Description

Ubidecarenone Impurity 2 (Coenzyme Q10) is a specified impurity used as a critical reference standard in the analytical profiling of Coenzyme Q10 (Ubidecarenone). This compound is essential for ensuring the purity, safety, and efficacy of pharmaceutical products containing CoQ10, a vital cofactor in cellular energy production. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and quality control departments for method development, validation, and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of related substances in Coenzyme Q10 active pharmaceutical ingredients (APIs) and finished dosage forms.
• Analytical Method Development & Validation: Essential for developing and validating HPLC, UPLC, or GC methods to monitor impurities during stability studies and release testing.
• Quality Control & Assurance: Serves as a system suitability component and a calibrant to ensure the accuracy and precision of impurity profiling in QC laboratories.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., for FDA, EMA) by providing characterized material for impurity identification as per ICH Q3A(R2) and Q3B(R2) guidelines.
• Research & Development: Utilized in R&D for studying the degradation pathways, stability, and metabolism of Coenzyme Q10.
• Contract Manufacturing Organizations (CMOs): Employed by CMOs to guarantee batch-to-batch consistency and meet client specifications for impurity limits.

Basic Information

Product Name	Ubidecarenone Impurity 2 (Coenzyme Q10)
CAS No.	65085-29-2
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Coenzyme Q10 Impurity 2; Ubidecarenone Related Compound 2; CoQ10 Impurity 2; 2,3-Dimethoxy-5-methyl-6-(3-methylbut-2-en-1-yl)benzene-1,4-diol (proposed); Coenzyme Q10 Degradant; Ubiquinone-10 Impurity 2
EINECS	Contact for details

Quality Control

Our Ubidecarenone Impurity 2 is manufactured under strict quality systems suitable for use as a reference standard. Each batch undergoes rigorous analytical testing, including HPLC purity analysis and structural confirmation (e.g., by NMR and MS), to ensure high purity and accurate characterization. Certificates of Analysis (COA) with detailed chromatographic data are provided to support your regulatory and quality requirements.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive); ensure the container is sealed tightly after each use to prevent degradation from atmospheric moisture.

Specification

Item	Specification
Appearance	Yellow to orange powder or solid
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Complies with specification
Water Content (KF)	≤ 5.0%

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