Description

Remifentanil Impurity 1 (Rtf-02) is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the potent opioid analgesic, Remifentanil. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling studies.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material for the identification and quantification of specific impurities in Remifentanil API and finished drug products.
• Analytical Method Development: Serves as a critical standard for developing and validating HPLC, UPLC, and GC methods to monitor process-related impurities.
• Quality Control & Assurance (QC/QA): Essential for in-house quality control testing to ensure batch-to-batch consistency and compliance with pharmacopeial standards (USP, EP).
• Stability Studies: Employed in forced degradation and long-term stability studies of Remifentanil to understand impurity formation pathways.
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDA).
• Research & Development: Used in synthetic chemistry R&D for studying the degradation pathways and metabolism of Remifentanil.

Basic Information

Product Name	Remifentanil Impurity 1 (Rtf-02)
CAS No.	938184-94-2
Molecular Formula	C20H28N2O5
Molecular Weight	376.45 g/mol
Synonyms	Remifentanil Related Compound A; Remifentanil Impurity A; 1-(2-Methoxycarbonylethyl)-4-(phenylpropionylamino)piperidine-4-carboxylic acid methyl ester; Methyl 1-(2-methoxy-2-oxoethyl)-4-[(1-oxo-3-phenylpropyl)amino]piperidine-4-carboxylate; GI87084B Impurity; RFT-02; Ultiva Impurity.
EINECS	Contact for details

Quality Control

Every batch of Remifentanil Impurity 1 (Rtf-02) is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity testing using advanced analytical techniques such as HPLC, GC-MS, and NMR to ensure compliance with pharmacopeial and customer-specific standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment.

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 material is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity ≤ 0.5% Total impurities ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0% w/w

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