Description

Fipronil Impurity 2 is a designated reference standard used for analytical and quality control purposes in the pharmaceutical and agrochemical industries. This compound is critical for ensuring the purity, safety, and regulatory compliance of the active pharmaceutical ingredient (API) Fipronil and its related formulations. It is an essential material for research and development laboratories, quality assurance units, and manufacturers focused on producing high-grade Fipronil products. The compound is supplied with a high level of purity to meet the stringent demands of modern analytical methods.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of Fipronil Impurity 2 in Fipronil API batches, ensuring compliance with ICH guidelines.
• Analytical Method Development & Validation: Serves as a critical component in developing and validating HPLC, GC, and LC-MS methods for impurity profiling.
• Quality Control & Assurance: Employed in routine QC testing to monitor impurity levels and maintain batch-to-batch consistency in Fipronil production.
• Regulatory Compliance & Documentation: Essential for preparing regulatory submission dossiers (e.g., for FDA, EMA) that require detailed impurity characterization data.
• Stability Studies: Used to track the formation and levels of this specific impurity during forced degradation and long-term stability testing of Fipronil.
• Research & Development: Aids in synthetic route optimization and impurity fate and tolerance studies during process development.

Basic Information

Product Name	Fipronil Impurity 2
CAS No.	120068-81-7
Molecular Formula	C₁₂H₄Cl₂F₆N₄OS
Molecular Weight	437.14 g/mol
Synonyms	5-Amino-1-[2,6-dichloro-4-(trifluoromethyl)phenyl]-4-[(trifluoromethyl)sulfinyl]-1H-pyrazole-3-carbonitrile; Fipronil Sulfoxide; Fipronil Impurity B; Fipronil Metabolite Sulfoxide; MB 46136; MB-46136; (RS)-5-Amino-1-(2,6-dichloro-α,α,α-trifluoro-p-tolyl)-4-trifluoromethylsulfinylpyrazole-3-carbonitrile
EINECS	Contact for details

Quality Control

Every batch of Fipronil Impurity 2 is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical testing, including HPLC, GC, and NMR, to ensure high purity and accurate identification, meeting the standards required for reference materials. A comprehensive Certificate of Analysis (COA) detailing purity, assay, and impurity profile is provided with each shipment to support your regulatory and quality needs.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. This material is light-sensitive (store away from light) and hygroscopic (moisture-sensitive). For long-term storage, consider storing under an inert atmosphere to prevent degradation.

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)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 0.5% w/w

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