Description

Pramipexole Impurity 27 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 the active pharmaceutical ingredient (API) pramipexole. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and quality control testing.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material for the identification and quantification of specific impurities in pramipexole API and finished drug products.
• Analytical Method Development & Validation: Serves as a critical standard for developing and validating HPLC, UPLC, or GC methods to monitor impurities during manufacturing.
• Quality Control & Assurance (QC/QA): Essential for routine batch release testing in pharmaceutical production to ensure compliance with ICH Q3A/B guidelines.
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Stability Studies: Employed to track the formation of degradation products in pramipexole formulations under various storage conditions.
• Research & Development: Used in pharmacokinetic and metabolic studies to understand the degradation pathways of pramipexole.

Basic Information

Product Name	Pramipexole Impurity 27
CAS No.	1798014-87-5
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Pramipexole Related Compound 27; Pramipexole EP Impurity I; Pramipexole USP Impurity; (S)-N6-Propyl-4,5,6,7-tetrahydro-1,3-benzothiazole-2,6-diamine Impurity; Prami-Peak-27; PXD Imp-27; Pramipexole Degradant; Pramipexole Process Impurity
EINECS	Contact for details

Quality Control

Every batch of Pramipexole Impurity 27 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced chromatographic (HPLC/UPLC) and spectroscopic (NMR, MS) techniques to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results, chromatograms, and traceability information.

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 under inert conditions or in a desiccator to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time matches reference standard
Identification (IR)	Spectrum conforms to reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unknown impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0% w/w

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