Description

Pramipexole Impurity 30 is a designated reference standard used in the analytical profiling and quality control of the active pharmaceutical ingredient (API) Pramipexole. This compound is critical for ensuring the purity, safety, and efficacy of Pramipexole-based drug products by serving as a benchmark for identification and quantification during method development and validation. It is an essential material for pharmaceutical manufacturers, analytical laboratories, and regulatory bodies focused on compliance with stringent pharmacopeial standards such as USP and ICH guidelines.

Application

• Pharmaceutical Impurity Profiling: Primary use as a certified reference standard for the identification and quantification of specific impurities in Pramipexole API and finished dosage forms.
• Analytical Method Development & Validation: A critical component for developing, optimizing, and validating stability-indicating HPLC, UPLC, or LC-MS methods according to ICH Q2(R1) guidelines.
• Quality Control & Batch Release: Used in routine QC testing to monitor impurity levels and ensure every batch of Pramipexole meets predefined specification limits.
• Stability Studies: Employed to track the formation of this specific impurity under various stress conditions (e.g., heat, light, humidity) as part of forced degradation and shelf-life studies.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., ANDA, NDA) to demonstrate comprehensive impurity control strategies to agencies like the FDA and EMA.
• Research & Development: Supports synthetic route optimization and process chemistry research by helping to identify and control process-related impurities.

Basic Information

Product Name	Pramipexole Impurity 30
CAS No.	1802051-36-0
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Pramipexole Related Compound 30; Pramipexole EP Impurity I; Pramipexole USP Impurity; Pramipexole Process Impurity; (S)-N6-Propyl-4,5,6,7-tetrahydro-1,3-benzothiazole-2,6-diamine Impurity; SND 919 Impurity; Mirapex Impurity
EINECS	Contact for details

Quality Control

Every batch of Pramipexole Impurity 30 is manufactured and analyzed 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 pharmacopeial standards. 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, Q3B, and Q6A guidelines for impurities in new drug substances and products.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C (59-77°F). For long-term storage, consider storing desiccated at 2-8°C. Handle the material under an inert atmosphere if specified to prevent degradation.

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 (HPLC)	98.0% - 102.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0%

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