Description

Alosetron Impurity 1 CAS NO 1011293-30-3 is a high-purity chemical reference standard used for the analytical profiling and quality control of the pharmaceutical active ingredient, Alosetron. This impurity is critical for ensuring the safety, efficacy, and regulatory compliance of the final drug product. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and batch release testing.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of related substances in Alosetron hydrochloride API and finished dosage forms.
• Analytical Method Development & Validation: Essential for developing and validating stability-indicating HPLC, UPLC, or LC-MS methods to monitor impurity profiles.
• Quality Control & Batch Release: Used in routine QC testing to ensure drug substance and product batches meet stringent pharmacopeial (e.g., USP, EP) and ICH Q3A/B impurity limits.
• Stability Studies: Employed to track the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity) as per ICH guidelines.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., ANDA, NDA) to demonstrate comprehensive impurity characterization and control strategies.
• Research & Development: Utilized in synthetic chemistry R&D to understand and optimize the manufacturing process to minimize impurity formation.

Basic Information

Product Name	Alosetron Impurity 1
CAS No.	1011293-30-3
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Alosetron Related Compound 1; Alosetron Impurity A; Alosetron EP Impurity A; (1S,4S,4aR,9aR)-N,4-Dimethyl-1,2,3,4,4a,9a-hexahydro-1,4-methanobenz[f]isoindol-9-amine; Lotronex Impurity 1
EINECS	Contact for details

Quality Control

Our Alosetron Impurity 1 is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure identity, purity, and traceability. Each batch is supplied with a comprehensive Certificate of Analysis (COA) detailing results from advanced chromatographic and spectroscopic methods. We support compliance with ICH Q3A, Q3B, USP, and EP guidelines for impurities in new drug substances and products.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or Certificate of Analysis. The material should be kept in a dry environment and handled under appropriate laboratory conditions to maintain stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unspecified impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C

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