Description

IRL-1620 is a synthetic, peptide-based radiopharmaceutical precursor developed for targeted α-particle therapy and molecular imaging applications. It serves as a critical chelator-conjugated somatostatin analog with high affinity for somatostatin receptor subtype 2 (SSTR2), enabling precise delivery of therapeutic radionuclides to neuroendocrine tumors and other SSTR2-expressing malignancies. Pharmaceutical R&D laboratories, contract development and manufacturing organizations (CDMOs), and nuclear medicine radiopharmacies rely on IRL-1620 CAS NO 142569-99-1 for preclinical validation, GMP-grade radiolabeling process development, and clinical supply chain support.

Application

• Preclinical development of targeted alpha therapy (TAT) agents for neuroendocrine tumors (NETs)
• Radiolabeling platform for ²¹³Bi, ²²⁵Ac, and ¹⁷⁷Lu in theranostic workflows
• Lead compound optimization in SSTR2-targeted drug conjugate programs
• GMP-compliant synthesis of clinical trial materials under FDA IND and EMA CTA frameworks
• Biodistribution and dosimetry studies in rodent and non-human primate models
• Stability assessment of DOTA-conjugated peptides under radiolabeling conditions
• Reference standard for HPLC and LC-MS/MS method validation in radiopharmaceutical QC labs
• Process analytical technology (PAT) development for real-time monitoring of conjugation efficiency

Basic Information

Product Name	IRL-1620
CAS No.	142569-99-1
Molecular Formula	C₇₄H₁₀₅N₂₃O₂₀
Molecular Weight	1638.75 g/mol
Synonyms	DOTA-D-Phe¹-Tyr³-octreotate; DOTA-[D-Phe¹,Tyr³]octreotate; DOTA-TATE analog; IRL-1620 (non-radiolabeled); DOTA-DPhe-Tyr-Octreotate; DOTA-D-Phe¹-Tyr³-octreotate hydrate; DOTA-DPhe¹-Tyr³-Octreotate; DOTA-D-Phe¹-Tyr³-octreotate (free acid)
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 conform to ICH Q5, Q7, and Q9 guidelines, with full traceability from raw materials to final release. Testing includes identity (HPLC, MS, IR), purity (HPLC-UV ≥98.5%), residual solvents (GC), water content (Karl Fischer), and endotoxin levels (<0.5 EU/mg). GMP-compliant manufacturing is conducted in ISO 9001- and ISO 13485-certified facilities.

Storage

Preserve in a tightly closed container, protected from light. Store at 2–8 °C under inert atmosphere (argon or nitrogen) to prevent degradation. Due to its hygroscopic nature, maintain low-humidity conditions (<30% RH) and avoid repeated exposure to ambient air. Handle in a controlled environment with desiccated glove boxes or nitrogen-purged vials during weighing and formulation.

Specification

Item	Specification
Appearance	White to off-white lyophilized powder
Identification (HPLC)	Retention time matches reference standard
Identification (MS)	[M+H]⁺ ion at m/z 1639.8 ± 0.5
Assay (HPLC-UV)	≥98.5%
Related Substances	Single impurity ≤0.5%; Total impurities ≤1.5%
Water Content (KF)	≤5.0%
Residual Solvents (GC)	MeOH ≤3000 ppm; Acetonitrile ≤410 ppm; DCM ≤600 ppm
Endotoxins	<0.5 EU/mg
pH (5 mg/mL in water)	4.5–6.5

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