Description

Avibactam Impurity 19 is a specified impurity of the β-lactamase inhibitor, Avibactam, identified by the CAS number 1383814-72-9. This high-purity reference standard is critical for pharmaceutical research and development, enabling the accurate identification, quantification, and control of this impurity during drug substance manufacturing. It is an essential material for quality assurance and regulatory compliance in the production of Avibactam and its combination drug products. Analytical chemists and quality control laboratories in the pharmaceutical industry rely on this standard to ensure product safety and efficacy.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the qualitative and quantitative analysis of Avibactam Impurity 19 in active pharmaceutical ingredient (API) batches.
• Method Development and Validation: Critical for developing and validating robust analytical methods, such as HPLC and UPLC, for impurity profiling in compliance with ICH Q3A(R2) and Q3B(R2) guidelines.
• Quality Control & Release Testing: Used in routine QC testing to monitor and control impurity levels, ensuring the final drug substance meets stringent pharmacopeial specifications (e.g., USP, EP).
• Stability Studies: Employed to track the formation and growth of this specific impurity over time under various stress conditions, supporting shelf-life determination.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., FDA, EMA) to establish impurity thresholds and justify specifications in Drug Master Files (DMFs) and Common Technical Documents (CTDs).
• Process Chemistry Research: Aids chemists in understanding and optimizing the synthetic pathway of Avibactam to minimize the formation of this impurity.

Basic Information

Product Name	Avibactam Impurity 19
CAS No.	1383814-72-9
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	NXL-104 Impurity 19; (2S,5R)-7-oxo-2-[(sulfooxy)methyl]-1,6-diazabicyclo[3.2.1]octan-6-yl hydrogen sulfate (Impurity of Avibactam); AVI Impurity 19; Avibactam Related Compound 19; UNII-9H8L1L8T8B (component); Diazabicyclooctane sulfate impurity; β-lactamase inhibitor impurity.
EINECS	Contact for details

Quality Control

Every batch of Avibactam Impurity 19 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced techniques like HPLC, NMR, and MS to ensure compliance with industry standards for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results. We support compliance with cGMP, ICH, and relevant pharmacopeial guidelines where applicable.

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 compound is hygroscopic (moisture-sensitive); the container must be kept tightly sealed in a dry environment to prevent degradation. 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%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Assay	90.0% - 110.0% (on anhydrous basis)

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