Description

Azlocillin Opern-Ring Impurity is a key chemical reference standard used in the analytical profiling and quality control of the antibiotic Azlocillin. This compound is critical for pharmaceutical manufacturers and research laboratories to identify, quantify, and control process-related impurities, ensuring the safety and efficacy of the final drug product. It is an essential tool for professionals engaged in method development, stability studies, and regulatory compliance within the pharmaceutical and analytical chemistry sectors.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material for the identification and quantification of the open-ring degradant in Azlocillin API and finished dosage forms.
• Analytical Method Development & Validation: Serves as a critical standard for developing and validating stability-indicating HPLC, UPLC, or LC-MS methods.
• Quality Control & Assurance (QC/QA): Employed in routine batch testing to monitor impurity levels and ensure compliance with pharmacopeial standards (e.g., USP, EP, ICH Q3A/B).
• Stability Studies: Used to track the formation of this specific degradation product under various stress conditions (e.g., heat, humidity, pH).
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Research & Development: Facilitates studies on the degradation pathways and chemical stability of penicillin-based antibiotics.

Basic Information

Item	Detail
Product Name	Azlocillin Opern-Ring Impurity
CAS No.	96688-41-4
Molecular Formula	C20H23N5O6S
Molecular Weight	461.49 g/mol
Synonyms	(2S,5R,6R)-6-[[(2R)-2-Amino-2-phenylacetyl]amino]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid; 6-(D-2-Amino-2-phenylacetamido)penicillanic acid; Azlocillin Open Chain Impurity; Azlocillin Degradant; Azlocillin Related Compound A; Penicilloic Acid Derivative of Azlocillin; D-α-Aminobenzylpenicilloic Acid
EINECS	Contact for details

Quality Control

Every batch of Azlocillin Opern-Ring Impurity (CAS 96688-41-4) is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity testing using advanced techniques like HPLC and LC-MS to ensure compliance with industry standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for purity, related substances, and residual solvents.

Storage

Preserve in a tightly closed container, protected from light. For long-term stability, store at 2-8°C in a dry environment. The material is hygroscopic (moisture-sensitive). Allow the sealed vial to equilibrate to room temperature before opening to prevent condensation.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any single unknown impurity ≤ 1.0%
Water Content (KF)	≤ 5.0% w/w
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.