Sildenafil N-Oxide | CAS 1094598-75-0 | Impurity Standard

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Blue Eye Bio is a trusted authoritative source for high-purity Sildenafil N-Oxide (CAS 1094598-75-0). As a critical Pharmaceutical Impurity Standard, this compound is indispensable for global Quality Control (QC), stability profiling, and analytical method validation.
Managed under British technical oversight and produced through our Strategic Supply Chain Alliance, we ensure that every batch meets the rigorous analytical benchmarks required by global pharmaceutical R&D labs.
We prioritize the needs of Small and Medium-sized Enterprises by providing comprehensive technical dossiers, including batch-specific COA, 1H-NMR, and Mass Spectrometry (LC-MS) spectra. This ensures total molecular traceability and reliable calibration for your HPLC systems. Request a rapid 24-hour quote today.
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Sildenafil N-Oxide (Pharmaceutical Impurity Standard)


"In the rigorous world of pharmaceutical manufacturing, controlling the impurity profile is non-negotiable. Sildenafil N-Oxide (CAS 1094598-75-0) is a critical degradation product formed via the oxidation of the sildenafil molecule.

At Blue Eye Bio, we provide this Impurity Standard with ultra-high purity, enabling global manufacturers and analytical laboratories to conduct precise Method Validation and stability testing. Governed by our British technical oversight, we ensure every gram supports your regulatory compliance goals."





1. Detailed Specification Table


Analysis Item

Specification Standard

Method / Note

Common Name

Sildenafil N-Oxide

--

CAS Number

1094598-75-0

--

Molecular Formula

C22H30N6O5S

Theoretical

Assay (Purity)

≥ 98.0% / ≥ 99.0%

HPLC Verified

Physical Form

Off-white to Tan Solid/Powder

Visual

Isotope Labeling

Also available in D3/D8 forms

Specialized R&D

Technical Data

NMR, MS, HPLC Spectra Provided

Technical Dossier






2.Technical Role: Impurity Profiling and Regulatory CMC Support(Why need Sildenafil N-Oxide?)


"Sildenafil N-Oxide (CAS 1094598-75-0) is categorized as a known impurity in sildenafil-based formulations. For pharmaceutical companies following ICH guidelines, it is mandatory to identify and quantify this substance during Accelerated Stability Studies and final batch release.

Utilizing Blue Eye Bio’s high-purity standard allows analytical chemists to accurately calibrate their HPLC systems, ensuring that the degradation markers are precisely identified, thus supporting the CMC (Chemistry, Manufacturing, and Controls) section of your regulatory filing."







3.Industrial & Analytical Applications


    • QC Reference Material: Used as an external standard for the daily quality control of Sildenafil Citrate bulk drug and finished dosages.

    • Forced Degradation Studies: A vital tool for researchers simulating extreme storage conditions to map the chemical stability of the molecule.

    • Pharmacopoeia Compliance: Supporting labs in meeting USP, EP, and BP purity requirements for vasodilatory agents.








Why choose Blue Eye Bio



    • Analytical Sovereignty: Unlike general chemical distributors, we provide First-hand Technical Data. Every batch is verified in our Asia-based Manufacturing Hub with final audit by our UK compliance team.

    • Flexible Sourcing for Small and Medium-sized Enterprises: We understand that high-end standards are often needed in milligram quantities. We offer Flexible MOQ tailored for independent research labs and Small and Medium-sized Enterprises.

    • Rapid 24-hour Response: Time-sensitive R&D cannot wait. Get your formal quote and batch spectra (NMR/MS) within one business day.



Looking for the parent API? View our [Sildenafil Citrate] series.


Need the active metabolite? See [N-Desmethyl Sildenafil] (UK-92480).


  • Q: Why is Sildenafil N-Oxide purity critical for LC-MS analysis?

      • A: As an Impurity Standard, its role is to be the "absolute ruler." If the standard itself contains impurities, it leads to skewed results in your analytical validation. Blue Eye Bio ensures zero carry-over of sildenafil, providing a clean signal for your LC-MS/MS profiling.

  • Q: Does Blue Eye Bio provide the COA for CAS 1094598-75-0?

      • A: Yes. Every order of our Sildenafil N-Oxide is accompanied by a batch-specific Certificate of Analysis (COA), detailing the purity by HPLC and confirming the molecular identity via 1H-NMR and Mass Spectrometry.

  • Q: How do you support Small and Medium-sized Enterprises in the pharma sector?

      • A: We act as your Strategic Extension. We offer small-volume packaging (mg to gram scale) and provide the technical consultation needed to integrate our specialty ingredients into your R&D pipelines.




Compliance & Support

GMP, ISO, HALAL, KOSHER, FDA Registered.

Full technical dossiers (MSDS, TDS, COA, Allergen Statement) are available for every batch.