Description

Sinapultide is a synthetic lung surfactant protein C (SP-C) analogue, a critical active pharmaceutical ingredient (API) designed to mimic the surface tension-lowering properties of natural pulmonary surfactant. This compound is essential for the formulation of advanced respiratory distress syndrome (RDS) therapeutics, particularly for neonatal and adult applications. It is primarily utilized by pharmaceutical manufacturers and research institutions developing life-saving pulmonary medications and conducting cutting-edge respiratory research.

Application

• Active Pharmaceutical Ingredient (API) in synthetic lung surfactant preparations for the treatment of Respiratory Distress Syndrome (RDS) in neonates and adults.
• Critical component in research and development of next-generation pulmonary therapeutics targeting surfactant deficiency.
• Biochemical research tool for studying the structure, function, and mechanism of action of surfactant protein C (SP-C) in lung physiology.
• Reference standard in analytical laboratories for quality control and method development of surfactant-based drug products.
• Key material in preclinical and clinical studies evaluating the efficacy and safety of exogenous surfactant replacements.

Basic Information

Product Name	Sinapultide
CAS No.	138531-07-4
Molecular Formula	C161H267N43O49
Molecular Weight	~3498.1 g/mol
Synonyms	KL4 peptide; Sinapultide acetate; Lucinactant (drug substance); Surfaxin API; Synthetic SP-C analogue; KL4 surfactant peptide; (Leu-Lys-Leu-Leu)4Lys; rSP-C (Leu, Lys)
EINECS	Contact for details

Quality Control

Our Sinapultide is manufactured under strict quality management systems. Each batch is subjected to comprehensive analytical testing including HPLC for purity and peptide content, mass spectrometry for identity confirmation, and rigorous tests for residual solvents and related substances. A Certificate of Analysis (COA) documenting compliance with in-house specifications is provided with every shipment to ensure traceability and quality assurance for pharmaceutical development.

Storage

Preserve in a tightly closed container, protected from light. Store at -20°C or below. This product is hygroscopic (moisture-sensitive). Allow the vial to reach room temperature in a desiccator before opening to prevent condensation and moisture uptake. For long-term storage, keep containers sealed under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white lyophilized powder
Identification (HPLC/MS)	Conforms to reference standard
Assay (HPLC)	≥ 95.0% (on anhydrous basis)
Purity (Related Substances, HPLC)	Total impurities ≤ 5.0%
Peptide Content (Amino Acid Analysis)	≥ 80.0%
Water Content (KF)	≤ 10.0%
Acetate Content (IC)	5.0% - 15.0%
Bacterial Endotoxins	< 10.0 EU/mg

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