Description

Captopril Impurity H is a designated impurity of the active pharmaceutical ingredient Captopril, an angiotensin-converting enzyme (ACE) inhibitor. This compound is critical for pharmaceutical research and development, serving as a key reference standard for analytical method development, validation, and quality control processes. It is primarily utilized by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies to ensure the purity, safety, and efficacy of Captopril-based drug products.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Captopril drug substances and finished products.
• Analytical Method Development: Essential for developing and validating chromatographic methods, such as HPLC and UPLC, to monitor impurity profiles.
• Quality Control & Assurance (QC/QA): A critical component in routine batch release testing to ensure compliance with pharmacopeial limits (e.g., USP, EP, ICH Q3A/B).
• Stability Studies: Employed to track the formation of degradation products under various stress conditions to establish product shelf-life.
• Regulatory Submissions: Provides necessary impurity characterization data for drug master files (DMFs), investigational new drug (IND), and new drug application (NDA) submissions.
• Research & Development: Used in synthetic chemistry research to study degradation pathways and to synthesize purer batches of the active ingredient.

Basic Information

Product Name	Captopril Impurity H
CAS No.	205521-07-9
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; SQ-14,554 Disulfide; Acepril Impurity H; Capoten Impurity H
EINECS	Contact for details

Quality Control

Our Captopril Impurity H is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including identification by spectroscopic methods (IR, NMR), purity assessment by HPLC, and determination of residual solvents. We provide Certificates of Analysis (COA) with detailed chromatograms and batch-specific data to support your regulatory and quality requirements. The material is suitable for use as a reference standard in compliance with ICH 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 product is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccants or inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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