Description

Tamsulosin Ep Impurity CAS NO 1798904-07-0 is a high-purity chemical reference standard used in the pharmaceutical development and quality control of Tamsulosin hydrochloride, an α-1 adrenergic receptor antagonist. This impurity is critical for ensuring the safety, efficacy, and regulatory compliance of the final drug product by enabling accurate identification and quantification of related substances. It is an essential material for analytical chemists and quality assurance professionals in pharmaceutical R&D and manufacturing, particularly for method validation and stability studies.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for the identification and quantification of impurities in Tamsulosin hydrochloride Active Pharmaceutical Ingredient (API) and finished dosage forms.
• Analytical Method Development & Validation: Critical for developing and validating sensitive and specific HPLC, UPLC, or LC-MS methods to monitor impurity profiles.
• Quality Control & Batch Release Testing: Used in routine QC laboratories to ensure API and drug products meet stringent pharmacopeial (e.g., USP, EP, ICH) specifications for related substances.
• Stability Studies & Forced Degradation: Employed to identify and track degradation products formed under various stress conditions (e.g., heat, light, humidity) to establish product shelf-life.
• Regulatory Submissions: Provides essential data for Drug Master Files (DMFs), Common Technical Documents (CTDs), and other regulatory filings to demonstrate comprehensive impurity control.
• Process Chemistry Research: Aids in understanding and optimizing the synthetic pathway for Tamsulosin to minimize the formation of this specific impurity.

Basic Information

Item	Detail
Product Name	Tamsulosin Ep Impurity
CAS No.	1798904-07-0
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Tamsulosin Impurity; Tamsulosin Related Compound; Tamsulosin EP Impurity; Tamsulosin Hydrochloride Impurity; (R)-5-[2-[[2-(2-Ethoxyphenoxy)ethyl]amino]propyl]-2-methoxybenzenesulfonamide; Tamsulosin Sulfonamide Epimer; Tamsulosin Stereoisomer Impurity
EINECS	Contact for details

Quality Control

Every batch of Tamsulosin Ep Impurity is manufactured and analyzed under strict quality management systems. The product undergoes comprehensive testing, including identity confirmation by spectroscopic methods (IR, NMR, MS) and purity assessment by advanced chromatographic techniques (HPLC, UPLC) to ensure it meets the high standards required for pharmaceutical reference materials. A detailed Certificate of Analysis (COA) is provided with each shipment, documenting batch-specific results and confirming compliance with relevant guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This compound is hygroscopic (moisture-sensitive); therefore, the container must be kept tightly sealed in a dry environment to prevent absorption of moisture. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unknown impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 5.0%

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