Description

Ibuprofen Lysinate is a pharmaceutical-grade salt formed from ibuprofen and L-lysine, designed to enhance solubility and bioavailability. This advanced formulation offers a critical advantage for rapid-onset analgesic and anti-inflammatory therapies. It is an essential active pharmaceutical ingredient (API) for manufacturers developing high-performance oral solid dosage forms, particularly effervescent tablets, granules, and fast-dissolving formulations. The product meets the stringent demands of the global pharmaceutical industry for reliable and effective pain management solutions.

Application

• Pharmaceutical API: Primary use as the active ingredient in analgesic and anti-inflammatory medications.
• Effervescent Tablets & Granules: Ideal for formulations requiring rapid dissolution and improved patient compliance, especially for dysphagic patients.
• Fast-Dissolving Oral Dosage Forms: Used in orally disintegrating tablets (ODTs) and films for quick systemic absorption.
• Pediatric & Geriatric Formulations: Suitable for age-appropriate dosage forms due to its improved solubility and palatability.
• Over-the-Counter (OTC) Medications: Key component in OTC products for headaches, dental pain, muscle aches, and fever reduction.
• Veterinary Pharmaceuticals: Applied in anti-inflammatory treatments for companion animals and livestock.

Basic Information

Product Name	Ibuprofen Lysinate
CAS No.	57469-76-8
Molecular Formula	C19H32N2O4
Molecular Weight	352.47 g/mol
Synonyms	Ibuprofen L-Lysine Salt; Ibuprofen Lysine; Lysine Ibuprofenate; (S)-2,6-Diaminohexanoic acid compound with (RS)-2-(4-isobutylphenyl)propanoic acid (1:1); DL-Lysine ibuprofen salt; Ibuprofen lysine salt; Ibuprofen mono-L-lysinate; (+)-Lysine ibuprofen
EINECS	Contact for details

Quality Control

Our Ibuprofen Lysinate is manufactured under strict quality management systems, targeting compliance with major pharmacopoeial standards such as USP and EP. Each batch undergoes comprehensive analytical testing including identification, assay, impurity profiling, and residual solvent analysis. A Certificate of Analysis (COA) documenting purity, related substances, and other critical parameters is provided with every shipment to ensure traceability and regulatory compliance for our global B2B clients.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept in a dry environment to prevent degradation and caking.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms
Identification (HPLC)	Conforms
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water (KF)	≤ 1.0%
Related Substances (HPLC)	Individual impurity ≤ 0.5%; Total impurities ≤ 1.5%
Residual Solvents (GC)	Complies with ICH Q3C
Heavy Metals	≤ 20 ppm
Specific Rotation	+18.0° to +22.0° (c=1 in H2O)
pH (5% solution)	6.0 - 8.0

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