Description

Imp. K (Ep) is a high-purity pharmaceutical intermediate and reference standard, identified by CAS No. 40610-41-1. It is a critical component in the synthesis and quality control of active pharmaceutical ingredients (APIs), ensuring batch-to-batch consistency and regulatory compliance. This compound is essential for manufacturers and quality control laboratories in the pharmaceutical and fine chemical industries.

Application

• Pharmaceutical Intermediate: A key building block in the synthesis of complex drug molecules.
• Pharmacopoeial Reference Standard: Used as an impurity standard (Imp. K) for method validation and quality testing per European Pharmacopoeia (EP) monographs.
• Analytical Research: Serves as a certified reference material (CRM) in HPLC, LC-MS, and other chromatographic analyses for accurate quantification.
• Process Development & Validation: Employed in scaling up API manufacturing processes and establishing impurity profiles.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., CMC sections) by providing a qualified impurity standard for stability and release testing.

Basic Information

Product Name	Imp. K (Ep)
CAS No.	40610-41-1
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	European Pharmacopoeia Impurity K; EP Impurity K; API Impurity K; Pharmaceutical Impurity Standard K; CAS 40610-41-1; (Specific IUPAC name to be confirmed); Impurity K Reference Standard
EINECS	Contact for details

Quality Control

Our Imp. K (Ep) is produced and handled under strict quality management systems. Each batch is subjected to comprehensive analytical testing, including chromatographic purity and identity confirmation, to ensure it meets the stringent requirements for pharmacopoeial reference standards. A detailed Certificate of Analysis (COA) is provided with every shipment, documenting compliance with relevant specifications.

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 dry environment to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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