Description

Captopril Related Compound 8 is a high-purity chemical reference standard, specifically identified as a known impurity or degradation product of the antihypertensive drug Captopril. This compound is critical for analytical method development, validation, and quality control processes in pharmaceutical manufacturing and research. It is primarily utilized by pharmaceutical R&D laboratories, quality assurance departments, and contract research organizations (CROs) to ensure the safety, efficacy, and regulatory compliance of Captopril-based drug products.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material for the identification and quantification of specific impurities in Captopril Active Pharmaceutical Ingredient (API) and finished dosage forms.
• Analytical Method Development: Serves as a critical standard for developing and validating HPLC, UPLC, or GC methods to monitor related substances in compliance with ICH Q3A(R2) and Q3B(R2) guidelines.
• Stability Studies: Employed in forced degradation and long-term stability studies to track the formation of degradation products and establish shelf-life specifications.
• Quality Control & Assurance: Essential for in-process testing and release testing of Captopril batches to ensure they meet pharmacopeial standards (USP, EP, BP).
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Research & Development: Used in academic and industrial research to study the metabolism, degradation pathways, and chemical behavior of Captopril.

Basic Information

Product Name	Captopril Related Compound 8
CAS No.	112243-88-6
Molecular Formula	C9H15NO3S
Molecular Weight	217.29 g/mol
Synonyms	1-[(2S)-3-Mercapto-2-methyl-1-oxopropoxy]-L-proline; (2S)-1-[(2S)-3-Mercapto-2-methylpropanoyl]pyrrolidine-2-carboxylic acid; Captopril Disulfide Dimer; Captopril Dimer; Captopril Impurity 8; Captopril Related Substance 8; L-Proline, 1-[(2S)-3-mercapto-2-methyl-1-oxopropoxy]-; Captopril Oxidation Product
EINECS	Contact for details

Quality Control

Our Captopril Related Compound 8 is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including identification by IR and NMR, purity determination by HPLC, and control of specific impurities. A detailed Certificate of Analysis (COA) is provided with each shipment, confirming compliance with in-house specifications aligned with ICH guidelines. We support regulatory requirements for pharmaceutical reference standards.

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 under an inert atmosphere to prevent oxidation and degradation.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to 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.