N-(3,4-dimethoxyphenethyl)-2-(3,4-dimethoxyphenyl)acetamide

N-(3,4-Dimethoxyphenethyl)-2-(3,4-dimethoxyphenyl)acetamide is the officially designated European Pharmacopoeia (EP) impurity standard for papaverine hydrochloride — a smooth muscle relaxant extracted from opium and clinically used as a cerebral and coronary vasodilator. In the Papaverine Hydrochloride EP monograph, N-(3,4-Dimethoxyphenethyl)-2-(3,4-dimethoxyphenyl)acetamide is defined as Impurity F, making it a critical analytical reference material for pharmaceutical quality control laboratories, CROs, and generic drug manufacturers worldwide. The biological relevance of N-(3,4-Dimethoxyphenethyl)-2-(3,4-dimethoxyphenyl)acetamide extends beyond its role as an impurity, as it is also recognized as a potential synthetic scaffold for exploring interactions with calcium channels and P2X7 receptors, with research suggesting possible anti‑inflammatory and analgesic activity. For pharmaceutical manufacturers preparing Abbreviated New Drug Applications (ANDA) or New Drug Applications (NDA) for papaverine hydrochloride, N-(3,4-Dimethoxyphenethyl)-2-(3,4-dimethoxyphenyl)acetamide is an indispensable tool for impurity profiling, analytical method validation, stability monitoring and batch‑to‑batch quality control. The symmetrical dimethoxyphenyl architecture of N-(3,4-Dimethoxyphenethyl)-2-(3,4-dimethoxyphenyl)acetamide also enables its use in preparative HPLC isolation, method development for pharmacopoeial compliance and the establishment of reference standard traceability for regulatory submissions.

Product Parameters

Why Cosperpharm?

When regulatory auditors review your impurity control strategy, the traceability of your reference standards matters as much as the analytical data itself. Cosperpharm delivers certified reference materials that stand up to scrutiny.

Traceable certification, not just a COA. Our N-(3,4-Dimethoxyphenethyl)-2-(3,4-dimethoxyphenyl)acetamide (Papaverine Hydrochloride EP Impurity F) is supplied with a comprehensive Certificate of Analysis that includes HPLC purity (>95%, with full chromatographic traceability), mass spectrometry confirmation (MS) of molecular identity, water content (Karl Fischer) and residual solvent data — organized for seamless insertion into your regulatory documentation folder.

Pharmacopoeial alignment out of the box. This reference standard is precisely the impurity defined in the European Pharmacopoeia (EP) monograph for papaverine hydrochloride. Unlike generic “research grade” material that may not match monograph specifications, Cosperpharm‘s material is pre‑qualified for method validation, system suitability testing and impurity profiling exactly as regulators expect — reducing your qualification burden.

Stability data you can file. Each batch is supported by ongoing long‑term stability data (2–8 °C) and accelerated stability summaries. For customers filing ANDAs or NDAs, we provide DMF‑ready documentation packages, method validation support and custom quality agreements — all organized to streamline your submission.

Flexible reference standard quantities. Cosperpharm supplies N-(3,4-Dimethoxyphenethyl)-2-(3,4-dimethoxyphenyl)acetamide in pack sizes ranging from 25mg analytical reference standards to 25g bulk reference material for ongoing QC programs. Custom packaging under inert atmosphere is available for customers requiring material for stability chambers or long‑term retention sample storage.

A partner who understands generic timelines. We know that method development and regulatory submissions cannot wait. Cosperpharm maintains inventory across standard pack sizes, with routine reference standard quantities shipping within 5–7 business days and expedited options available for urgent requirements. Our team can guide you through the qualification process for USP/EP alignment based on your specific project needs.

FAQ

Q1: How should this reference standard be stored?

A: Store sealed in a tightly closed container under refrigerated conditions at 2–8 °C. Keep the container dry and protected from light. The material is stable under recommended storage conditions. For long‑term retention samples in stability chambers, maintain the same storage conditions and minimize opening of the container to prevent moisture ingress.

Q2: What is the shelf life of this reference standard?

A: Under recommended storage conditions (sealed, 2–8 °C, dry, protected from light), N-(3,4-Dimethoxyphenethyl)-2-(3,4-dimethoxyphenyl)acetamide has an effective period of 3 years from the date of manufacture. Stability study data supporting this shelf life claim is available upon request.

Storage Conditions

Store N-(3,4-Dimethoxyphenethyl)-2-(3,4-dimethoxyphenyl)acetamide in a tightly sealed container under refrigerated conditions at 2–8 °C (do not freeze). Keep the container dry, protected from light, and stored in a clean, well‑ventilated area away from strong oxidizers, strong acids and sources of ignition. The crystalline solid is stable under recommended storage conditions and is not highly hygroscopic.

For long‑term storage exceeding 12 months, maintain the material in its original container and minimize the frequency of opening to prevent any possibility of moisture ingress. Retention samples stored for stability monitoring should be kept under identical conditions.

Shelf life: 3 years when stored as recommended in a sealed container under refrigerated conditions. Accelerated stability data (40 °C / 75 % RH) and long‑term stability summaries are available upon request to support your regulatory filing.

Contact us:

Ready to secure a certified supply of N-(3,4-Dimethoxyphenethyl)-2-(3,4-dimethoxyphenyl)acetamide (Papaverine Hydrochloride EP Impurity F) for your papaverine hydrochloride method validation, stability program or regulatory filing?we are happy to help you evaluate our documentation against your regulatory expectations before you commit.