Description

Bromfenac Sodium Impurity 2 is a specified impurity of the non-steroidal anti-inflammatory drug (NSAID) Bromfenac Sodium, identified by CAS NO 91714-43-1. This high-purity reference standard is critical for pharmaceutical research, development, and quality control, enabling accurate identification, quantification, and monitoring of this specific impurity during drug substance and product manufacturing. It is an essential material for analytical chemists and quality assurance professionals in the pharmaceutical industry who require reliable standards to ensure product safety, efficacy, and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the qualitative and quantitative analysis of Bromfenac Sodium.
• Method Development and Validation: Crucial for developing and validating analytical methods, particularly HPLC and LC-MS, for impurity profiling.
• Quality Control (QC) Testing: Used in routine QC laboratories to monitor and control the level of Impurity 2 in active pharmaceutical ingredients (APIs) and finished drug products.
• Stability Studies: Employed to track the formation and growth of this impurity under various stress and long-term storage conditions.
• Regulatory Submissions: Supports regulatory filings (e.g., for FDA, EMA) by providing necessary data on impurity identification and qualification.
• Research and Development: Aids in synthetic route optimization and process chemistry by helping to understand and minimize impurity formation.

Basic Information

Product Name	Bromfenac Sodium Impurity 2
CAS No.	91714-43-1
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Bromfenac Impurity 2; Bromfenac Related Compound 2; 2-Amino-3-(4-bromobenzoyl)benzoic Acid Impurity; Sodium (2-amino-3-(4-bromobenzoyl)phenyl)acetate Impurity; Bromfenac Sodium EP Impurity B; Bromfenac Sodium USP Related Compound; 91714-43-1; Bromfenac Degradation Product
EINECS	Contact for details

Quality Control

Our Bromfenac Sodium Impurity 2 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including advanced chromatographic techniques, to ensure high purity and accurate identification. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing purity, assay, and impurity profile. Our quality standards are designed to meet the stringent requirements of pharmaceutical reference materials, supporting compliance with ICH guidelines (Q3A, Q3B) and pharmacopeial standards.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C) or as indicated on the label. This compound is hygroscopic (moisture-sensitive); the container must be kept tightly sealed in a dry environment to prevent absorption of moisture. For long-term storage, consider storing under inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥ 95.0%
Purity (HPLC)	≥ 98.0%
Single Unknown Impurity	≤ 1.0%
Total Impurities	≤ 2.0%
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.