Description

Engleet Net Impurity 07 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of pharmaceutical products and advanced materials. It is primarily utilized by researchers and quality control professionals in the pharmaceutical, biotechnology, and fine chemical industries for method development, validation, and impurity profiling.

Application

• Pharmaceutical Impurity Reference Standard: Used as a certified reference material for the identification and quantification of impurities in Active Pharmaceutical Ingredients (APIs) and finished drug products.
• Analytical Method Development & Validation: Serves as a critical component in developing and validating HPLC, UPLC, GC, or LC-MS methods for purity analysis.
• Quality Control & Assurance: Employed in routine QC testing to monitor batch-to-batch consistency and ensure product specifications are met.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., for FDA, EMA) by providing characterized impurity data for drug master files.
• Research & Development: Used in synthetic chemistry and process research to study degradation pathways and stability profiles of new chemical entities.
• Calibration Standard: Acts as a precise calibration standard for analytical instrumentation to ensure accurate and reliable measurements.

Basic Information

Item	Detail
Product Name	Engleet Net Impurity 07
CAS No.	1620758-33-9
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Net Impurity 07; ENGLEET-NET-IMP-07; 1620758-33-9; (S)-2-((S)-2-Acetamido-3-phenylpropanamido)-N-(4-fluorobenzyl)-3-methylbutanamide (example IUPAC - contact for confirmation); Pharmaceutical Impurity 07; Analytical Reference Standard 07; Process Related Impurity 07
EINECS	Contact for details

Quality Control

Every batch of Engleet Net Impurity 07 is manufactured under controlled conditions and undergoes rigorous analytical testing to ensure identity, purity, and consistency. Our quality system is designed to meet the stringent requirements of research and pharmaceutical reference standards. A comprehensive Certificate of Analysis (COA) detailing purity, assay, and impurity profile is provided with each shipment and is available upon request.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (typically 15-25°C). Keep the container tightly sealed in a dry environment to maintain stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH guidelines
Water Content (KF)	≤ 0.5%

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