Description

Naloxegol is a peripherally acting mu-opioid receptor antagonist developed for the management of opioid-induced constipation (OIC) in adult patients with chronic non-cancer pain. It is valued for its selective peripheral action, minimizing central nervous system effects while maintaining gastrointestinal efficacy. Pharmaceutical manufacturers, contract development and manufacturing organizations (CDMOs), and clinical research suppliers rely on high-purity naloxegol for formulation development, stability studies, and reference standard applications. Naloxegol CAS NO 854601-70-0 is supplied under strict quality governance to support regulatory submissions and GMP-compliant production.

Application

• Active pharmaceutical ingredient (API) for oral tablet formulations targeting opioid-induced constipation
• Reference standard in pharmacopeial testing (USP, EP) and method validation for HPLC and LC-MS assays
• Raw material for stability-indicating assay development and forced degradation studies
• Key compound in preclinical and clinical pharmacokinetic (PK) and drug–drug interaction (DDI) investigations
• Component in analytical calibration standards for bioanalytical laboratories supporting Phase II–IV trials
• Starting material or intermediate in synthetic route optimization for scalable API manufacturing
• Quality control benchmark for identity, purity, and assay verification across batch releases

Basic Information

Product Name	Naloxegol
CAS No.	854601-70-0
Molecular Formula	C31H41NO9
Molecular Weight	571.66 g/mol
Synonyms	Naloxegol; Naloxegol monohydrate (common hydrate form); Naloxegol hydrate; Naloxegol hemihydrate; Naloxegol oxalate; Naloxegol hydrochloride; 6α-[(2-Aminoethoxy)methyl]-6,14-endo-ethanotetrahydrothebaine; MK-0677; MK-677; LY-2444296; LY2444296; 6α-(2-Aminoethoxymethyl)-6,14-endo-ethanotetrahydrothebaine; Naloxone-3-O-β-D-glucuronide derivative
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, Q6A, and Q7 guidelines, with full traceability from synthesis through purification and final packaging. Testing includes identity (IR, HPLC, MS), assay (HPLC), related substances (HPLC), residual solvents (GC), heavy metals (USP <231>), and water content (Karl Fischer). Complies with USP-NF and European Pharmacopoeia monograph requirements where applicable.

Storage

Preserve in a tightly closed container, protected from light. Store at 15–25°C in a dry, well-ventilated area. Due to its hygroscopic nature, minimize exposure to ambient humidity; desiccant use is recommended during handling and long-term storage.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to reference standard
Identification (HPLC)	Retention time matches reference standard
Assay	98.5% – 101.0% (on anhydrous basis)
Related Substances	≤ 0.5% total impurities; individual impurity ≤ 0.1%
Residual Solvents	Meets ICH Q3C limits (e.g., methanol ≤ 3000 ppm, acetone ≤ 5000 ppm)
Water Content (KF)	≤ 5.0% (monohydrate form typical)
Heavy Metals	≤ 10 ppm
Microbial Limits	Complies with USP <61> (Total Aerobic Microbial Count ≤ 100 CFU/g; absence of specified organisms)

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