Description

Picosulfate Impurity 9 is a specified impurity and reference standard used in the analytical profiling of Sodium Picosulfate, a stimulant laxative 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 for method development, validation, and batch release testing.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of related substances in Sodium Picosulfate API and finished drug products.
• Analytical Method Development & Validation: Essential for developing and validating stability-indicating HPLC, UPLC, or LC-MS methods in compliance with ICH guidelines.
• Quality Control & Batch Release: Serves as a system suitability and calibration standard in routine QC testing to ensure API and drug product purity meets pharmacopeial specifications (e.g., USP, EP, JP).
• Stability Studies: Employed to monitor the formation of degradation products in Sodium Picosulfate under various stress conditions (heat, light, humidity).
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., ANDA, NDA, MAA) to demonstrate control strategy over potential impurities.
• Research & Development: Used in R&D to understand the degradation pathways and impurity profile of Sodium Picosulfate during synthesis and formulation processes.

Basic Information

Product Name	Picosulfate Impurity 9
CAS No.	22945-62-6
Molecular Formula	C18H19NO8S
Molecular Weight	409.41 g/mol
Synonyms	4,4'-(2-Pyridylmethylene)diphenol bis(hydrogen sulfate) ester; Picosulfate Related Compound; Sodium Picosulfate Impurity 9; Picosulfate EP Impurity B; Picosulfate USP Impurity; Bis(4-sulfophenyl)-(2-pyridyl)methanol ester; Picosulfate Degradant
EINECS	Contact for details

Quality Control

Every batch of Picosulfate Impurity 9 is manufactured and analyzed under strict quality management systems. The material is characterized using advanced spectroscopic and chromatographic techniques (HPLC, LC-MS, NMR) to confirm identity and purity. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for purity, assay, and related substances. Our quality standards align with the requirements for pharmaceutical reference standards.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. The material is hygroscopic (moisture-sensitive); ensure the container is sealed after each use to prevent absorption of moisture.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Assay (HPLC)	90.0% - 110.0% (on anhydrous basis)
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.5%
Heavy Metals	≤ 20 ppm

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