Description

Guaifenesin Ep Impurity C is a high-purity reference standard specifically identified as a process-related impurity of Guaifenesin. This compound is critical for analytical method development and validation, ensuring the quality and safety of the active pharmaceutical ingredient. It is primarily required by pharmaceutical manufacturers and analytical laboratories for rigorous quality control and regulatory compliance testing.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Guaifenesin API and finished dosage forms.
• Analytical Method Development: Essential for developing and validating HPLC, UPLC, or GC methods to monitor process impurities.
• Quality Control & Assurance: Serves as a system suitability standard in routine QC testing to ensure analytical procedures remain accurate and precise.
• Regulatory Compliance & Filing: Supports regulatory submissions (e.g., to FDA, EMA) by providing impurity characterization data required for drug master files (DMFs).
• Stability Studies: Employed to track the formation and level of this specific impurity during forced degradation and long-term stability testing of Guaifenesin.
• Research & Development: Used in pharmaceutical R&D to study impurity profiles, synthesis pathways, and purification processes for Guaifenesin.

Basic Information

Product Name	Guaifenesin Ep Impurity C
CAS No.	1797132-23-0
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Guaifenesin Impurity C, Guaifenesin Related Compound C, EP Impurity C of Guaifenesin, Guaifenesin Process Impurity, 3-(2-Methoxyphenoxy)-1,2-propanediol Impurity C, Guaiphenesin Impurity C
EINECS	Contact for details

Quality Control

Every batch of Guaifenesin Ep Impurity C is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced chromatographic and spectroscopic techniques (e.g., HPLC, GC, NMR, MS) to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment.

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 light-sensitive and should be stored away from light.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Any individual impurity ≤ 1.0%
Total Impurities	≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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