Description

Sodium Picosulfate Related Compound A (20 Mg) (4-[(Pyridin-2-Yl)(4-Hydroxyphenyl)Methyl]Phenyl Sodium Sulfate) is a high-purity chemical reference standard, critical for analytical method development and quality control in pharmaceutical manufacturing. This compound serves as a key impurity marker and process-related substance for ensuring the safety and efficacy of the active pharmaceutical ingredient, sodium picosulfate. It is essential for research laboratories, quality assurance departments, and manufacturers engaged in the production and validation of laxative drug formulations.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for HPLC, LC-MS, and other chromatographic methods in pharmacopeial testing (e.g., USP, EP).
• Analytical Method Development: Critical for developing and validating stability-indicating assay methods for sodium picosulfate drug substances and finished products.
• Quality Control & Assurance: Employed in routine batch testing to monitor and control the levels of related substances and degradation products.
• Regulatory Compliance & Filing: Supports regulatory submissions (e.g., FDA, EMA) by providing characterized impurity data for drug master files (DMFs) and new drug applications (NDAs).
• Stability Studies: Acts as a benchmark in forced degradation and long-term stability studies to understand the degradation pathways of sodium picosulfate.
• Research & Development: Utilized in pharmacokinetic and metabolic studies to investigate the behavior of related compounds.

Basic Information

Item	Details
Product Name	Sodium Picosulfate Related Compound A (20 Mg) (4-[(Pyridin-2-Yl)(4-Hydroxyphenyl)Methyl]Phenyl Sodium Sulfate)
CAS No.	32500-19-9
Molecular Formula	C19H16NNaO5S
Molecular Weight	393.39 g/mol
Synonyms	4-[(Pyridin-2-yl)(4-hydroxyphenyl)methyl]phenyl sodium sulfate; Picosulfate Related Substance A; Sodium Picosulfate Impurity A; Sodium 4-[(2-pyridinyl)(4-hydroxyphenyl)methyl]phenyl sulfate; Picosulfate Sodium Related Compound A; Bisacodyl Metabolite Analog; Laxative Drug Impurity Standard
EINECS	Contact for details

Quality Control

Our Sodium Picosulfate Related Compound A is manufactured under strict quality management systems. Each batch is characterized and tested to meet stringent specifications suitable for use as a pharmaceutical reference standard. A comprehensive Certificate of Analysis (COA) is provided, detailing results for identity, purity (by HPLC), and impurity profile. We support compliance with cGMP, ICH Q3A/B guidelines, and major pharmacopeia (USP/EP) requirements for impurities and reference 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 product is hygroscopic (moisture-sensitive); ensure the container is sealed tightly after each use to prevent absorption of atmospheric moisture. For long-term storage, consider desiccants.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 0.5%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.1%

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