Product Overview
Flurazepam dihydrochloride is a benzodiazepine active pharmaceutical ingredient used in the production of regulated sedative and hypnotic medications. It is key to making regulated medications. It’s made with really high-quality standards. The purity is really tightly controlled, the composition stays the same, and the support you get is dependable. This API has good solubility and works well in batches. So, it’s great for pharmaceutical formulation and large-scale production.
Therapeutic Applications
Flurazepam dihydrochloride API plays an important role in the production of benzodiazepine medicines. It is a key ingredient that helps in the development of these types of drugs. This API is perfect for making oral solid dosage products. It ensures strict production standards. This API is valued for its stability. It’s reliable when it comes to processing. It also fulfills the needs of regulated pharmaceutical manufacturing when it comes to developing formulations.
Specification Parameters
Flurazepam dihydrochloride API is made to high standards. This ensures that making and producing medicines is dependable. It’s all about getting a reliable product in the end.
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Chemical Name (IUPAC): 7-chloro-1-[2-(diethylamino)ethyl]-5-(2-fluorophenyl)-3H-1,4-benzodiazepin-2-one dihydrochloride.
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CAS Number: 1172-18-5
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Molecular Formula: C21H23ClFN3O·2HCl
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Molecular Weight: 460.80 g/mol
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Appearance: Off-white to pale yellow crystalline powder
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Solubility: Freely soluble in water and alcohol
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Assay Method: HPLC or GC as per validated specifications
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Assay Range: Typically 99.0% to 101.0% on an anhydrous basis
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Identification Tests: HPLC, IR, UV, Chemical identification methods
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Related Substances / Impurities: Handled based on pharmacopeial quality rules.
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Residual Solvents: Meets ICH Q3C guideline requirements
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Elemental Impurities (ICH Q3D): Kept within approved regulatory limits.
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Loss on Drying / Water Content: Tested as per standard quality procedures
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Melting Range: Approximately 208°C to 218°C with decomposition
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Microbial Limits: Complies with specified microbial quality standards where applicable
Packaging & Storage
Flurazepam dihydrochloride API comes in strong HDPE drums. Each drum has two inner liners made of polyethylene. The packaging does a great job of protecting the material. It keeps moisture, light, and contamination out. This protection happens when the material is being transported or stored.
Why Choose Us
Actiza Industry is a reliable partner for API manufacturing. We have modern facilities and solid quality systems. This support helps us give safe, reliable, and affordable medicine to those who need it.
Advanced Facilities
At Actiza Industry, we’re all about using the latest machines and automated systems. We also prioritize keeping our production areas really clean. This helps us achieve our goal of reliable API manufacturing. We are happy to share that our facilities meet the WHO-GMP standards.
Quality Control
We perform thorough quality checks at each stage of production. Our skilled team checks purity. We also ensure proper packaging and clear documentation. This helps us deliver Flurazepam dihydrochloride API batches.
Global Compliance
Actiza Industry takes care of global pharmaceutical needs. We offer regulatory documents and export services to help out. Our manufacturing process is in line with global standards. This means customers can easily meet market and registration rules.
Research Support
Our research and development team works hard. They improve processes and boost manufacturing efficiency. This lets us provide solid API solutions. We are all about being consistent, having a steady supply, and delivering strong production results.
