Description

Penicillamine Impurity 1 is a specified impurity of the active pharmaceutical ingredient (API) Penicillamine, used as a critical reference standard in pharmaceutical quality control. This compound is essential for the accurate identification, quantification, and monitoring of impurities during drug development and manufacturing to ensure product safety and efficacy. It is primarily required by pharmaceutical companies, analytical laboratories, and regulatory bodies involved in the synthesis, purification, and quality assurance of Penicillamine-based medications.

Application

• Pharmaceutical Reference Standard: Serves as a certified external standard for calibrating analytical instruments and validating testing methods in QC/QA laboratories.
• Method Development and Validation: Used in the development and validation of chromatographic methods (HPLC, UPLC) for impurity profiling of Penicillamine API.
• Stability Studies: Employed as a marker to track impurity formation and degradation pathways in Penicillamine drug products under various stability conditions.
• Regulatory Compliance and Filing: Critical for preparing regulatory submission documents (e.g., for FDA, EMA) that require detailed impurity identification and control strategies.
• Process Chemistry Research: Used by R&D scientists to study and optimize the Penicillamine synthesis pathway to minimize the formation of this specific impurity.
• Pharmacopoeial Testing: Applied in testing to comply with pharmacopoeial monographs (USP, EP, BP) that set limits for related substances in Penicillamine.

Basic Information

Product Name	Penicillamine Impurity 1
CAS No.	22801-32-7
Molecular Formula	C5H11NO2S
Molecular Weight	149.21 g/mol
Synonyms	D-Penicillamine Disulfide; (R,R)-3,3'-Dithiobis(2-amino-2-methylpropanoic acid); 3,3'-Dithiobis(2-amino-2-methylbutyric acid) isomer; D-Penicillamine dimer; β,β'-Dimethylcysteine disulfide; (2R,2'R)-3,3'-Disulfanediylbis(2-amino-2-methylpropanoic acid); D-3,3'-Dithiobis(2-aminoisovaleric acid); Penicillamine Related Compound A (in some contexts)
EINECS	Contact for details

Quality Control

Every batch of Penicillamine Impurity 1 is manufactured and analyzed under strict quality management systems. The product undergoes rigorous identity confirmation, purity assay, and impurity profiling using advanced analytical techniques to ensure it meets the stringent requirements for use as a pharmaceutical reference standard. A comprehensive Certificate of Analysis (COA) is provided with each batch, detailing results for purity, related substances, and chromatographic data. Our quality commitment aligns with cGMP principles to support our clients' regulatory needs.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C (59-77°F). Keep the container in a dry environment to prevent moisture uptake. For long-term storage, consider storing under inert atmosphere to ensure maximum stability.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual impurity: ≤ 1.0% 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.