Description

Benzocaine Impurity D CAS NO 1333-08-0 is a high-purity reference standard critical for pharmaceutical quality control and analytical research. This compound serves as a key specified impurity in the pharmacopeial assessment of Benzocaine, an essential local anesthetic. Its availability is vital for manufacturers and analytical laboratories to ensure product safety, efficacy, and regulatory compliance. This standard is primarily used by professionals in pharmaceutical development, quality assurance, and regulatory affairs.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Benzocaine Impurity D in active pharmaceutical ingredient (API) and finished product testing.
• Method Development and Validation: Essential for developing and validating analytical methods, particularly High-Performance Liquid Chromatography (HPLC) and related techniques, in compliance with ICH guidelines.
• Quality Control (QC) Testing: A critical component in the QC release testing of Benzocaine to monitor and control impurity levels as per USP, EP, or other pharmacopeial monographs.
• Stability Studies: Employed to track the formation and growth of this specific impurity during forced degradation and long-term stability studies of Benzocaine formulations.
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing definitive impurity characterization data.
• Research and Development: Used in R&D laboratories to study the degradation pathways and impurity profile of Benzocaine and related ester-type anesthetics.

Basic Information

Product Name	Benzocaine Impurity D
CAS No.	1333-08-0
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	4-Aminobenzoic Acid Ethyl Ester Impurity D; Benzocaine Related Compound D; Ethyl 4-Aminobenzoate Impurity D; USP Benzocaine Impurity D; EP Impurity D of Benzocaine; Benzocaine Specified Impurity D; Amino Benzoic Acid Ethyl Ester Impurity D
EINECS	Contact for details

Quality Control

Every batch of Benzocaine Impurity D is manufactured and controlled under a strict quality management system. The material is characterized and qualified using advanced analytical techniques to ensure identity, purity, and suitability for use as a reference standard. A comprehensive Certificate of Analysis (COA) is provided with each lot, detailing results from tests such as HPLC purity, related substances, and identification. Our quality commitment aligns with the standards expected for pharmaceutical impurity standards.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. Keep the container sealed to protect the material from moisture and atmospheric contaminants.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms
Identification (HPLC)	Conforms
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Meets requirement
Residual Solvents (GC)	Meets ICH limits

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