Description

Pramipexole Impurity 16 is a designated pharmaceutical reference standard used for analytical and quality control purposes. This compound is critical for ensuring the purity, safety, and efficacy of the active pharmaceutical ingredient (API) Pramipexole, a medication used to treat Parkinson's disease and restless legs syndrome. It is an essential tool for pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in research, development, and quality assurance processes. The precise characterization of this impurity is fundamental for meeting stringent pharmacopeial standards and regulatory compliance.

Application

• Pharmaceutical Impurity Profiling and Identification in Pramipexole API and finished dosage forms.
• Analytical Method Development and Validation for HPLC, UPLC, and LC-MS techniques.
• Quality Control and Batch Release Testing to ensure API purity meets pharmacopeial (USP, EP) specifications.
• Stability Studies to monitor impurity levels in drug products over time under various storage conditions.
• Regulatory Submissions and Compliance, providing necessary data for FDA, EMA, and other global health authority filings.
• Research and Development of Pramipexole synthesis pathways and degradation studies.
• Calibration Standard for quantitative analysis in certified testing laboratories.

Basic Information

Product Name	Pramipexole Impurity 16
CAS No.	104632-27-1
Molecular Formula	C10H17N3S
Molecular Weight	203.33 g/mol
Synonyms	Pramipexole Related Compound; 2-Amino-4,5,6,7-tetrahydro-6-(propylamino)benzothiazole; (6R)-6-N-Propyl-4,5,6,7-tetrahydro-1,3-benzothiazole-2,6-diamine; Pramipexole EP Impurity B; Pramipexole USP Related Compound; SND 919 Impurity
EINECS	Contact for details

Quality Control

Every batch of Pramipexole Impurity 16 is manufactured and controlled under a strict quality management system. The product undergoes comprehensive analytical testing, including HPLC purity, identity confirmation (IR, MS), and residual solvent analysis, to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing all test results and confirming compliance with specified criteria. Our quality protocols are designed to support regulatory requirements for drug master files (DMFs) and investigational new drug (IND) applications.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15°C and 25°C (59°F and 77°F), in a dry environment. For long-term storage, consider storing desiccated at 2-8°C. Handle the material under appropriate laboratory conditions to prevent contamination.

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%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 0.5% w/w

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