Product Overview
Flurazepam monohydrochloride API is a key part of some medications. It belongs to the benzodiazepine family. This compound is pretty stable, and it’s used for making meds. This API has a reputation for consistency, purity, and a clear structure. It’s known for being reliable and well-organized. It’s usually managed with strict rules. This keeps things safe. It applies to production, storage, and making formulas in controlled spaces.
Therapeutic Applications
Pharmaceutical companies use Flurazepam monohydrochloride API. They make sedative-hypnotic medicines with it. It’s a key ingredient in these types of formulations. It is part of the benzodiazepine group of compounds. This API is great for creating oral medicines that are only needed for a short time. It is highly regarded for its stability. It gives you reliable quality and works well in formulas that need a controlled release and effects that last.
Specification Parameters
To define the purity of Flurazepam monohydrochloride API, there are quality parameters. These also check its identity and consistency. These parameters meet the required standards.
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Chemical Name (IUPAC): 7-chloro-1-[2-(diethylamino)ethyl]-5-(2-fluorophenyl)-1,3-dihydro-2H-1,4-benzodiazepin-2-one monohydrochloride
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CAS Number: 36105-20-1
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Molecular Formula: C₂₁H₂₃ClFN₃O · HCl
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Appearance: Pale yellow to off-white crystalline powder
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Identification Tests: Conforms to IR spectrum and HPLC retention time; positive chloride test
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Assay Method: RP-HPLC method; typically 98.0%–102.0% on dried basis
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Related Substances: Check using HPLC; keep individual and total impurities within pharmacopeial limits.
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Loss on Drying / Water Content: NMT 0.5% by LOD or as per Karl Fischer method
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Residue on Ignition: NMT 0.10%
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Residual Solvents (ICH Q3C): Class 1 avoided; Class 2 and 3 within acceptable ppm limits
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Elemental Impurities (ICH Q3D): Lead, cadmium, arsenic, mercury, and others must stay within set limits
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Microbial Limits: TAMC and TYMC are within limits, and specified pathogens are absent.
Packaging & Storage
Flurazepam mono hydrochloride API typically comes in fiber drums. The packaging keeps the API safe from moisture, air, and light. That’s a big help when it’s being stored or shipped. Store it somewhere cool and dry with a constant temperature. Use sealed, labeled containers stored in a dark place. Keep a record of how it’s handled and its batch.
Why Choose Us
Actiza Industry provides trusted API manufacturing services. We have great quality systems and up-to-date facilities. We also provide help with regulations and global supply solutions to support you.
Certified Quality
Actiza Industry sticks to WHO-GMP and ISO standards to keep its API production up to par. Each batch is made with careful control. We do proper testing and keep good records. We also do quality checks to ensure everything meets our standards.
Advanced Facility
Our factories are equipped with the latest machinery. The processing areas are really clean. Special areas for making stuff and controlled spaces are key to keeping API manufacturing safe. They help stop accidents from happening and make sure everything goes off without a hitch.
Regulatory Support
We’re here to help with global API rules. We also lend a hand with documentation. Our team helps with COA. We deal with technical documents and batch details. We also assist with compliance for markets with many rules and those with fewer.
Reliable Supply
Actiza Industry provides secure packaging, which is a top priority for us. We send orders out quickly. They are delivered reliably all over the world. We help customers run their business smoothly. We do this with strong supply chain management and flexible order sizes.
