Description

Ropivacaine Related Compound B (50 Mg) ((R)-(+)-1-Propylpiperidine-2-Carboxylic Acid (2,6-Dimethylphenyl)-Amide Hydrochloride Monohydrate) is a high-purity chemical reference standard, essential for analytical and quality control processes in pharmaceutical development. This compound, with CAS number 112773-90-7, serves as a critical impurity marker and process intermediate for the synthesis and validation of the local anesthetic Ropivacaine. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and research institutions focused on method development, regulatory compliance, and ensuring the purity and safety of active pharmaceutical ingredients (APIs).

Application

• Pharmaceutical Impurity Profiling and Control: Used as a certified reference standard for the identification and quantification of specific impurities in Ropivacaine API and finished drug products.
• Analytical Method Development and Validation: Essential for developing, calibrating, and validating chromatographic methods (HPLC, GC) and spectroscopic analyses in QC laboratories.
• Pharmacological and Toxicological Research: Employed in studies investigating the metabolism, degradation pathways, and safety profile of Ropivacaine and related compounds.
• Process Chemistry and Synthesis: Acts as a key intermediate or reference point in the research-scale synthesis and optimization of Ropivacaine manufacturing processes.
• Regulatory Compliance and Documentation: Supports regulatory filings (e.g., with FDA, EMA) by providing characterized impurity standards for stability studies and specification setting.
• Quality Assurance Testing: Integral for in-house quality control testing to ensure batch-to-batch consistency and adherence to strict pharmacopeial standards.

Basic Information

Product Name	Ropivacaine Related Compound B (50 Mg) ((R)-(+)-1-Propylpiperidine-2-Carboxylic Acid (2,6-Dimethylphenyl)-Amide Hydrochloride Monohydrate)
CAS No.	112773-90-7
Molecular Formula	C17H28N2O • HCl • H2O
Molecular Weight	328.88 g/mol (Monohydrate Hydrochloride)
Synonyms	(R)-(+)-1-Propyl-2',6'-Pipecoloxylidide Hydrochloride Monohydrate; (R)-1-Propyl-2,6-pipecoloxylidide HCl Monohydrate; (R)-(+)-N-(2,6-Dimethylphenyl)-1-propyl-2-piperidinecarboxamide Hydrochloride Monohydrate; Ropivacaine Impurity B; Ropivacaine Related Substance B; Ropivacaine EP Impurity B; (2R)-1-Propyl-N-(2,6-dimethylphenyl)piperidine-2-carboxamide hydrochloride monohydrate
EINECS	Contact for details

Quality Control

Our Ropivacaine Related Compound B is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity, identity confirmation by IR and NMR, and residual solvent analysis, to ensure it meets the high standards required for pharmaceutical reference materials. A detailed Certificate of Analysis (COA) is provided with each shipment, confirming compliance with in-house specifications aligned with ICH guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, 15-25°C (59-77°F), in a dry environment. The product is light-sensitive and should be handled accordingly to maintain stability.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	≥ 98.0%
Water Content (KF)	4.5% - 6.5%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 1.0%
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.