Description

Bromisoval Impurity 1 is a specified impurity of the sedative-hypnotic drug Bromisoval (Bromovalerylurea). This high-purity reference standard is critical for analytical method development, validation, and quality control in pharmaceutical manufacturing. It is essential for researchers and quality assurance professionals in the pharmaceutical industry who require reliable materials for ensuring drug safety, purity, and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of Bromisoval impurities.
• Analytical Method Development: Used in developing and optimizing HPLC, UPLC, or GC methods for impurity profiling.
• Quality Control & Assurance (QC/QA): Critical for routine batch testing of active pharmaceutical ingredients (APIs) and finished drug products to meet ICH guidelines.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., FDA, EMA) by providing data for impurity identification and qualification.
• Stability Studies: Employed to monitor impurity levels in drug substances and products under various storage conditions over time.
• Research & Development: Used in synthetic chemistry research to understand degradation pathways and to synthesize pure batches of the active compound.

Basic Information

Product Name	Bromisoval Impurity 1
CAS No.	24433-94-1
Molecular Formula	C6H11BrN2O2
Molecular Weight	223.07 g/mol
Synonyms	1-(2-Bromo-3-methylbutanoyl)urea; Bromovalerylurea Impurity A; Bromisoval Related Compound A; α-Bromoisovalerylurea; 2-Bromo-3-methylbutyrylurea; Bromovalerylurea; Bromisoval Impurity A; Bromovalerylurea Impurity 1
EINECS	Contact for details

Quality Control

Every batch of Bromisoval Impurity 1 is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical testing, including HPLC, NMR, and MS, to ensure high purity and accurate identity, meeting the stringent requirements for pharmaceutical reference standards. A comprehensive Certificate of Analysis (COA) detailing purity, identity, and impurity profile is provided with each shipment.

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 in a dry environment to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual 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.