Description

Alanyl Glutamine Impurity 19 is a high-purity reference standard used for analytical and quality control purposes in pharmaceutical development. This compound is critical for ensuring the purity, safety, and efficacy of the active pharmaceutical ingredient (API) Alanyl Glutamine. It is primarily utilized by research institutions, analytical laboratories, and pharmaceutical manufacturers involved in method validation, stability studies, and regulatory compliance testing.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the qualitative and quantitative analysis of Alanyl Glutamine API.
• Method Development and Validation (HPLC/LC-MS): Used to develop, optimize, and validate chromatographic methods for impurity profiling.
• Quality Control and Batch Release: Essential for routine QC testing to monitor and control impurity levels in commercial API batches, ensuring they meet pharmacopeial specifications.
• Stability Studies: Employed to identify and quantify degradation products that may form under various stress conditions (e.g., heat, light, humidity).
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Research and Development: Used in synthetic route optimization and process chemistry to understand and minimize impurity formation.

Basic Information

Product Name	Alanyl Glutamine Impurity 19
CAS No.	672284-92-3
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	L-Alanyl-L-glutamine impurity 19; Alanyl-Glutamine Related Compound 19; Dipeptide impurity; (2S)-2-[[(2S)-2-Aminopropanoyl]amino]-5-amino-5-oxopentanoic acid (IUPAC); Glutamine-Alanine impurity; Ala-Gln Impurity 19; Pharmaceutical impurity standard; Analytical reference standard
EINECS	Contact for details

Quality Control

Every batch of Alanyl Glutamine Impurity 19 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced analytical techniques such as HPLC, LC-MS, and NMR to ensure compliance with industry and client-specific standards. 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 tightly sealed in a dry environment to prevent degradation. For long-term storage, consider desiccants or inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Assay	≥ 98.0% (on anhydrous basis)
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.