3-Hydroxy Acetophenone

Details Specifications
CAS No.
121-71-1
Mol. Weight
136.15
Dosage Form
NA
Appearance
Light yellow to almost white powder to brown
Synonyms
1-(3-hydroxyphenyl)ethan-1-one
Storage
Preserve in well closed container and store at controlled room temperature
Available Regulatory Filling
Pending

Disclaimer: 

The information provided on this webpage is based on the best available knowledge at the time of publication; however, accuracy and completeness are not guaranteed. Product specifications may change without notice. It is the responsibility of the purchaser or user to verify suitability and compliance. This product is intended for research use only and is not approved for human consumption.

Shilpa Pharma proudly presents trans-4-[(2-amino-3,5-dibromobenzyl)amino]cyclohexanol hydrochloride, an active pharmaceutical ingredient (API) known in the industry by its CAS number 23828-92-4, and referred to as 3-Hydroxy Acetophenone within our product catalogue for strategic identification. This compound, with a molecular weight of 414.57, is a synthetic derivative characterized by its distinct dibromobenzyl and cyclohexanol moieties, crucial for its biological activity. Classified primarily within the anti-inflammatory therapeutic category, its mechanism of action is understood to involve mucolytic and secretolytic properties, facilitating the clearance of respiratory secretions and contributing to symptomatic relief in various inflammatory conditions of the respiratory tract. Adhering strictly to the European Pharmacopoeia (EP) standards, our offering ensures the highest levels of purity, quality, and regulatory compliance essential for pharmaceutical applications across regulated global markets. As a critical component in numerous therapeutic formulations, the reliable supply of this API is of paramount strategic importance to pharmaceutical manufacturers worldwide, supporting the consistent production of essential medicines. Shilpa Pharma is among the leading 3-Hydroxy Acetophenone manufacturers in India, providing a consistent supply of high-quality pharmaceutical APIs that meet rigorous international specifications. Our commitment extends beyond mere manufacturing; we provide comprehensive support to ensure our clients can confidently integrate our APIs into their product development and commercialization pipelines, backed by extensive regulatory documentation and technical expertise.

The API, identified as 3-Hydroxy Acetophenone (CAS 23828-92-4), finds extensive application in the formulation of various pharmaceutical products, predominantly within the respiratory therapeutic area. Its primary utility is in oral solid dosage forms such as tablets and capsules, as well as liquid formulations including syrups and oral solutions, where its mucolytic and secretolytic properties are harnessed. When formulating with this compound, careful consideration must be given to its solubility characteristics, which can vary with pH, impacting dissolution rates and bioavailability. Excipient compatibility studies are crucial to prevent undesired interactions that could compromise stability or efficacy. For oral solids, its compressibility profile is important for efficient tableting processes, often requiring specific binders and disintegrants to achieve desired tablet hardness and disintegration times. While primarily used in conventional release formulations, its chemical stability and pharmacokinetic profile also lend themselves to potential inclusion in modified-release systems, though this requires specialized formulation expertise to control drug release kinetics. Furthermore, it is often incorporated into combination products with other active ingredients, such as bronchodilators or antibiotics, to provide comprehensive treatment for respiratory ailments. Shilpa Pharma, as a dedicated 3-Hydroxy Acetophenone supplier from India, offers extensive support through our CDMO services, assisting clients with formulation development, process scale-up, and technology transfer to optimize product performance and manufacturing efficiency. Our technical teams are adept at addressing complex formulation challenges, ensuring the API behaves optimally within diverse matrices and dosage presentations.

Ensuring the integrity and safety of trans-4-[(2-amino-3,5-dibromobenzyl)amino]cyclohexanol hydrochloride, known as 3-Hydroxy Acetophenone (CAS 23828-92-4), necessitates strict adherence to specific storage and handling protocols. The API should be stored in tightly sealed containers, protected from light and moisture, ideally at controlled room temperature (typically 15-25°C), to maintain its chemical stability and prevent degradation. Our packaging solutions are designed to preserve the compound’s purity throughout its declared shelf life and retest period, which are established through rigorous stability studies in accordance with ICH guidelines. For personnel handling, appropriate personal protective equipment (PPE) including gloves, eye protection, and respiratory masks, along with adequate ventilation, is recommended to minimize exposure risks during manufacturing and handling operations. Known incompatibilities with strong oxidizing agents or highly acidic/alkaline environments must be avoided to prevent chemical reactions that could compromise product quality. In terms of regulatory classification, Shilpa Pharma ensures full compliance with international standards such as REACH for chemical registration and ICH Q3D for elemental impurities, providing comprehensive impurity profiling and residual solvent analysis to meet global pharmaceutical requirements. As a diligent 3-Hydroxy Acetophenone exporter India, we provide extensive quality documentation with every shipment, including a Certificate of Analysis (CoA), Certificate of Conformance, and Safety Data Sheet (SDS), offering complete transparency and assurance to industrial manufacturing personnel regarding product quality and safe handling practices.

