Description

Bromfenac Sodium Impurity Z1 is a specified impurity and reference standard used in the analytical profiling of the non-steroidal anti-inflammatory drug (NSAID) Bromfenac Sodium. This compound is critical for ensuring the quality, safety, and efficacy of the active pharmaceutical ingredient (API) by providing a benchmark for identification and quantification during quality control testing. It is an essential material for pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in research, development, and compliance testing of ophthalmic and other formulations containing Bromfenac Sodium.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of Impurity Z1 in Bromfenac Sodium API and finished drug products.
• Analytical Method Development & Validation: Critical for developing, optimizing, and validating HPLC, UPLC, or LC-MS methods to monitor impurities in compliance with ICH Q3A(R2) and Q3B(R2) guidelines.
• Quality Control & Batch Release: Used in routine QC testing to establish impurity profiles, ensure batch-to-batch consistency, and confirm that impurity levels are within specified limits.
• Stability Studies: Employed to track the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity) as part of drug stability testing programs.
• Regulatory Submissions: Essential for preparing regulatory documentation (e.g., CMC sections for FDA, EMA) to demonstrate comprehensive impurity control strategies.
• Research on Degradation Pathways: Serves as a key marker in studies investigating the chemical stability and degradation mechanisms of Bromfenac Sodium.

Basic Information

Product Name	Bromfenac Sodium Impurity Z1
CAS No.	91715-34-3
Molecular Formula	C15H12BrNO3Na
Molecular Weight	357.16 g/mol
Synonyms	2-Amino-3-(4-bromobenzoyl)benzenesodium acetate; Bromfenac Impurity Z1; Bromfenac Sodium Related Compound Z1; Sodium 2-[2-amino-3-(4-bromobenzoyl)phenyl]acetate; Bromfenac EP Impurity Z; Bromfenac USP Impurity Z1; Bromfenac Sodium Degradation Product Z1
EINECS	Contact for details

Quality Control

Every batch of Bromfenac Sodium Impurity Z1 is manufactured and handled under strict quality management systems. The material undergoes comprehensive analytical characterization using techniques including HPLC, LC-MS, NMR, and IR to confirm identity and purity. A detailed Certificate of Analysis (COA) is provided with each lot, reporting the results against predefined specifications. Our quality commitment aligns with the standards required for pharmaceutical reference materials, supporting compliance with cGMP, ICH, and pharmacopeial guidelines (USP, EP).

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 should be handled in a low-humidity environment to prevent degradation. For long-term storage, consider desiccants and inert atmosphere conditions.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.5%

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