Description

Tramadol Ep Impurity-C CAS NO 66170-31-8 is a specified impurity and reference standard used in the analytical profiling of the pharmaceutical active ingredient Tramadol. This compound is critical for ensuring the quality, safety, and efficacy of Tramadol-based drug products by enabling accurate identification and quantification of related substances. It is an essential material for pharmaceutical manufacturers, analytical laboratories, and regulatory bodies focused on quality control and compliance with pharmacopeial standards such as USP and EP.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Tramadol Hydrochloride active pharmaceutical ingredient (API) and finished dosage forms.
• Analytical Method Development & Validation: Serves as a critical component in developing and validating High-Performance Liquid Chromatography (HPLC) and other chromatographic methods for impurity profiling.
• Quality Control & Assurance (QC/QA): Employed in routine batch release testing to monitor and control impurity levels, ensuring compliance with International Conference on Harmonisation (ICH) Q3A/B guidelines.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) to demonstrate product purity.
• Stability Studies: Used to track the formation of degradation products in Tramadol formulations under various stress conditions (e.g., heat, light, humidity).
• Pharmacopeial Testing: Essential for testing against the specifications outlined in the European Pharmacopoeia (EP) and United States Pharmacopeia (USP) monographs for Tramadol.

Basic Information

Product Name	Tramadol Ep Impurity-C
CAS No.	66170-31-8
Molecular Formula	C16H25NO2
Molecular Weight	263.38 g/mol
Synonyms	(1R,2R)-2-[(Dimethylamino)methyl]-1-(3-methoxyphenyl)cyclohexanol; Tramadol Impurity C (EP); Tramadol Related Compound C; Tramadol European Pharmacopoeia Impurity C; (1R,2R)-Tramadol; Tramadol Impurity C (USP); Tramadol EP Imp C; 1-(3-Methoxyphenyl)-2-[(dimethylamino)methyl]cyclohexan-1-ol (1R,2R)-form
EINECS	Contact for details

Quality Control

Every batch of Tramadol Ep Impurity-C is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced techniques like HPLC, GC, and NMR to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results, including chromatographic purity, water content, and residual solvents. We support compliance with cGMP, ICH, USP, and EP guidelines.

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 under dry conditions to prevent degradation. For long-term storage, consider storing under an inert atmosphere in a desiccator.

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)	Any individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
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.