Description

Spasmolytol Gc Standard is a high-purity reference standard material, identified by CAS No. 25333-96-4, essential for precise analytical and quality control workflows. This compound serves as a critical benchmark for ensuring the accuracy, consistency, and regulatory compliance of analytical methods. It is primarily utilized by quality assurance laboratories, research institutions, and production facilities within the pharmaceutical, nutraceutical, and fine chemical sectors that require validated reference materials for their processes.

Application

• Pharmaceutical Quality Control: Primary use as a certified reference standard for the identification and quantitative assay of Spasmolytol in active pharmaceutical ingredients (APIs) and finished dosage forms via chromatographic methods like HPLC and GC.
• Method Development and Validation: Serves as a critical component in developing, calibrating, and validating new analytical procedures to meet ICH, USP, and EP guidelines.
• Regulatory Compliance and Documentation: Provides the traceable standard necessary for generating regulatory submission data for agencies such as the FDA, EMA, and other global health authorities.
• Research and Development: Used in pharmacological and metabolic studies as a pure substance to understand the compound's properties, stability, and behavior.
• Laboratory Proficiency Testing: Acts as a known standard in inter-laboratory comparison studies to ensure consistency and accuracy across different testing sites.

Basic Information

Product Name	Spasmolytol Gc Standard
CAS No.	25333-96-4
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Spasmolytol; Spasmolytol Reference Standard; CAS 25333-96-4; Spasmolytol (GC Standard); Spasmolytol Analytical Standard; Spasmolytol for system suitability
EINECS	Contact for details

Quality Control

Every batch of Spasmolytol Gc Standard is manufactured and handled under strict quality management systems. The material undergoes comprehensive analytical testing to confirm its identity, purity, and suitability for use as a reference standard. A detailed Certificate of Analysis (COA), providing batch-specific data from tests such as HPLC assay and related substances, is supplied with each unit to ensure full traceability and compliance with industry requirements.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed in a dry environment to prevent absorption of moisture, which could compromise the standard's integrity and certified value.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Assay (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single impurity ≤ 1.0%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.1%

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