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Tiaprofenic Acid Impurity C CAS NO 78239-47-1


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CAS No.:78239-47-1

Grade:Pharmacy Grade

Content:99.9%

Brand:Customizable

Packaging:Customizable

Description

Tiaprofenic Acid Impurity C CAS NO 78239-47-1 is a high-purity chemical reference standard used for analytical and quality control purposes. This compound is critical for ensuring the purity, safety, and efficacy of the non-steroidal anti-inflammatory drug (NSAID) Tiaprofenic Acid during its development and manufacturing. It is primarily required by pharmaceutical R&D laboratories, quality assurance/quality control (QA/QC) departments, and regulatory affairs teams. The availability of a well-characterized impurity standard is essential for method validation, stability studies, and meeting stringent global regulatory requirements.

Application

  • Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of Tiaprofenic Acid Impurity C in active pharmaceutical ingredient (API) batches.
  • Analytical Method Development & Validation (HPLC/GC): Used as a critical component in developing and validating chromatographic methods for impurity profiling.
  • Quality Control & Batch Release Testing: Essential for routine QA/QC testing to ensure Tiaprofenic Acid API complies with pharmacopeial (e.g., USP, EP) and ICH Q3A/B guidelines on impurities.
  • Stability Studies & Forced Degradation: Employed to monitor the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity).
  • Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
  • Research & Development: Used in synthetic chemistry research to study impurity formation pathways and develop purification processes.

Basic Information

Item Details
Product Name Tiaprofenic Acid Impurity C
CAS No. 78239-47-1
Molecular Formula C14H12O3S
Molecular Weight 260.31 g/mol
Synonyms 5-Benzoyl-2-thiopheneacetic Acid; 2-(5-Benzoyl-2-thienyl)acetic Acid; Tiaprofenic Acid Related Compound C; Tiaprofenic Acid Degradant; Benzoylthiopheneacetic Acid; α-(5-Benzoyl-2-thienyl)acetic Acid; 2-(5-Benzoylthiophen-2-yl)acetic Acid
EINECS Contact for details

Quality Control

Every batch of Tiaprofenic Acid Impurity C is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical testing, including HPLC for purity and identity confirmation via spectroscopic methods (IR, NMR), to ensure compliance with high-grade reference standard specifications. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for identity, assay, purity, and related substances. We support compliance with ICH, USP, and EP guidelines for impurity 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); therefore, 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 powder
Identification (IR) Conforms to structure
Identification (HPLC) Retention time matches reference standard
Purity (HPLC) ≥ 98.0%
Related Substances (HPLC) Any individual impurity: ≤ 1.0% Total impurities: ≤ 2.0%
Water Content (KF) ≤ 0.5%
Residue on Ignition ≤ 0.1%

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

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