Description

Imp. D (Ep): (2S)-2-(5-Iodo-6-Methoxynaphthalen-2-Yl)Propanoic Acid (5-Iodonaproxen) is a high-purity, non-steroidal anti-inflammatory drug (NSAID) impurity and a key iodinated derivative of Naproxen. This compound is of critical importance for pharmaceutical research and development, serving as a certified reference standard for analytical method development and validation. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and research institutions focused on quality control, stability studies, and regulatory compliance for naproxen-based drug products.

Application

• Pharmaceutical Reference Standard: Certified impurity standard (Impurity D) for the analysis of Naproxen drug substances and finished products as per European Pharmacopoeia (EP) and other pharmacopoeial monographs.
• Analytical Method Development & Validation (HPLC/LC-MS): Used to develop, validate, and verify chromatographic methods for the identification and quantification of process-related impurities and degradation products.
• Stability Indicating Method: Essential for forced degradation studies to understand the stability profile of naproxen formulations and to establish shelf-life.
• Quality Control & Batch Release Testing: Employed in routine QC laboratories to ensure drug substance and product purity meets stringent regulatory specifications.
• Metabolite & Pharmacokinetic Research: Useful as a chemical reference in studies investigating the metabolism and distribution of iodinated naproxen analogs.
• Regulatory Submissions: Supports the filing of drug dossiers (e.g., ANDA, NDA) with agencies like the FDA and EMA by providing necessary impurity characterization data.

Basic Information

Product Name	Imp. D (Ep): (2S)-2-(5-Iodo-6-Methoxynaphthalen-2-Yl)Propanoic Acid (5-Iodonaproxen)
CAS No.	116883-61-5
Molecular Formula	C₁₄H₁₃IO₃
Molecular Weight	356.16 g/mol
Synonyms	(S)-2-(5-Iodo-6-methoxy-2-naphthyl)propionic Acid; 5-Iodo-6-methoxy-2-naphthalenepropanoic Acid, (αS)-; 5-Iodonaproxen; Naproxen Impurity D (EP); (2S)-2-(5-Iodo-6-methoxynaphthalen-2-yl)propanoic Acid; European Pharmacopoeia Impurity D of Naproxen; (S)-5-Iodonaproxen
EINECS	Contact for details

Quality Control

Every batch of 5-Iodonaproxen (Impurity D) is manufactured and controlled under a strict quality management system. The product is characterized and tested against high-purity reference standards to ensure identity, potency, and purity as required for pharmacopoeial applications. Comprehensive testing includes HPLC purity, chiral purity, residual solvent analysis, and identity confirmation (IR, MS). A detailed Certificate of Analysis (COA) is provided with each shipment, containing batch-specific results.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. The compound is light-sensitive (store away from light). For long-term storage, consider storing desiccated under inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	≥ 98.0%
Chiral Purity (HPLC)	≥ 99.0% (S-enantiomer)
Related Substances (HPLC)	Any individual impurity ≤ 0.5%; Total impurities ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Loss on Drying	≤ 0.5%

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