Description

Avibactam Impurity 38 is a designated impurity reference standard used in the analytical profiling of the β-lactamase inhibitor, Avibactam. This compound is critical for pharmaceutical research and development, enabling the identification, quantification, and control of process-related impurities to ensure drug safety and efficacy. It is primarily required by quality control laboratories, regulatory affairs departments, and analytical scientists in the pharmaceutical and biotechnology industries for method validation and compliance with stringent regulatory guidelines.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the qualitative and quantitative analysis of Avibactam drug substance and finished products.
• Method Development and Validation: Essential for developing and validating stability-indicating HPLC, UPLC, or LC-MS methods in accordance with ICH guidelines.
• Quality Control and Batch Release: Used in routine QC testing to monitor impurity levels and ensure batches meet pre-defined specifications for purity.
• Regulatory Submission and Compliance: Provides necessary data for regulatory filings (e.g., FDA, EMA) to demonstrate thorough impurity characterization and control strategies.
• Stability Studies: Employed to identify and track degradation products formed under various stress conditions (e.g., heat, light, humidity).
• Process Chemistry Research: Aids chemists in optimizing synthesis pathways by identifying and minimizing the formation of this specific impurity.

Basic Information

Item	Details
Product Name	Avibactam Impurity 38
CAS No.	2241730-86-7
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	NXL-104 Impurity 38; AVI-IMP-38; Avibactam Related Compound 38; (2S,5R)-7-oxo-2-[(sulfooxy)amino]-1,6-diazabicyclo[3.2.1]octane-6-carboxylate Impurity; β-lactamase inhibitor impurity; 1,6-Diazabicyclo[3.2.1]octane impurity; Process impurity of Avibactam
EINECS	Contact for details

Quality Control

Every batch of Avibactam Impurity 38 is manufactured and analyzed under strict quality management systems. The product undergoes comprehensive analytical testing, including chromatographic purity (HPLC), identity confirmation (IR, MS), and residual solvent analysis to ensure it meets the high standards required for pharmaceutical 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 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 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.