Description

Carglumic Acid Impurity 1 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and efficacy of the active pharmaceutical ingredient, Carglumic Acid, through precise impurity profiling and method validation. It is an essential material for pharmaceutical manufacturers, analytical laboratories, and regulatory bodies focused on compliance and quality control. The reliable identification and quantification of this impurity are fundamental to meeting stringent pharmacopeial standards.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for the identification and quantification of impurities in Carglumic Acid drug substance and finished products.
• Analytical Method Development & Validation: Critical for developing, optimizing, and validating HPLC, UPLC, or LC-MS methods in quality control laboratories.
• Stability Studies: Used to monitor the formation and levels of this specific impurity during forced degradation and long-term stability testing of pharmaceutical formulations.
• Regulatory Compliance & Filing: Supports regulatory submissions (e.g., to FDA, EMA) by providing necessary impurity data for drug master files (DMFs) and new drug applications (NDAs).
• Quality Control Testing: Serves as a system suitability and calibration standard in routine batch release testing of Carglumic Acid to ensure specification limits are met.
• Research & Development: Used in synthetic chemistry R&D to study impurity formation pathways and to develop purification processes for the active pharmaceutical ingredient.

Basic Information

Product Name	Carglumic Acid Impurity 1
CAS No.	2380660-24-0
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Carglumic Acid Related Compound 1; Carglumic Acid Impurity; N-Carbamoyl-L-glutamic Acid Impurity 1; (4S)-4-[[(Aminocarbonyl)amino]carbonyl]-4-aminopentanedioic Acid Impurity; CARGLUMIC Impurity A; CARGLUMIC Impurity 1; CARBA-GLU Impurity 1
EINECS	Contact for details

Quality Control

Our Carglumic Acid Impurity 1 is manufactured under strict quality systems to ensure it meets the exacting requirements for a pharmaceutical reference standard. Each batch undergoes comprehensive analytical testing, including identity confirmation by spectroscopic methods (IR, NMR, MS) and purity determination by advanced chromatographic techniques (HPLC, UPLC). A Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results and confirming compliance with specified purity grades. Our quality commitment aligns with ICH Q3A, Q3B, and Q6A 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 in a desiccated environment to maintain stability and purity. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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