Description

Amino Acid Impurity 25 is a high-purity reference standard critical for analytical method development and validation in pharmaceutical research and manufacturing. This compound is essential for ensuring the accuracy and reliability of impurity profiling and quality control testing for amino acid-based active pharmaceutical ingredients (APIs). It is primarily utilized by analytical chemists, quality assurance professionals, and research scientists in the pharmaceutical and biotechnology sectors. The availability of this well-characterized impurity standard is fundamental for regulatory compliance and maintaining the highest standards of drug safety and efficacy.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the identification and quantification of impurities in amino acid drug substances and finished products.
• Analytical Method Development: Used to develop, optimize, and validate chromatographic methods, such as HPLC and UPLC, for impurity separation and detection.
• Quality Control (QC) Testing: Employed as a system suitability standard and for preparing calibration curves in routine QC testing of APIs to ensure batch-to-batch consistency.
• Stability Studies: Acts as a marker to monitor the formation of specific degradation products in drug substance and drug product stability programs under ICH guidelines.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., FDA, EMA) to establish impurity limits and justify analytical procedures.
• Research & Development: Used in synthetic chemistry research to study reaction pathways and in bioanalytical research for metabolite identification.

Basic Information

Item	Detail
Product Name	Amino Acid Impurity 25
CAS No.	742100-87-4
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	(S)-2-Amino-3-(4-(2-amino-2-oxoethoxy)phenyl)propanoic acid; Amino Acid Related Compound 25; L-Tyrosine, O-(carbamoylmethyl)-; UNII-8P5Q6LUE2F; 742100-87-4; Acetamide, 2-[[(2S)-2-amino-3-(4-hydroxyphenyl)-1-oxopropyl]oxy]-; Impurity of Levofloxacin
EINECS	Contact for details

Quality Control

Every batch of Amino Acid Impurity 25 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity analysis, and impurity profiling using advanced techniques like HPLC, GC, MS, and NMR to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results, analytical methods, and traceability information.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. The product is light-sensitive and should be handled under appropriate conditions to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 5.0% w/w

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