Description

Primaquine Impurity 7 is a designated impurity standard used in the analytical profiling and quality control of the antimalarial drug Primaquine. This compound is critical for pharmaceutical manufacturers and research laboratories to ensure drug purity, safety, and regulatory compliance. It serves as a key reference material for method development, validation, and stability studies in the pharmaceutical industry.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of Primaquine Impurity 7 in Primaquine active pharmaceutical ingredient (API) and finished drug products.
• Analytical Method Development: Essential for developing and validating HPLC, UPLC, or GC methods to monitor impurities during drug manufacturing.
• Quality Control & Assurance (QC/QA): Provides a benchmark for routine quality control testing to ensure Primaquine batches meet pharmacopeial specifications (e.g., USP, EP).
• Stability Studies: Employed in forced degradation and long-term stability studies to track the formation of this specific impurity over time and under various conditions.
• Regulatory Compliance & Filings: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing characterized impurity data for drug master files (DMFs) and investigational new drug (IND) applications.
• Research & Development: Used in synthetic chemistry research to study the degradation pathways of Primaquine and to develop improved synthetic processes with lower impurity profiles.

Basic Information

Item	Details
Product Name	Primaquine Impurity 7
CAS No.	77229-69-7
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Primaquine Related Compound 7; Primaquine EP Impurity 7; Primaquine USP Impurity 7; 6-Methoxy-8-[(4-amino-1-methylbutyl)amino]-4-methylquinoline impurity; 1,4-Pentanediamine, N1-(6-methoxy-4-methyl-8-quinolinyl)-, (S)-; (S)-N1-(6-Methoxy-4-methylquinolin-8-yl)pentane-1,4-diamine
EINECS	Contact for details

Quality Control

Every batch of Primaquine Impurity 7 is manufactured and analyzed under strict quality management systems. The product undergoes rigorous testing, including chromatographic purity analysis and spectroscopic identification, to ensure it meets the high standards required for pharmaceutical impurity standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for identity, purity, and assay.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity. Handle and store under inert atmosphere if specified.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 95.0%
Assay	≥ 98.0%
Water Content	≤ 2.0%
Residual Solvents	Complies with ICH guidelines

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