Description

Hyoscine Butylbromide Ep Impurity I is a high-purity reference standard critical for pharmaceutical research and development. This compound is essential for the accurate identification, quantification, and control of process-related impurities in the manufacturing of Hyoscine Butylbromide, an important antispasmodic drug. It is primarily required by analytical laboratories, quality control units, and R&D departments within the global pharmaceutical and fine chemical industries to ensure product safety, efficacy, and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for method development, validation, and routine quality control testing of Hyoscine Butylbromide active pharmaceutical ingredient (API) and finished dosage forms.
• Impurity Profiling and Characterization: Used in analytical studies to identify, track, and quantify this specific impurity during API synthesis, helping to optimize manufacturing processes.
• Regulatory Compliance and Documentation: Essential for preparing regulatory submission dossiers (e.g., for FDA, EMA) that require detailed impurity identification and control strategies as per ICH Q3A and Q3B guidelines.
• Stability Studies: Employed as a marker to monitor impurity levels in stability testing of Hyoscine Butylbromide under various storage conditions.
• Method Transfer and Verification: Acts as a key component in the transfer and verification of analytical methods between different laboratories or manufacturing sites.
• Research and Development: Utilized in synthetic chemistry research to study degradation pathways and develop purer synthesis routes for the parent drug compound.

Basic Information

Product Name	Hyoscine Butylbromide Ep Impurity I
CAS No.	2030294-83-6
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Scopolamine Butylbromide Ep Impurity I; Hyoscine Butylbromide Related Compound I; Butylscopolamine Impurity I; Buscopan Impurity I; (1R,2R,4S,5S,7s)-9-Butyl-7-[(2S)-3-hydroxy-2-phenylpropanoyl]oxy-9-methyl-3-oxa-9-azoniatricyclo[3.3.1.0²,⁴]nonane Bromide; N-Butylscopolammonium Bromide Impurity I
EINECS	Contact for details

Quality Control

Every batch of Hyoscine Butylbromide Ep Impurity I is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing, including advanced chromatographic techniques, to ensure compliance with pharmacopeial standards and customer-specific requirements. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing purity, identity, and impurity profile.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic nature, the container must be kept tightly sealed in a dry environment to prevent moisture absorption. For long-term storage, consider desiccants or inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (IR)	Conforms to reference spectrum
Assay (HPLC)	≥ 98.0%
Purity (HPLC, Area %)	≥ 99.0%
Single Unknown Impurity	≤ 0.5%
Total Impurities	≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0%

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