Description

Norbuprenorphine is a key pharmaceutical intermediate and metabolite of buprenorphine, a medication used in the treatment of opioid use disorder and pain. This compound is of critical importance for analytical and research purposes, particularly in the fields of forensic toxicology, clinical pharmacology, and drug metabolism studies. It is primarily utilized by pharmaceutical R&D laboratories, reference standard manufacturers, and diagnostic companies requiring high-purity materials for method development, calibration, and quality control.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the quantitative and qualitative analysis of buprenorphine and its metabolites in biological matrices.
• Forensic Toxicology: Essential for developing and validating LC-MS/MS, GC-MS, and immunoassay methods used in drug testing and post-mortem analyses.
• Clinical Research: Used in pharmacokinetic and pharmacodynamic studies to understand the metabolism, distribution, and elimination of buprenorphine-based therapies.
• Diagnostic Kit Manufacturing: A critical component in the production of calibrators and controls for in-vitro diagnostic (IVD) assays targeting opioid metabolites.
• Metabolite Identification: Employed in drug discovery and development to map metabolic pathways and identify potential active or toxic metabolites.
• Academic Research: Used in university and institutional labs studying opioid receptor interactions, neuropharmacology, and addiction science.

Basic Information

Product Name	Norbuprenorphine
CAS No.	78715-23-8
Molecular Formula	C₂₀H₂₇NO₄
Molecular Weight	345.44 g/mol
Synonyms	Nor-buprenorphine; 17-(Cyclopropylmethyl)-4,5α-epoxy-3,14-dihydroxymorphinan-6-one; 6-Desoxy-6-oxonorbuprenorphine; Buprenorphine Impurity C; Buprenorphine Metabolite; BPN Metabolite; UNII-9KQ0K8JZ61
EINECS	Contact for details

Quality Control

Our Norbuprenorphine is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including identification by spectroscopic methods (IR, NMR, MS), purity determination by HPLC, and control of specified impurities. We provide full traceability and Certificates of Analysis (COA) detailing all test results, ensuring compliance with the stringent requirements of reference standard and pharmaceutical intermediate applications.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and should be handled in a low-humidity environment to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 1.0%
Heavy Metals	≤ 20 ppm

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