Description

Ketorolac Ep Impurity F is a high-purity reference standard used for analytical and quality control purposes in pharmaceutical development and manufacturing. This compound is critical for ensuring the safety and efficacy of the non-steroidal anti-inflammatory drug (NSAID) Ketorolac by accurately identifying and quantifying this specific impurity. It is an essential material for analytical chemists and quality assurance professionals in pharmaceutical companies, contract research organizations (CROs), and regulatory testing laboratories focused on method validation and compliance with stringent pharmacopeial standards.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of Ketorolac Ep Impurity F in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development & Validation (HPLC/LC-MS): Critical for developing, optimizing, and validating chromatographic methods to monitor impurity profiles in accordance with ICH Q3A(R2) and Q3B(R2) guidelines.
• Quality Control & Batch Release Testing: Used in routine QC laboratories to ensure Ketorolac drug substances and products meet specified impurity limits for regulatory filings and market release.
• Stability Studies: Employed to track the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity) as part of forced degradation and shelf-life studies.
• Regulatory Submissions: Supports the preparation of Chemistry, Manufacturing, and Controls (CMC) documentation for regulatory agencies like the US FDA, EMA, and others.
• Pharmacopeial Testing: Serves as a system suitability standard for testing procedures outlined in pharmacopeias such as USP (United States Pharmacopeia) and EP (European Pharmacopoeia).

Basic Information

Product Name	Ketorolac Ep Impurity F
CAS No.	1391052-68-8
Molecular Formula	C15H13NO3
Molecular Weight	255.27 g/mol
Synonyms	Ketorolac Impurity F; Ketorolac Related Compound F; 5-Benzoyl-2,3-dihydro-1H-pyrrolizine-1-carboxylic Acid; (1RS,5SR)-5-Benzoyl-2,3-dihydro-1H-pyrrolizine-1-carboxylic Acid; Ketorolac EP Impurity F; Ketorolac Tromethamine Impurity F; Ketorolac Degradation Product; Ketorolac Process Impurity
EINECS	Contact for details

Quality Control

Every batch of Ketorolac Ep Impurity F is manufactured under controlled conditions and undergoes rigorous analytical testing to ensure identity, purity, and consistency. Our quality assurance protocols are designed to meet the exacting standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results from tests including identification (IR, HPLC), assay (HPLC), and related substance analysis. We support compliance with ICH guidelines and relevant 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). This product is hygroscopic (moisture-sensitive) and should be handled in a low-humidity environment to prevent degradation. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 0.5%
Water Content (KF)	≤ 1.0% w/w
Residue on Ignition	≤ 0.1%

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