Description

Saccharin n-(2-Acetic Acid Isopropyl Ester)(Piroxicam Impurity F) is a high-purity chemical reference standard critical for analytical method development and quality control in pharmaceutical manufacturing. This compound serves as a specified impurity for the non-steroidal anti-inflammatory drug (NSAID) Piroxicam, making it essential for ensuring drug safety and regulatory compliance. It is primarily required by pharmaceutical R&D laboratories, quality assurance/quality control (QA/QC) departments, and contract research organizations (CROs) involved in API synthesis and impurity profiling.

Application

• Pharmaceutical Impurity Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Piroxicam Impurity F during drug substance and drug product analysis.
• Analytical Method Development & Validation: Essential for developing and validating stability-indicating HPLC, UPLC, or GC methods to monitor impurity levels in accordance with ICH guidelines.
• Quality Control & Batch Release: Employed in routine QA/QC testing to ensure Piroxicam API and finished dosage forms meet pharmacopoeial specifications (e.g., USP, EP) for impurity limits.
• Stability Studies: Used as an analytical marker in forced degradation and long-term stability studies to track impurity formation pathways in Piroxicam formulations.
• Regulatory Submissions: Provides necessary impurity characterization data for regulatory filings (e.g., ANDA, NDA, CMC documentation) with agencies like the FDA and EMA.
• Process Chemistry Research: Aids synthetic chemists in understanding and optimizing the Piroxicam manufacturing process to minimize the formation of this specific impurity.

Basic Information

Product Name	Saccharin n-(2-Acetic Acid Isopropyl Ester)(Piroxicam Impurity F)
CAS No.	76508-37-7
Molecular Formula	C16H18N2O5S
Molecular Weight	350.39 g/mol
Synonyms	Piroxicam Impurity F; Piroxicam Related Compound F; Saccharin N-(2-Acetoxyisopropyl) Ester; 2H-1,2-Benzothiazol-3-acetic acid, 1,1-dioxide, 2-(1-methylethyl) ester; Isopropyl 2-[(1,1-dioxido-3-oxo-1,2-benzothiazol-2(3H)-yl)]acetate; Piroxicam EP Impurity F; Piroxicam USP Impurity F
EINECS	Contact for details

Quality Control

Our Saccharin n-(2-Acetic Acid Isopropyl Ester) is manufactured under strict quality systems to ensure it meets the exacting standards required for pharmaceutical impurity analysis. Each batch is accompanied by a comprehensive Certificate of Analysis (COA) that includes data from orthogonal analytical techniques such as HPLC, GC, NMR, and MS for full structural confirmation and purity verification. We support compliance with ICH Q3A/B, USP, and European Pharmacopoeia guidelines for impurities.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. The material is hygroscopic (moisture-sensitive); ensure containers are sealed tightly after each use to prevent absorption of atmospheric moisture.

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)	Total impurities ≤ 2.0% Any individual unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 0.5%

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