Description

Alanyl Glutamine Impurity 8 Hcl is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for the quality control and regulatory compliance of pharmaceutical products containing the dipeptide Alanyl Glutamine. It is primarily utilized by analytical chemists and quality assurance professionals in the pharmaceutical and biotechnology industries for method development, validation, and impurity profiling.

Application

• Pharmaceutical Impurity Profiling and Identification: Serves as a certified reference material (CRM) for the identification and quantification of a specific impurity in Alanyl Glutamine active pharmaceutical ingredient (API) and finished drug products.
• Analytical Method Development and Validation: Used as a critical standard to develop, optimize, and validate chromatographic methods, such as HPLC and UPLC, ensuring accurate impurity detection limits.
• Stability Studies and Forced Degradation Testing: Employed in studies to understand the degradation pathways of Alanyl Glutamine and to qualify related substances formed under stress conditions.
• Quality Control and Batch Release Testing: Essential for routine QC testing of Alanyl Glutamine API to ensure batches meet stringent pharmacopeial (e.g., USP, EP) specifications for impurity limits.
• Regulatory Documentation and Submission: Provides necessary data for regulatory filings (e.g., FDA, EMA) to establish impurity thresholds and justify specifications.
• Research and Development: Supports R&D efforts in peptide chemistry, studying impurity formation mechanisms and synthesis pathway optimization.

Basic Information

Item	Detail
Product Name	Alanyl Glutamine Impurity 8 Hcl
CAS No.	97998-65-7
Molecular Formula	C8H15N3O4 • HCl
Molecular Weight	253.68 g/mol
Synonyms	L-Alanyl-L-glutamine impurity 8 hydrochloride; N-(2S)-2-Aminopropanoyl-L-glutamine hydrochloride; Alanylglutamine Related Compound 8 HCl; L-Alanyl-L-glutamine HCl impurity 8; Alanyl-Glutamine Impurity 8 (Hydrochloride Salt); 97998-65-7; (S)-2-Amino-N-((S)-1-amino-1-oxopentan-3-yl)propanamide hydrochloride
EINECS	Contact for details

Quality Control

Every batch of Alanyl Glutamine Impurity 8 Hcl is manufactured and analyzed under strict quality management systems. The product undergoes rigorous identity confirmation, purity assay, and impurity profile testing using advanced analytical techniques including HPLC, MS, and NMR to ensure it meets the high standards required for reference materials. 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 in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept in a desiccated environment to prevent degradation. For long-term storage, consider conditions of 2-8°C.

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%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.5%
Heavy Metals	≤ 20 ppm
Specific Optical Rotation	Contact for details

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