Description

Captopril Disulfide CAS NO 64806-05-9 is a key pharmaceutical intermediate and impurity reference standard, primarily known as the dimeric oxidation product of the antihypertensive drug Captopril. This compound is critical for quality control and analytical research within the pharmaceutical industry, ensuring the purity and stability of the final active pharmaceutical ingredient (API). It is essential for manufacturers, analytical laboratories, and research institutions involved in cardiovascular drug development, production, and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of Captopril-related substances in HPLC and other analytical methods.
• API Manufacturing & Quality Control: A critical marker for monitoring oxidation and ensuring the purity of Captopril API during production and stability studies.
• Research & Development: Employed in metabolic studies, degradation pathway analysis, and formulation research for Captopril-based medications.
• Regulatory Compliance: Supports compliance with pharmacopoeial standards (USP, EP, BP) requiring the control of specified impurities in drug substances and products.
• Analytical Method Development: Serves as a key component in developing and validating stability-indicating assay methods for Captopril.

Basic Information

Item	Detail
Product Name	Captopril Disulfide
CAS No.	64806-05-9
Molecular Formula	C18H28N2O6S2
Molecular Weight	432.56 g/mol
Synonyms	1-[(2S)-3-Mercapto-2-methyl-1-oxopropyl]-L-proline disulfide; Captopril Dimer; Bis(1-[(2S)-3-mercapto-2-methylpropionyl]-L-proline); SQ 14,503 Disulfide; L-Proline, 1-[(2S)-3-mercapto-2-methyl-1-oxopropyl]-, disulfide; Captopril Oxidation Product; Captopril Impurity B (as per some references)
EINECS	Contact for details

Quality Control

Our Captopril Disulfide is produced and tested under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity and identity confirmation (IR, NMR), to ensure it meets the stringent requirements for use as a reference standard. Certificates of Analysis (COA) with detailed chromatographic data are provided to support your regulatory submissions and internal quality protocols.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its sensitivity to oxidation, it is recommended to handle under an inert atmosphere for long-term storage and to minimize headspace in opened containers.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time corresponds to reference
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown 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.