Product Overview
Fluvoxamine maleate API is a clear pharmaceutical active ingredient. It’s got a stable chemical makeup. It’s built with tough rules in place to meet global standards. Many manufacturers use this API. They rely on it to create their formulations. It guarantees a pure result. Plus, it offers consistency and works well across different dosages.
Therapeutic Applications
Pharmaceutical companies use fluvoxamine maleate API. They make medicines that affect serotonin levels. They are called selective serotonin reuptake inhibitors or SSRIs. They’re built on formulations that use this API. This API is good for making oral solid forms. This is useful for creating CNS products. They have to be extremely pure, stable, and consistent in how they’re released.
Specification Parameters
Fluvoxamine maleate has certain parameters in place to make sure it’s genuine. It is safe for pharmaceutical use because of its high purity and stability.
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Chemical Name (IUPAC): (E)-5-Methoxy-4′-(trifluoromethyl)valerophenone O-(2-aminoethyl)oxime maleate (1:1)
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CAS Number: 61718-82-9
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Molecular Formula: C₁₉H₂₅F₃N₂O₆
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Molecular Weight: 434.41 g/mol
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Appearance: It’s color is usually white or off-white. It looks like a standard crystalline powder.
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Identification Tests:- HPLC retention time, IR spectrum test.
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Assay Method: HPLC (typically 98.0%–102.0% on dried basis)
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Related Substances / Impurities: Any unknown impurities must be 0.1% or less. The total amount of impurities is less than or equal to 1.0%.
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Elemental Impurities (ICH Q3D): Within permitted daily exposure limits
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Loss on Drying / Water Content: It should be less than or equal 0.5%.
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Microbial Limits: Not applicable (API), but controlled as per guidelines
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Sulphated Ash: must be no more than 0.1%
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Solubility: Dissolves easily in alcohol. It doesn’t dissolve as much in water.
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Residual Solvents: Meets ICH Q3C limits.
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Particle Size: Controlled (e.g., micronized for uniformity)
Packaging & Storage
Fluvoxamine maleate API comes in 25 kg drums. These drums are made of fiber or HDPE. It’s got two liners made of polyethylene. These liners keep moisture and contamination out. Containers are sealed tight and labeled for easy handling in industry. It should be stored somewhere cool. It should be dry with good airflow. To help it stay in good condition, keep it somewhere that isn’t too sunny or damp.
Why Choose Us
Actiza Pharma is a company you can count on to make and export Fluvoxamine Maleate API. We’re known for delivering quality. Our goal is to make sure supplies run smoothly and we’ve got solid regulatory backup.
Global Standards
Actiza Pharma values WHO-GMP and ISO guidelines. These guidelines help us make quality products. Our API facilities use great systems. We have careful quality checks and our production areas are clean. This mix keeps our products reliable and consistent.
Strong Manufacturing
Our modern plants use automated machines to make our work easier. We also have special zones for production. We also use advanced packaging systems. This allows us to supply Fluvoxamine Maleate API fast and accurately.
Regulatory Support
We help clients get their dossiers ready. This includes helping with CTDs, eCTDs, and ACTD documents. Our team is all set to support you in registering your product. We help buyers understand global compliance standards. We make it easier for them.
Reliable Supply
We ship to more than 50 countries, and that helps us run our supply chain pretty smoothly. We can also count on making our deliveries on time. Our vendor network is really solid, which helps keep production running smoothly.
