Description

Alanyl Glutamine Impurity 5 is a high-purity chemical reference standard used for analytical and quality control purposes. This compound is critical for ensuring the purity, safety, and efficacy of pharmaceutical products containing the dipeptide Alanyl Glutamine. It is primarily utilized by research institutions, analytical laboratories, and pharmaceutical manufacturers engaged in method development, validation, and regulatory compliance testing for peptide-based therapeutics and parenteral nutrition solutions.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of related substances in Alanyl Glutamine Active Pharmaceutical Ingredients (APIs) and finished drug products.
• Analytical Method Development & Validation (HPLC/LC-MS): Essential for developing and validating chromatographic methods to monitor impurities and ensure product quality.
• Quality Control & Assurance (QC/QA): Serves as a critical tool in routine quality control testing to confirm the impurity profile meets pharmacopeial specifications (e.g., USP, EP, ICH guidelines).
• Stability Studies: Employed to track the formation of degradation products in Alanyl Glutamine formulations under various stress conditions.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., FDA, EMA) by providing definitive proof of impurity characterization and control strategies.
• Research on Peptide Degradation Pathways: Used in academic and industrial research to study the stability and degradation mechanisms of the Alanyl Glutamine dipeptide.

Basic Information

Product Name	Alanyl Glutamine Impurity 5
CAS No.	3929-63-3
Molecular Formula	C8H15N3O4
Molecular Weight	217.22 g/mol
Synonyms	L-Alanyl-L-glutamine impurity 5; Alanylglutamine Related Compound; (2S)-2-[[(2S)-2-Aminopropanoyl]amino]-5-amino-5-oxopentanoic acid; L-α-Glutamine, N-L-alanyl-; N2-L-Alanyl-L-glutamine impurity; Ala-Gln Impurity 5; Peptide impurity standard; Dipeptide derivative impurity
EINECS	Contact for details

Quality Control

Every batch of Alanyl Glutamine Impurity 5 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 and mass spectrometry to ensure they meet the exacting standards required for reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results and confirming compliance with relevant guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. For long-term storage, consider storing at 2-8°C. Keep the container sealed to protect from moisture.

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%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.5%

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