Description

Pramipexole Impurity 21 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 dihydrochloride. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling. The availability of this well-characterized impurity standard is essential for maintaining stringent quality control in drug production.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference standard for the identification and quantification of specific impurities in Pramipexole API and finished dosage forms.
• Analytical Method Development & Validation: Serves as a critical component in developing and validating HPLC, UPLC, or GC methods for stability-indicating assays.
• Quality Control & Assurance (QC/QA): Employed in routine batch release testing to monitor impurity levels and ensure compliance with ICH Q3A/B guidelines.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDA).
• Stability Studies: Used to track the formation of degradation products under various stress conditions (e.g., heat, light, humidity).
• Research & Development: Facilitates studies on the synthesis, metabolism, and degradation pathways of pramipexole.

Basic Information

Product Name	Pramipexole Impurity 21
CAS No.	104617-86-9
Molecular Formula	C10H17N3S
Molecular Weight	203.33 g/mol
Synonyms	Pramipexole Related Compound 21; (6S)-6-N-Propyl-4,5,6,7-tetrahydro-1,3-benzothiazole-2,6-diamine; Pramipexole Dihydrochloride Impurity 21; Pramipexole EP Impurity G; Pramipexole USP Related Compound A; SND 919 Impurity; 2-Amino-6-(propylamino)-4,5,6,7-tetrahydro-1,3-benzothiazole
EINECS	Contact for details

Quality Control

Our Pramipexole Impurity 21 is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity, NMR and MS for structural confirmation, and residual solvent analysis. We provide a comprehensive Certificate of Analysis (COA) with each shipment, detailing all test results against established specifications. The material is suitable for use in pharmaceutical applications requiring compliance with ICH, USP, and EP guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, 15-25°C (59-77°F). The container should be kept in a dry environment to prevent moisture uptake. For long-term storage, consider storing under inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0% w/w
Assay (on dried basis)	97.0% - 103.0%

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