Description

Pramipexole Impurity 11 is a high-purity reference standard used for analytical and research purposes. This compound is critical for pharmaceutical quality control, enabling the accurate identification and quantification of a specific impurity in Pramipexole drug substances and products. It is an essential material for analytical chemists and quality assurance professionals in the pharmaceutical industry, particularly those involved in method development, validation, and regulatory compliance. The availability of a well-characterized impurity standard is fundamental to ensuring drug safety and efficacy.

Application

• Pharmaceutical Impurity Profiling and Characterization: Serves as a certified reference material for identifying and quantifying Pramipexole Impurity 11 in active pharmaceutical ingredients (APIs) and finished dosage forms.
• Analytical Method Development and Validation: Used as a critical component in developing, optimizing, and validating HPLC, UPLC, or LC-MS methods for impurity analysis.
• Stability Studies and Forced Degradation Testing: Employed as a marker to monitor the formation of this specific impurity under various stress conditions (e.g., heat, light, humidity).
• Regulatory Compliance and Submission: Provides essential data for regulatory filings (e.g., ANDA, NDA) to meet ICH Q3A(R2) and Q3B(R2) guidelines on impurities in new drug substances and products.
• Quality Control (QC) Testing: Used as a system suitability standard and for routine batch release testing in pharmaceutical manufacturing QC laboratories.
• Research and Development: Supports synthetic chemistry research aimed at understanding impurity formation pathways and developing purer synthetic routes for Pramipexole.

Basic Information

Product Name	Pramipexole Impurity 11
CAS No.	1585235-18-2
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Pramipexole Related Compound 11; Pramipexole EP Impurity J; Pramipexole USP Impurity; (6S)-6-N-Propyl-4,5,6,7-tetrahydro-1,3-benzothiazole-2,6-diamine impurity; Pramipecole Impurity 11; Pramipexole Dihydrochloride Impurity 11; SND 919 Impurity
EINECS	Contact for details

Quality Control

Every batch of Pramipexole Impurity 11 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced analytical techniques such as HPLC, GC, NMR, and MS to ensure compliance with industry and pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results. We support compliance with ICH, USP, and EP guidelines for impurity standards.

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); the container must be kept tightly sealed in a dry environment to prevent absorption of water vapor. For long-term storage, consider storing under an inert atmosphere.

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%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0%

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