Description

Picosulfate Impurity 5 is a specified impurity and reference standard used in the analytical profiling of Sodium Picosulfate, an active pharmaceutical ingredient (API). This compound is critical for ensuring the purity, safety, and efficacy of pharmaceutical formulations through rigorous quality control protocols. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in the development and quality assurance of laxative medications. The precise characterization of this impurity is essential for meeting stringent pharmacopeial standards and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Sodium Picosulfate API and finished drug products.
• Analytical Method Development & Validation: Essential for developing, calibrating, and validating High-Performance Liquid Chromatography (HPLC) and other chromatographic methods.
• Quality Control & Assurance (QC/QA): Employed in routine batch testing to monitor impurity levels and ensure compliance with ICH guidelines and pharmacopeial monographs (e.g., USP, EP).
• Stability Studies: Used to track the formation of degradation products in Sodium Picosulfate under various stress conditions.
• Regulatory Submissions: Provides necessary data for Drug Master Files (DMFs), Investigational New Drug (IND), and New Drug Application (NDA) submissions to agencies like the FDA and EMA.
• Research & Development: Supports impurity profiling and route scouting during the synthetic process development of Sodium Picosulfate.

Basic Information

Item	Detail
Product Name	Picosulfate Impurity 5
CAS No.	158839-52-2
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	4,4'-(2-Pyridylmethylene)diphenol bis(hydrogen sulfate) (ester); Sodium Picosulfate Related Compound; Picosulfate Related Substance 5; Picosulfate Impurity C; Picosulfate EP Impurity C; Picosulfate USP Impurity; 4,4'-(Pyridin-2-ylmethylene)diphenyl disulfate
EINECS	Contact for details

Quality Control

Every batch of Picosulfate Impurity 5 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous testing to ensure identity, purity, and consistency, aligning with current ICH Q3A/B guidelines for impurities. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results from advanced analytical techniques. We support compliance with major pharmacopeial standards, including USP and EP.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C (59-77°F), in a dry environment. The product is light-sensitive and should be handled under appropriate conditions to maintain stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
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.