Description

Butylhydroxyanisole Impurity 2 (3-tert-Butyl-4-Hydroxyanisole-D3) is a deuterated isotopologue of a key synthetic intermediate and degradation product related to the common antioxidant Butylated Hydroxyanisole (BHA). This compound is of critical importance for use as a certified reference standard in analytical chemistry, enabling precise quantification and method validation. It is primarily required by pharmaceutical quality control laboratories, analytical research institutions, and food safety testing facilities to ensure product purity and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Used as a high-purity certified material for the identification and quantification of related substances and degradation products in BHA-containing drug formulations and active pharmaceutical ingredients (APIs).
• Analytical Method Development & Validation: Serves as a critical internal standard or calibration standard in chromatographic methods (HPLC, GC-MS, LC-MS) to improve accuracy and reproducibility in complex matrices.
• Food & Cosmetic Safety Testing: Employed in the analysis of antioxidant additives to monitor impurity profiles and ensure compliance with food-grade (FCC) and cosmetic safety regulations.
• Metabolic & Pharmacokinetic Studies: The deuterium labeling makes it valuable as a stable isotope-labeled tracer in mass spectrometry-based studies investigating the absorption, distribution, metabolism, and excretion (ADME) of related phenolic compounds.
• Regulatory Compliance & Quality Assurance: Essential for generating data to meet stringent regulatory requirements from agencies like the FDA, EMA, and ICH for impurity profiling and control.

Basic Information

Product Name	Butylhydroxyanisole Impurity 2 (3-tert-Butyl-4-Hydroxyanisole-D3)
CAS No.	85013-37-2
Molecular Formula	C11H13D3O2
Molecular Weight	183.25 g/mol (approx.)
Synonyms	3-tert-Butyl-4-hydroxyanisole-d3; BHA Impurity 2-d3; 2-tert-Butyl-4-methoxyphenol-d3; 3-(1,1-Dimethylethyl)-4-methoxyphenol-d3; Deuterated BHA Impurity; tert-Butylhydroxyanisole-d3; 4-Methoxy-2-tert-butylphenol-d3; 3-tert-Butyl-4-methoxyphenol-d3
EINECS	Contact for details

Quality Control

Every batch of our Butylhydroxyanisole Impurity 2 is manufactured and analyzed under strict quality management systems. The product is characterized using advanced spectroscopic and chromatographic techniques to ensure identity, purity, and isotopic enrichment. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for assay, isotopic purity, and related substances. Our quality commitment aligns with the standards expected for high-grade reference materials used in regulated industries.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). The compound is light-sensitive (store away from light). Keep the container tightly sealed in a dry environment to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (NMR)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Isotopic Purity (D-content)	≥ 98 atom % D
Related Substances (HPLC)	Individual impurity ≤ 0.5%
Total Impurities	≤ 2.0%
Residual Solvents (GC)	Complies with ICH limits

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