Description

Alanyl Glutamine Impurity 2 is a high-purity reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of pharmaceutical products containing the dipeptide Alanyl Glutamine. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and research institutions for method development, validation, and impurity profiling in accordance with ICH guidelines.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Alanyl Glutamine Active Pharmaceutical Ingredients (APIs) and finished drug products.
• Analytical Method Development: Essential for developing and validating sensitive HPLC, UPLC, or LC-MS methods to monitor impurity levels during stability studies and batch release.
• Quality Control & Assurance: Serves as a system suitability standard in QC laboratories to ensure the accuracy and precision of impurity testing protocols.
• Regulatory Compliance & Filing: Supports regulatory submissions (e.g., to FDA, EMA) by providing definitive characterization data for specified impurities, as required by ICH Q3A and Q3B.
• Stability Studies: Employed to track the formation and growth of this specific impurity under various stress conditions (heat, light, humidity) to establish product shelf-life.
• Research & Development: Used in pharmacokinetic and metabolic studies to understand the degradation pathways of Alanyl Glutamine.

Basic Information

Item	Details
Product Name	Alanyl Glutamine Impurity 2
CAS No.	1402135-14-1
Molecular Formula	C8H15N3O4
Molecular Weight	217.22 g/mol
Synonyms	L-Alanyl-L-glutamine impurity 2; Alanylglutamine Related Compound 2; (2S)-2-[[(2S)-2-Aminopropanoyl]amino]-5-amino-5-oxopentanoic acid; N-(L-α-Aminopropionyl)-L-glutamine; Alanyl-Glutamine EP Impurity B; Alanyl-Glutamine USP Impurity; Glutamine, N-L-alanyl-; Contact for additional synonyms.
EINECS	Contact for details

Quality Control

Every batch of Alanyl Glutamine Impurity 2 is manufactured and analyzed under strict quality management systems. The product undergoes rigorous identity confirmation, purity analysis, and impurity screening using advanced chromatographic (HPLC, UPLC) and spectroscopic (MS, NMR) techniques to ensure it meets the stringent requirements for a pharmaceutical reference standard. 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) or as indicated on the label or COA. This material is hygroscopic (moisture-sensitive) and must be kept in a dry environment. For long-term storage, consider desiccant use.

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)	Total impurities ≤ 5.0% Any individual unspecified impurity ≤ 1.0%
Water Content (KF)	≤ 5.0% w/w
Residue on Ignition	≤ 0.5%

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