manufacturing: Key starting material for the production of bioequivalent generic versions post-patent expiry.
• Combinatorial Therapy: Used in fixed-dose combination (FDC) products with other antiretroviral agents.

Basic Information

Product Name	Raltegravir Potassium
CAS No.	871038-72-1
Molecular Formula	C20H20FN6O5•K
Molecular Weight	482.51 g/mol
Synonyms	Raltegravir K; Raltegravir Potassium Salt; MK-0518 Potassium Salt; 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 Potassium Salt; Isentress API; (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 Potassium Salt
EINECS	Contact for details

Quality Control

Our Raltegravir Potassium is manufactured under strict quality management systems, targeting compliance with ICH Q7 guidelines and current Good Manufacturing Practices (cGMP). Each batch is supported by a comprehensive Certificate of Analysis (COA) detailing purity, identity, and impurity profiles. We ensure rigorous testing against established pharmacopeial standards to guarantee batch-to-batch consistency and reliability for critical pharmaceutical applications.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed in a dry environment to prevent degradation. For long-term storage, consider desiccants or inert atmosphere conditions.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water Content (KF)	≤ 5.0%
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Heavy Metals	≤ 20 ppm
Microbial 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.