Description

Diroximel Fumarate Impurity 2 is a designated impurity of the active pharmaceutical ingredient diroximel fumarate, a medication used in the treatment of multiple sclerosis. This compound is critical for pharmaceutical research and development, serving as a key reference standard for analytical method development, stability studies, and regulatory compliance. It is essential for quality control laboratories, analytical chemists, and manufacturers involved in the production and validation of diroximel fumarate drug substances and products.

Application

• Primary use as a pharmaceutical reference standard for analytical testing.
• Critical for impurity profiling and identification in diroximel fumarate API and finished dosage forms.
• Method development and validation for HPLC, UPLC, and other chromatographic techniques.
• Stability indicating studies to monitor degradation pathways.
• Supporting regulatory filings (e.g., ANDA, NDA) by providing impurity characterization data.
• Quality control and batch release testing in GMP manufacturing environments.
• Used in research to understand the chemical behavior and pharmacokinetics of related compounds.

Basic Information

Product Name	Diroximel Fumarate Impurity 2
CAS No.	2101811-41-8
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	BIIB098 Impurity 2; ALKS 8700 Impurity 2; (2E)-But-2-enedioic acid - 1-(2-ethylbutyl) 4-methyl ester impurity; Diroximel Fumarate Related Compound 2; Monomethyl fumarate 2-ethylbutyl ester impurity; Vumerity Impurity 2; Fumaric acid, mono(2-ethylbutyl) ester, methyl ester impurity
EINECS	Contact for details

Quality Control

Our high-purity reference standards are manufactured under strict quality systems. Each batch of Diroximel Fumarate Impurity 2 is subjected to comprehensive analytical testing, including HPLC for purity and spectroscopic methods for structural confirmation, to ensure identity, potency, and consistency. Certificates of Analysis (COA) with detailed chromatograms and spectral data are provided to support your GMP and research requirements.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and should be handled under dry conditions to maintain stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unspecified impurity: ≤ 1.0% Total impurities: ≤ 5.0%
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.