Description

Captopril Ep Impurity B CAS NO 112243-90-0 is a specified impurity used in the quality control and analytical profiling of the active pharmaceutical ingredient (API) Captopril. This compound is critical for ensuring the purity, safety, and efficacy of Captopril formulations by serving as a reference standard in chromatographic analysis. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and routine batch release testing.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Captopril-related impurities in compliance with pharmacopeial monographs (e.g., USP, EP, BP).
• Analytical Method Development: Essential for developing and validating stability-indicating HPLC or UPLC methods to monitor impurity profiles in Captopril API and finished dosage forms.
• Quality Control & Batch Release: Employed in routine QC testing to ensure Captopril batches meet stringent regulatory specifications for impurity limits.
• Stability Studies: Used as a marker to assess the degradation pathways and shelf-life of Captopril under various stress conditions (thermal, photolytic, hydrolytic).
• Regulatory Submissions: Supports the filing of regulatory documents (e.g., DMF, CMC sections) by providing impurity characterization data.
• Research & Development: Facilitates research into the synthesis, metabolism, and degradation chemistry of Captopril and its analogs.

Basic Information

Product Name	Captopril Ep Impurity B
CAS No.	112243-90-0
Molecular Formula	C9H15NO3S
Molecular Weight	217.29 g/mol
Synonyms	Captopril Disulfide; (2S)-1-[(2S)-2-Methyl-3-sulfanylpropanoyl]pyrrolidine-2-carboxylic acid; L-Captopril Disulfide; 1-[(2S)-3-Mercapto-2-methyl-1-oxopropyl]-L-proline Disulfide; SQ 14,554 Disulfide; Captopril Dimer; Captopril EP Impurity B; Captopril Related Compound B
EINECS	Contact for details

Quality Control

Every batch of Captopril Ep Impurity B is manufactured and analyzed under strict quality management systems. The product undergoes rigorous identity, purity, and assay testing using validated analytical methods such as HPLC, NMR, and mass spectrometry to ensure it meets the high-purity standards required for use as a reference material. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results and confirming compliance with relevant pharmacopeial guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single impurity ≤ 1.0%
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.