The pricing structure for active pharmaceutical ingredients such as 3-Hydroxy Acetophenone (CAS 23828-92-4) is influenced by a confluence of critical factors that procurement directors and pharmaceutical manufacturers meticulously evaluate. Key determinants include the specified purity profile, the required batch size—with economies of scale often favoring larger commercial volumes—and the comprehensive regulatory documentation package, such as US-DMF or CEP, which adds significant value. The origin of the supply chain, raw material costs, and prevailing currency exchange rates also play a substantial role in the final quotation. Shilpa Pharma, as one of the established 3-Hydroxy Acetophenone manufacturers in India, offers highly competitive pricing without compromising on the stringent quality standards mandated by global regulatory bodies. Our strategic advantage stems from vertical integration, which provides greater control over the entire manufacturing process, from key intermediates to the final API. This reduces reliance on external suppliers, mitigates supply chain risks, and allows us to pass on cost efficiencies directly to our clients, a benefit often unavailable when sourcing through trading intermediaries. We accommodate all order sizes, from small research quantities essential for R&D to full commercial volumes, with flexible Minimum Order Quantities (MOQs) tailored to specific client needs. Furthermore, establishing long-term supply agreements with Shilpa Pharma offers pharmaceutical companies enhanced cost predictability and crucial supply chain stability, safeguarding against market volatility. To receive a tailored quotation or discuss supply requirements, buyers are encouraged to contact us directly.

Choosing Shilpa Pharma as your partner for trans-4-[(2-amino-3,5-dibromobenzyl)amino]cyclohexanol hydrochloride, referred to as 3-Hydroxy Acetophenone (CAS 23828-92-4), offers distinct advantages for pharmaceutical manufacturers, generic drug companies, CDMOs, and research organizations across the globe. Our manufacturing infrastructure in India is not only GMP-certified but also ISO-certified, reflecting our unwavering commitment to quality management systems and operational excellence. We provide comprehensive regulatory dossier capabilities, including US-DMF, CEP/EDMF, and COPP, facilitating expedited product registrations in highly regulated markets such as North America and Europe. Our state-of-the-art analytical capabilities, encompassing HPLC, GC, Karl Fischer titration, and particle size analysis, ensure meticulous quality control and detailed impurity profiling for every batch. Beyond API manufacturing, our extensive about Shilpa Pharma services include robust CDMO offerings, ranging from custom synthesis of niche intermediates to process scale-up and technology transfer, enabling seamless project progression from laboratory to commercial production. With decades of worldwide export experience across North America, Europe, Asia-Pacific, Latin America, the Middle East, and Africa, we possess an intricate understanding of global logistics and regulatory nuances. We provide dedicated technical support for formulation queries and post-sales assistance, ensuring our clients receive expert guidance throughout their product lifecycle. Our auditable supply chain guarantees transparency and traceability, while our straightforward procurement process, from initial inquiry to final delivery, is designed for maximum efficiency and client satisfaction. Shilpa Pharma stands as a premier 3-Hydroxy Acetophenone manufacturer and exporter, committed to being a reliable and strategic supplier.

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Questions & Answers

FAQ on 3-Hydroxy Acetophenone

Everything You Need to Know About Shilpa Pharma

Our 3-Hydroxy Acetophenone, specifically trans-4-[(2-amino-3,5-dibromobenzyl)amino]cyclohexanol hydrochloride, strictly adheres to the European Pharmacopoeia (EP) monographs. This ensures the API meets rigorous international quality, purity, and testing specifications. We provide comprehensive documentation to confirm compliance with EP standards.
Shilpa Pharma offers a complete suite of regulatory documents for 3-Hydroxy Acetophenone (CAS 23828-92-4). This includes US-DMF (Drug Master File), CEP/EDMF (Certificate of Suitability to the monographs of the European Pharmacopoeia), and COPP (Certificate of Pharmaceutical Product). These dossiers support our clients’ global registration efforts.
Absolutely, our CDMO services extend to custom synthesis of intermediates and specialty chemicals related to 3-Hydroxy Acetophenone. We possess the expertise and infrastructure to develop and scale up synthetic routes. Clients can discuss their specific requirements with our R&D team for tailored solutions.
For optimal stability, 3-Hydroxy Acetophenone should be stored in tightly sealed containers, protected from direct light and excessive moisture. A controlled room temperature range, typically 15-25°C, is recommended. These conditions help maintain its chemical integrity and extend its shelf life.
Lead times for commercial orders of 3-Hydroxy Acetophenone vary based on batch size, current production schedules, and specific client requirements. We strive for efficient delivery and can provide estimated timelines upon inquiry. Establishing long-term supply agreements often allows for more predictable scheduling and faster fulfillment.
Yes, comprehensive impurity profiling and residual solvent analysis are standard components of our quality control for 3-Hydroxy Acetophenone. Our analytical capabilities ensure compliance with ICH Q3A/B and ICH Q3C guidelines. We provide detailed Certificates of Analysis to confirm the purity and safety profile of each batch.
Shilpa Pharma maintains flexibility regarding Minimum Order Quantities (MOQs) for 3-Hydroxy Acetophenone. We accommodate various order sizes, from small research and development quantities to large commercial volumes. Please contact our sales team to discuss your specific volume requirements and receive a tailored quotation.
Our supply chain reliability for 3-Hydroxy Acetophenone is ensured through vertical integration and strategic sourcing of raw materials. We maintain robust inventory management systems and contingency plans to mitigate disruptions. Our global logistics network further supports timely and secure delivery to clients worldwide.
Yes, our CDMO services include extensive support for formulation development and process scale-up. Our expert teams can assist with excipient selection, solubility enhancement, and optimizing manufacturing parameters. We facilitate smooth technology transfer to ensure successful commercial production.
Absolutely, Shilpa Pharma operates a GMP-certified and ISO-certified manufacturing facility that is open to client audits. We encourage transparency and welcome potential partners to assess our quality systems, production processes, and regulatory compliance. Please reach out to schedule an audit.

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Please Note: We partner exclusively with pharmaceutical manufacturers, biotech companies, and international trading firms. Minimum order quantities apply*