Description

Pramipexole Dbta Impurity is a high-purity reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the active pharmaceutical ingredient (API) Pramipexole Dihydrochloride. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling. The material is supplied with comprehensive analytical data to support stringent quality control protocols.

Application

• As a certified reference standard for the quantitative and qualitative analysis of Pramipexole Dihydrochloride API.
• For pharmaceutical research and development, specifically in impurity identification and characterization studies.
• In quality control (QC) laboratories to monitor and control impurity levels during API manufacturing.
• Use in method development and validation for chromatographic techniques like HPLC and UPLC.
• As a critical component in stability studies to understand degradation pathways of Pramipexole formulations.
• For regulatory submissions to agencies such as the FDA and EMA, providing necessary impurity data.

Basic Information

Product Name	Pramipexole Dbta Impurity
CAS No.	1821389-09-6
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Pramipexole Impurity Dbta; Pramipexole Related Compound Dbta; Pramipexole Dihydrochloride Impurity Dbta; (6S)-6-N-Propyl-4,5,6,7-tetrahydro-1,3-benzothiazole-2,6-diamine Impurity; Pramipexole EP Impurity Dbta; Pramipexole USP Impurity; Pramipexole Process Impurity
EINECS	Contact for details

Quality Control

Every batch of our Pramipexole Dbta Impurity is manufactured and analyzed under strict quality management systems. The material undergoes comprehensive testing, including identity confirmation by spectroscopic methods and purity determination by advanced chromatographic techniques, to ensure it meets the exacting standards for pharmaceutical reference materials. A Certificate of Analysis (COA) detailing all test results, including batch-specific HPLC purity, is provided with each shipment to support your regulatory and QC requirements.

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 hygroscopic nature, the container must be kept tightly sealed in a dry environment to prevent moisture absorption, which could affect stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.10% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 1.0%

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