Product Overview
Quetiapine Fumarate API is an active ingredient from the dibenzothiazepine class.
It generally appears as a white to off-white crystalline powder.
This API is made under controlled conditions. It meets key pharmacopeial standards such as USP, BP, and IP.
This product is a great fit for regulated pharma manufacturing and formulation development.
Therapeutic Applications
Quetiapine Fumarate API is used to produce solid oral drugs for the central nervous system.
This dibenzothiazepine-class API is great for formulations that need to be stable, pure, and consistent.
It helps companies make branded and generic medicines following approved rules.
Specification Parameters
To ensure the quality of Quetiapine Fumarate API, focus on its specification parameters.
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Chemical Name: 2-[2-(4-dibenzo[b,f][1,4]thiazepin-11-yl-1-piperazinyl)ethoxy]ethanol hemifumarate
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CAS Number: 111974-72-2
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Molecular Formula: C₄₆H₅₄N₆O₈S₂
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Appearance: White to off-white crystalline powder
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Identification Tests: IR spectroscopy, HPLC retention time
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Assay Method: HPLC
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Assay Range: As per pharmacopeial limits
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Related Substances / Impurities: Managed with approved HPLC methods.
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Residual Solvents: Complies with ICH Q3C limits
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Elemental Impurities: Meet ICH Q3D requirements.
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Loss on Drying / Water Content: NMT pharmacopoeial limit
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Particle Size Distribution: Controlled for formulation suitability
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Polymorphic Form: As specified by manufacturing control.
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Microbial Limits: Meet USP/EP microbial standards.
Packaging & Storage
Quetiapine Fumarate API comes packaged in HDPE or fiber drums.
Drums are labeled to limit exposure to air and moisture.
Then, they are stored in a cool, dry place, away from sunlight and heat. This helps maintain API quality and stability.
Why Choose Us
At Actiza Industry, we are committed to delivering the best quality Quetiapine Fumarate API.
We focus on good quality systems and modern facilities.
Quality Systems
Our API manufacturing meets strict GMP standards. We use controlled processes, tested methods, and clear documentation.
This maintains quality, purity, and compliance across every production batch.
Advanced Facilities
We run modern, well-equipped manufacturing plants.
We use advanced systems, clean areas, and strict controls to create a safe and efficient environment.
This helps us produce Quetiapine Fumarate API on a large scale.
Integrated Supply
Backward integration and a solid vendor network ensure we have a steady supply of raw materials.
This approach helps us run smoothly. It also ensures our customers receive their deliveries on time.
Regulatory Support
Actiza Industry offers full regulatory and dossier support.
We assist partners in meeting global filing needs.
We provide accurate documents, technical data, and a dependable long-term API supply.
