Description

Indinavir Sulfate is a potent and selective protease inhibitor used in antiretroviral therapy. This active pharmaceutical ingredient (API) is critical for the formulation of medications targeting the human immunodeficiency virus (HIV). It is essential for pharmaceutical manufacturers and research institutions developing treatments for HIV-1 infection. The compound is supplied as a high-purity material to ensure efficacy and safety in final drug products.

Application

• Pharmaceutical API: Primary active ingredient in the manufacture of antiretroviral capsules and tablets for HIV treatment.
• Research & Development: Used in biochemical and pharmacological studies to investigate protease inhibition mechanisms and novel drug combinations.
• Reference Standard: Serves as a high-purity analytical standard for quality control and assay development in pharmaceutical laboratories.
• Formulation Development: Employed in pre-formulation and formulation studies for solid dosage forms, including stability testing and excipient compatibility.
• Generic Drug Manufacturing: Key component for companies producing bioequivalent versions of HIV protease inhibitor medications.

Basic Information

Product Name	Indinavir Sulfate
CAS No.	157810-81-6
Molecular Formula	C36H47N5O4 • H2SO4
Molecular Weight	711.85 g/mol
Synonyms	Indinavir Sulphate; MK-639 Sulfate; L-735,524 Sulfate; (2S)-1-[(2S,4R)-4-Benzyl-2-hydroxy-4-[[(1S,2R)-2-hydroxy-2,3-dihydro-1H-inden-1-yl]carbamoyl]butyl]-N-tert-butyl-4-(pyridin-3-ylmethyl)piperazine-2-carboxamide Sulfate; Crixivan Sulfate (API form)
EINECS	Contact for details

Quality Control

Our Indinavir Sulfate is manufactured under strict quality management systems. Each batch is tested to meet stringent specifications for identity, purity, and potency, aligning with ICH guidelines. A comprehensive Certificate of Analysis (COA) is provided with every shipment, detailing results for assay, related substances, residual solvents, and microbiological limits. We support compliance with cGMP standards for pharmaceutical ingredient supply.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and must be kept in a dry environment to prevent degradation. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to 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 guidelines
Heavy Metals	≤ 20 ppm
Microbiological Enumeration	Meets Ph. Eur. / USP criteria

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