Description

Rusalatide Acetate is a synthetic peptide derivative developed for targeted biological activity in preclinical and pharmaceutical research applications. It serves as a high-purity reference standard and active pharmaceutical ingredient (API) intermediate, valued for its structural specificity and batch-to-batch consistency. Researchers and contract development and manufacturing organizations (CDMOs) across oncology, metabolic disease, and immunomodulation programs rely on this compound for assay development, stability studies, and formulation optimization. Rusalatide Acetate CAS NO 875455-82-6 is supplied under strict quality governance to support regulatory submissions and GMP-aligned processes.

Application

• Preclinical pharmacokinetic and pharmacodynamic (PK/PD) studies in rodent and non-rodent models
• Reference standard for LC-MS/MS and HPLC method validation in bioanalytical laboratories
• Lead compound in structure-activity relationship (SAR) screening for G-protein-coupled receptor (GPCR) modulation
• Active ingredient in investigational formulations for sustained-release peptide delivery systems
• Calibration material for quantitative mass spectrometry in clinical trial biomarker assays
• Stability-indicating impurity reference for forced degradation studies (acidic, oxidative, thermal)
• Tool compound in cell-based functional assays evaluating insulin sensitization pathways
• Starting material in multi-step synthesis of labeled analogues (e.g., 13C- or 15N-labeled derivatives)

Basic Information

Product Name	Rusalatide Acetate
CAS No.	875455-82-6
Molecular Formula	C65H102N18O20
Molecular Weight	1427.61 g/mol
Synonyms	Rusalatide acetate; Rusalatide acetate salt; N-Acetyl-Rusalatide; Ac-Rusalatide-OH; Rusalatide (acetate form); [Ac-Rusalatide]; Rusalatide, acetylated; Rusalatide, monoacetate
EINECS	Contact for details

Quality Control

Our products undergo rigorous quality testing to ensure compliance with industry standards. Certificates of Analysis (COA) are available upon request. All batches are tested per ICH Q5, Q6, and Q7 guidelines and conform to applicable sections of USP General Chapter <1086> Peptide Purity and USP <1119> Chromatography. Testing includes identity (IR, NMR, MS), assay (HPLC), related substances (HPLC), residual solvents (GC), water content (KF), and microbiological limits where appropriate.

Storage

Preserve in a tightly closed container, protected from light. Store at 2–8°C under inert atmosphere (nitrogen or argon) to prevent oxidation and moisture uptake. Keep desiccated with silica gel in the secondary packaging. Avoid repeated opening and exposure to ambient humidity.

Specification

Item	Specification
Appearance	White to off-white lyophilized powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	98.0–102.0% (as-is basis)
Related Substances	≤ 2.0% total impurities
Single Impurity	≤ 0.5%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Meets ICH Q3C limits
Heavy Metals	≤ 10 ppm
Microbial Limits	Total aerobic count ≤ 100 CFU/g; Absence of E. coli, S. aureus, P. aeruginosa, S. typhimurium

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