Raltegravir Potassium is the potassium salt of raltegravir and an established HIV-1 integrase strand transfer inhibitor (INSTI) used as part of combination antiretroviral therapy. It inhibits HIV integrase-mediated strand transfer, preventing integration of viral DNA into the host-cell genome.
Raltegravir Potassium is a pharmaceutical active ingredient with an established USP-NF monograph. The USP specifies an assay of 98.0%–102.0%, calculated on an anhydrous and solvent-free basis.
As a Raltegravir Potassium API Manufacturer in India, the product can be manufactured and controlled using appropriate pharmaceutical analytical procedures covering identity, assay, related substances, water content and other applicable quality attributes.
Product Name: Raltegravir Potassium
API Category: Antiviral API
Therapeutic Class: Antiretroviral
Drug Class: HIV-1 Integrase Strand Transfer Inhibitor
CAS Number: 871038-72-1
Molecular Formula: C20H20FKN6O5
Molecular Weight: 482.51 g/mol
UNII: 43Y000U234
PubChem CID: 23668479
Synonyms: Raltegravir Potassium Salt, Raltegravir Monopotassium Salt, MK-0518 Potassium
Free Raltegravir CAS: 518048-05-0
Raltegravir Potassium is the monopotassium salt of raltegravir. The potassium salt has a molecular weight of 482.51 g/mol and molecular formula C20H20FKN6O5.
The compound has an exact mass of 482.11162741 Da, hydrogen-bond donor count of 2, hydrogen-bond acceptor count of 9, 6 rotatable bonds, and a topological polar surface area of 153 Ų.
Raltegravir Potassium is described as a white to off-white powder. It is soluble in water, slightly soluble in methanol, very slightly soluble in ethanol and acetonitrile, and insoluble in isopropanol.
Raltegravir Potassium is used as an active pharmaceutical ingredient in antiretroviral products for the management of HIV-1 infection.
It is used in combination with other antiretroviral medicines and is relevant to the development and manufacture of:
Raltegravir is an HIV-1 integrase strand transfer inhibitor. HIV integrase plays an essential role in incorporating viral DNA into the host-cell genome.
Raltegravir inhibits the strand-transfer activity of HIV-1 integrase. This prevents integration of viral DNA into host DNA and interferes with productive HIV replication.
Raltegravir Potassium has an established USP-NF monograph with an assay requirement of NLT 98.0% and NMT 102.0%, calculated on an anhydrous and solvent-free basis.
Identity testing includes spectroscopic identification, chromatographic retention-time comparison and potassium identification.
Analytical testing can include:
Raltegravir Potassium API manufacturing involves controlled chemical synthesis followed by purification, isolation and drying to obtain pharmaceutical-quality potassium salt.
Manufacturing controls may include:
| Property | Value |
|---|---|
| Product | Raltegravir Potassium |
| CAS Number | 871038-72-1 |
| Molecular Formula | C20H20FKN6O5 |
| Molecular Weight | 482.51 g/mol |
| Appearance | White to off-white powder |
| Solubility in Water | Soluble |
| Methanol | Slightly soluble |
| Ethanol | Very slightly soluble |
| Acetonitrile | Very slightly soluble |
| Isopropanol | Insoluble |
| Exact Mass | 482.11162741 Da |
| H-Bond Donors | 2 |
| H-Bond Acceptors | 9 |
| Rotatable Bonds | 6 |
| TPSA | 153 Ų |
| Stereocenters | 0 |
Raltegravir Potassium API should be packaged in suitable pharmaceutical-grade containers that protect the material from contamination and inappropriate environmental exposure.
For finished raltegravir products, storage is generally maintained at 20–25°C, with permitted excursions to 15–30°C under controlled-room-temperature conditions.
For bulk API, the final storage conditions should follow validated stability data and the approved API specification.
Typical pharmaceutical API documentation may include:
Raltegravir Potassium requires controlled manufacturing and analytical testing because it is an established antiretroviral API with defined pharmacopoeial quality requirements.
A qualified Raltegravir Potassium API Manufacturer in India should maintain control over raw materials, synthesis, purification, drying, analytical testing and batch documentation.
The established USP monograph provides important benchmarks for identity, assay, related substances and water content, while additional product-specific requirements can be incorporated according to the intended pharmaceutical application.
| Parameter | Specification |
|---|---|
| Appearance | white to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 98.0% – 102.0% |
| Loss on Drying | NMT 0.5% |
| Residue on Ignition | NMT 0.1% |
| Heavy Metals | NMT 10 ppm |
| Individual Impurity | NMT 0.10% |
| Total Impurities | NMT 0.50% |