Description

Zolmitriptan Related Compound F is a high-purity chemical reference standard, essential for analytical research and quality control in pharmaceutical development. This compound serves as a critical impurity marker for ensuring the safety and efficacy of the active pharmaceutical ingredient Zolmitriptan. It is primarily required by analytical laboratories, quality assurance departments, and research institutions within the pharmaceutical and fine chemical sectors for method validation and regulatory compliance.

Application

• Primary use as a pharmaceutical reference standard for analytical method development and validation.
• Critical impurity identification and quantification in Zolmitriptan API (Active Pharmaceutical Ingredient) batches.
• Quality control testing to meet pharmacopeial standards (e.g., USP, EP, ICH guidelines).
• Stability studies and forced degradation studies of Zolmitriptan formulations.
• Calibration of analytical instruments such as HPLC, UPLC, and LC-MS systems.
• Supporting regulatory filings (e.g., ANDA, NDA) by providing impurity characterization data.
• Research and development of generic versions of Zolmitriptan-based migraine treatments.

Basic Information

Product Name	Zolmitriptan Related Compound F
CAS No.	1350928-05-0
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Zolmitriptan Impurity F; Zolmitriptan Related Substance F; Zolmitriptan EP Impurity F; Zolmitriptan USP Related Compound F; (4S)-4-[[3-[2-(Dimethylamino)ethyl]-1H-indol-5-yl]methyl]-1,3-oxazolidin-2-one Impurity; Zolmitriptan Process Impurity; Zolmitriptan Degradation Product
EINECS	Contact for details

Quality Control

Our Zolmitriptan Related Compound F is manufactured under strict quality systems to ensure the highest standards of purity and consistency. Each batch is subjected to comprehensive analytical testing, including chromatographic purity and structural confirmation, to meet the stringent requirements for pharmaceutical reference materials. Certificates of Analysis (COA) with detailed chromatographic data are provided and can be tailored to support specific pharmacopeial (USP/EP) or ICH regulatory guidelines.

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 must be kept in a desiccated environment to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 1.0%

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