Description

Captopril Impurity F is a designated pharmaceutical reference standard used for the analytical profiling and quality control of the antihypertensive drug Captopril. This compound is critical for ensuring the purity, safety, and efficacy of the final drug product by enabling the accurate identification and quantification of this specific impurity. It is an essential material for pharmaceutical R&D laboratories, quality control units, and regulatory compliance departments engaged in the development and manufacturing of Captopril and its formulations.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for analytical method development and validation.
• Quality Control & Assurance: Used in HPLC, GC, or LC-MS systems for the identification and quantification of Captopril Impurity F in active pharmaceutical ingredients (APIs) and finished dosage forms.
• Regulatory Compliance & Filings: Supports the preparation of regulatory documentation (e.g., for FDA, EMA, ICH) by providing a characterized impurity for stability studies and specification setting.
• Research & Development: Employed in impurity profiling studies to understand the degradation pathways and synthesis by-products of Captopril.
• Pharmacopoeial Testing: Applicable for testing according to pharmacopoeial monographs (e.g., USP, EP, BP) that specify limits for related substances.
• Method Transfer & Verification: Serves as a system suitability test component during the transfer of analytical methods between laboratories or sites.

Basic Information

Product Name	Captopril Impurity F
CAS No.	63250-36-2
Molecular Formula	C9H15NO3S
Molecular Weight	217.29 g/mol
Synonyms	(2S)-1-[(2S)-2-Methyl-3-sulfanylpropanoyl]pyrrolidine-2-carboxylic acid; 1-[(2S)-3-Mercapto-2-methyl-1-oxopropyl]-L-proline; Captopril Disulfide Dimer; Captopril Dimer; L-Proline, 1-[(2S)-3-mercapto-2-methyl-1-oxopropyl]-, (S)-; Captopril Related Compound F; Captopril Impurity D (in some references)
EINECS	Contact for details

Quality Control

Every batch of Captopril Impurity F is manufactured and handled under strict quality management systems. Our products undergo rigorous identity confirmation, purity analysis, and impurity profiling using advanced chromatographic and spectroscopic techniques to ensure compliance with industry standards for reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for purity, assay, and related substances. We support compliance with ICH Q3A/B guidelines and relevant pharmacopoeial 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 in a low-humidity environment to prevent degradation. For long-term storage, consider desiccant use and inert atmosphere sealing.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Assay	97.0% - 102.0% (on anhydrous basis)
Water Content (KF)	≤ 2.0%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm

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