Description

trans-Tramadol (Tramadol Impurity) is a stereoisomeric impurity of the centrally acting analgesic, Tramadol hydrochloride. This compound is critical for pharmaceutical research and development, serving as a key reference standard in the analytical profiling and quality control of Tramadol-based drug substances and products. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies to ensure drug purity, safety, and compliance with stringent pharmacopeial standards.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of the trans-isomer impurity in Tramadol API and finished dosage forms.
• Analytical Method Development & Validation: Essential for developing, calibrating, and validating chromatographic methods (HPLC, GC) to monitor stereochemical purity.
• Quality Control & Assurance (QC/QA): A critical component in impurity profiling to ensure batch-to-batch consistency and compliance with ICH Q3A/B guidelines.
• Regulatory Submissions: Supports regulatory filings (e.g., for FDA, EMA) by providing necessary impurity data for drug master files (DMFs) and investigational new drug (IND) applications.
• Stability Studies: Employed to track the formation of degradation products related to the trans-isomer during forced degradation and long-term stability testing of drug products.
• Research on Pharmacokinetics & Metabolism: Used in studies to understand the metabolic pathways and pharmacokinetic behavior of Tramadol stereoisomers.

Basic Information

Product Name	trans-Tramadol (Tramadol Impurity)
CAS No.	371977-05-8
Molecular Formula	C16H25NO2
Molecular Weight	263.38 g/mol
Synonyms	(1R,2R)-2-[(Dimethylamino)methyl]-1-(3-methoxyphenyl)cyclohexanol; (1R,2R)-Tramadol; trans-(1R,2R)-Tramadol; Tramadol Impurity F (trans-isomer); Tramadol Related Compound F; (+)-trans-Tramadol; (R,R)-Tramadol; UNII-1O4Y1C2T2I
EINECS	Contact for details

Quality Control

Our trans-Tramadol (Tramadol Impurity) CAS NO 371977-05-8 is manufactured and handled under strict quality management systems. Each batch is subjected to rigorous analytical testing, including advanced chromatographic techniques, to ensure high chemical purity and accurate identification. Certificates of Analysis (COA) are provided, detailing comprehensive specifications and test results in alignment with current industry and regulatory expectations for reference standards.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. For long-term storage, consider storing at 2-8°C to ensure maximum stability.

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

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