Description

Treprostinil Acyl-β-D-Glucuronide is a major, pharmacologically relevant metabolite of the prostacyclin analog treprostinil. This compound is of critical importance for pharmaceutical research and development, particularly in the study of drug metabolism, pharmacokinetics (PK), and bioanalytical method validation. It is primarily needed by pharmaceutical companies, contract research organizations (CROs), and academic institutions engaged in the development and regulatory submission of treprostinil-based therapies for pulmonary arterial hypertension (PAH).

Application

• Reference Standard for Bioanalysis: Serves as a certified primary standard for the quantification of treprostinil metabolites in biological matrices (plasma, serum, urine) using LC-MS/MS and HPLC methods.
• Pharmacokinetic & Metabolism Studies: Essential for investigating the metabolic pathways, clearance rates, and half-life of treprostinil in preclinical and clinical research.
• Impurity Profiling & Drug Substance Characterization: Used to identify, qualify, and control glucuronidated impurities in treprostinil active pharmaceutical ingredient (API) batches.
• Regulatory Compliance & Submission: Supports regulatory filings (e.g., with FDA, EMA) by providing definitive characterization data for drug metabolites as required by ICH M3(R2) and ICH S3A guidelines.
• In-vitro Metabolism Assays: Employed in studies with hepatocytes or microsomal fractions to understand enzyme kinetics and potential drug-drug interactions.
• Method Development & Validation: Critical for developing and validating robust, GLP-compliant analytical methods for metabolite monitoring.

Basic Information

Product Name	Treprostinil Acyl-β-D-Glucuronide
CAS No.	148916-53-4
Molecular Formula	C31H43NO11
Molecular Weight	605.68 g/mol
Synonyms	Treprostinil Acyl Glucuronide; Treprostinil 1-O-β-Acyl Glucuronide; 15(S)-Hydroxy-16-(3,4,5-trimethoxyphenoxy)-3,7,11,13-tetradecatetraenoic Acid Acyl-β-D-Glucuronide; UNII-9G2C4S4M8B; Remodulin Metabolite; UT-15 Glucuronide; Prostacyclin PG12 Analogue Glucuronide; Beraprost Related Compound Glucuronide (structural analog)
EINECS	Contact for details

Quality Control

Our Treprostinil Acyl-β-D-Glucuronide is manufactured under strict quality management systems. Each batch is subjected to rigorous identity confirmation, purity analysis, and impurity profiling using advanced analytical techniques including HPLC, LC-MS, and NMR. We provide comprehensive Certificates of Analysis (COA) with detailed chromatographic data, ensuring traceability and compliance with research and regulatory standards. Materials are suitable for use as certified reference standards.

Storage

Preserve in a tightly closed container, protected from light. Store at -20°C or below in a freezer. This product is hygroscopic (moisture-sensitive) and must be handled under anhydrous conditions to maintain stability and purity. Allow the sealed vial to equilibrate to room temperature before opening to prevent condensation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (MS)	Mass spectrum conforms to structure
Purity (HPLC)	≥ 95.0% (Area Percent)
Assay (HPLC)	≥ 90.0% (by weight against certified reference)
Water Content (KF)	≤ 5.0% w/w
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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