Description

Buprenorphine Related Compound A Cii (25 Mg) (21-[3-(1-Propenyl)]-7Alpha-[(S)-1-Hydroxy-1,2,2-Trimethylpropyl]-6,14-Endo-Ethano-6,7,8,14-Tetrahydrooripavine) is a high-purity reference standard and pharmaceutical intermediate critical for analytical and research purposes. This compound is essential for ensuring the quality, safety, and regulatory compliance of pharmaceutical products and forensic analyses. It is primarily needed by pharmaceutical R&D laboratories, quality control (QC) departments, and forensic science institutions engaged in method development, impurity profiling, and substance identification.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the quantitative and qualitative analysis of buprenorphine and related substances in drug products and active pharmaceutical ingredients (APIs).
• Impurity Profiling and Identification: Serves as a critical impurity marker (Related Substance A) in the stability testing and quality control of buprenorphine-based medications to meet pharmacopeial standards (e.g., USP, EP).
• Forensic and Clinical Toxicology: Employed as an analytical standard in forensic laboratories for the precise identification and quantification of buprenorphine and its metabolites in biological samples.
• Method Development and Validation: Essential for developing, calibrating, and validating chromatographic methods (HPLC, LC-MS, GC-MS) in analytical research.
• Pharmacological Research: Used in studies investigating the structure-activity relationships (SAR) of opioid receptor ligands and the metabolic pathways of buprenorphine.
• Regulatory Compliance and Documentation: Supports regulatory filings (e.g., with FDA, EMA) by providing definitive proof of impurity identity and concentration for drug master files (DMFs).

Basic Information

Product Name	Buprenorphine Related Compound A Cii (25 Mg) (21-[3-(1-Propenyl)]-7Alpha-[(S)-1-Hydroxy-1,2,2-Trimethylpropyl]-6,14-Endo-Ethano-6,7,8,14-Tetrahydrooripavine)
CAS No.	457071-73-7
Molecular Formula	C29H41NO4
Molecular Weight	467.64 g/mol
Synonyms	Buprenorphine Related Compound A; Buprenorphine Impurity A; 21-(3-Propen-1-yl)-7α-[(1S)-1-hydroxy-1,2,2-trimethylpropyl]-6,14-endo-ethano-6,7,8,14-tetrahydrooripavine; 21-(3-Propenyl)-7α-[(1S)-1-hydroxy-1,2,2-trimethylpropyl]-6,14-endo-ethanotetrahydrooripavine; Buprenorphine EP Impurity A; Buprenorphine USP Related Compound A; UNII-CII6Q55S0M
EINECS	Contact for details

Quality Control

Our Buprenorphine Related Compound A Cii is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including chromatographic purity assays and structural confirmation, to ensure it meets the exacting standards required for reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing purity, identity, and impurity profiles. We support compliance with USP, EP, and ICH guidelines for impurities in pharmaceutical substances.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15°C and 25°C (59°F and 77°F). The product is light-sensitive and should be handled under appropriate conditions to prevent degradation. For long-term storage, consider storing desiccated at 2-8°C.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 0.5% w/w
Assay (on dried basis)	97.0% - 103.0%

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