Description

Penicillamine Impurity 3 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of Penicillamine, a key active pharmaceutical ingredient. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling. The reliable identification and quantification of this impurity are essential for maintaining stringent pharmacopeial standards in drug production.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the quality control and release testing of Penicillamine API and finished dosage forms.
• Analytical Method Development: Used in HPLC, UPLC, and GC method development and validation to establish specificity, accuracy, and detection limits for impurity analysis.
• Stability Studies: Employed as a marker compound in forced degradation and long-term stability studies to monitor impurity formation in Penicillamine formulations.
• Regulatory Compliance & Filings: Essential for preparing regulatory documentation (e.g., for FDA, EMA) to demonstrate comprehensive impurity control strategies.
• Research & Development: Utilized in pharmaceutical R&D to study the degradation pathways, metabolism, and pharmacokinetics of Penicillamine.
• Quality Assurance/Control (QA/QC): Acts as a system suitability and identification standard in routine QC testing to ensure batch-to-batch consistency and purity.

Basic Information

Product Name	Penicillamine Impurity 3
CAS No.	856846-79-2
Molecular Formula	C5H11NO2S
Molecular Weight	149.21 g/mol
Synonyms	D-Penicillamine Disulfide; (2R)-2-Amino-3-methyl-3-[(2R)-2-amino-2-carboxyethyl]dithiobutanoic Acid; (R,R)-Penicillamine Disulfide; L-Penicillamine Disulfide Impurity; Penicillamine Dimer; 3,3'-Dithiobis(2-amino-3-methylbutanoic acid) (stereoisomer); Penicillamine Related Compound C
EINECS	Contact for details

Quality Control

Every batch of Penicillamine Impurity 3 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced techniques like HPLC and NMR to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results. We support compliance with ICH Q3A/B guidelines and can supply materials suitable for use in GMP-regulated environments.

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 must be kept in a desiccated environment to maintain stability and purity. For long-term storage, consider storing under an inert atmosphere.

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)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
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.