Description

Alanyl Glutamine Impurity 7 is a high-purity chemical reference standard used for analytical and quality control purposes. This compound is critical for pharmaceutical manufacturers and research laboratories to ensure the purity, safety, and efficacy of the active pharmaceutical ingredient (API) Alanyl Glutamine. It is primarily utilized by professionals in pharmaceutical development, quality assurance (QA), and regulatory affairs for method validation, impurity profiling, and compliance testing.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the quantitative and qualitative analysis of Alanyl Glutamine API.
• Method Development and Validation (HPLC/LC-MS): Used to develop, optimize, and validate chromatographic methods for impurity detection and separation.
• Quality Control and Batch Release: Essential for routine QC testing to monitor and control impurity levels in commercial drug substance batches, ensuring compliance with ICH guidelines.
• Stability Studies: Employed to identify and quantify degradation products that may form under various stress conditions during drug product shelf-life studies.
• Regulatory Submissions: Provides necessary impurity characterization data for Drug Master Files (DMFs), Investigational New Drug (IND), and New Drug Application (NDA) filings.
• Research and Development: Used in synthetic chemistry R&D to understand impurity formation pathways and to develop robust purification processes.

Basic Information

Item	Detail
Product Name	Alanyl Glutamine Impurity 7
CAS No.	1508274-80-3
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	L-Alanyl-L-glutamine Impurity 7; Alanyl-Glutamine Related Compound 7; N-(2-[(2S)-2-[[(2S)-2-Aminopropanoyl]amino]-4-carboxybutanoyl]amino)ethyl)-L-glutamine; Impurity 7 of Alanyl Glutamine; Dipeptide impurity standard; GLN-ALA Impurity 7; (S)-2-((S)-2-Acetamidopropanamido)-5-amino-5-oxopentanoic acid (possible isomer/structure variant)
EINECS	Contact for details

Quality Control

Every batch of Alanyl Glutamine Impurity 7 is manufactured and analyzed under strict quality management systems. The product is characterized using advanced analytical techniques including HPLC, LC-MS, and NMR to confirm identity and purity. A comprehensive Certificate of Analysis (COA) is provided with each lot, detailing all test results against stringent in-house specifications. Our quality commitment aligns with cGMP principles and ICH Q3A/B guidelines for impurities in new drug substances and products.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept under anhydrous conditions. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (MS)	Mass spectrum conforms to structure
Purity (HPLC)	≥ 95.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C

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