Description

Pramipexole Impurity 49 is a high-purity chemical reference standard used for analytical and quality control purposes in pharmaceutical development and manufacturing. This compound is critical for ensuring the safety, efficacy, and regulatory compliance of the active pharmaceutical ingredient (API) Pramipexole. It is primarily required by pharmaceutical companies, contract research organizations (CROs), and analytical laboratories involved in method development, validation, and impurity profiling. The availability of a well-characterized impurity standard is essential for meeting stringent global regulatory requirements for drug substances.

Application

• Pharmaceutical Impurity Profiling and Identification: Used as a certified reference material (CRM) to identify, quantify, and monitor Pramipexole Impurity 49 during API synthesis and purification processes.
• Analytical Method Development and Validation: Serves as a critical component in developing and validating HPLC, UPLC, or GC methods for the accurate detection of impurities in Pramipexole drug substances and finished products.
• Quality Control and Release Testing: Employed in routine QC laboratories to ensure batch-to-batch consistency and that impurity levels are within International Council for Harmonisation (ICH) guidelines.
• Stability Studies: Used to assess the formation of degradation products in Pramipexole formulations under various stress conditions (e.g., heat, light, humidity) as part of regulatory stability testing.
• Regulatory Submissions: Provides essential data for Drug Master Files (DMFs), Investigational New Drug (IND) applications, and New Drug Applications (NDAs) submitted to agencies like the FDA and EMA.
• Research and Development: Facilitates process chemistry research to understand impurity formation pathways and optimize synthesis routes to minimize its presence.

Basic Information

Product Name	Pramipexole Impurity 49
CAS No.	2165891-88-1
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Pramipexole Related Compound 49; Pramipexole EP Impurity I; Pramipexole USP Impurity; (6S)-6-N-Propyl-4,5,6,7-tetrahydro-1,3-benzothiazole-2,6-diamine impurity; Prami-Peak-49; Pramipexole Degradant; Pramipexole Process Impurity; SND 919 Impurity
EINECS	Contact for details

Quality Control

Every batch of Pramipexole Impurity 49 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing to ensure compliance with industry standards, including ICH Q3A(R2) and Q3B(R2) guidelines for impurities. Comprehensive characterization is performed using advanced analytical techniques. Certificates of Analysis (COA) are provided with each shipment, detailing purity, identity, and impurity profiles.

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 and store in accordance with good laboratory practices.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time matches reference standard
Identification (MS)	Mass spectrum conforms to structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 1.0% Total impurities ≤ 3.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0% w/w

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