Description

Phenyltoloxamine Related Compound A is a high-purity chemical reference standard and synthetic intermediate of significant importance in pharmaceutical development and quality control. Its primary value lies in its critical role as a well-characterized impurity or degradation product for the validation of analytical methods and the establishment of regulatory compliance for the antihistamine, Phenyltoloxamine. This compound is essential for research laboratories, analytical service providers, and pharmaceutical manufacturers engaged in API synthesis, impurity profiling, and stability studies to ensure product safety and efficacy.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for HPLC, GC, or LC-MS analysis in method development and validation.
• Analytical Research: Used in comparative studies for the identification and quantification of related substances in active pharmaceutical ingredients (APIs).
• Process Chemistry: Acts as a key intermediate or a marker compound in the synthesis and optimization of Phenyltoloxamine and its derivatives.
• Quality Assurance/Control (QA/QC): Critical for impurity profiling, batch release testing, and stability-indicating assays to meet ICH and pharmacopeial guidelines.
• Regulatory Compliance: Supports the preparation of regulatory submission documents (e.g., for FDA, EMA) by providing characterized impurity data.
• Academic & Contract Research: Utilized in university and CRO settings for pharmacological research and analytical method development services.

Basic Information

Product Name	Phenyltoloxamine Related Compound A
CAS No.	75859-72-2
Molecular Formula	C₁₇H₂₁NO
Molecular Weight	255.36 g/mol
Synonyms	N,N-Dimethyl-2-[2-(phenylmethyl)phenoxy]ethanamine; 2-[2-(Benzyl)phenoxy]-N,N-dimethylethanamine; Phenyltoloxamine Impurity A; Phenyltoloxamine EP Impurity A; Phenyltoloxamine Related Substance A; 1-(2-(Benzyl)phenoxy)-N,N-dimethyl-2-ethanamine; α-(2-(Dimethylamino)ethoxy)-o-benzyltoluene
EINECS	Contact for details

Quality Control

Our Phenyltoloxamine Related Compound A is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including identification (IR, NMR), purity assay (HPLC), and control of specified impurities, to ensure it meets the stringent requirements for use as a reference material. A detailed Certificate of Analysis (COA) providing batch-specific data is supplied with every shipment to support your regulatory and quality documentation needs.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry, and well-ventilated area at controlled room temperature (15-25°C). Keep the container tightly sealed to protect from moisture.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unspecified impurity ≤ 0.5%
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.