Details | Specifications |
|---|---|
CAS Number |
23828-92-4 |
Molecular Formula |
C13H18Br2N2O.HCl |
Molecular Weight |
414.57 |
Synonyms |
4-[(2-amino-3,5-dibromophenyl)methylamino]cyclohexan-1-ol |
Chemical Name |
trans-4-[(2-amino-3,5-dibromobenzyl)amino]cyclohexanol hydrochloride |
Grade |
EP |
Polymorph |
No-polymorphic form reported |
GTI and NI |
Yes |
DMF Availability |
Yes |
Please Note: We partner exclusively with pharmaceutical manufacturers, biotech companies, and international trading firms. Minimum order quantities apply*Â
Disclaimer:Â
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 Ambroxyl Hydrochloride, CAS Number 23828-92-4, a highly sought-after active pharmaceutical ingredient (API) crucial for the formulation of various pharmaceutical products. Chemically identified as trans-4-[(2-amino-3,5-dibromobenzyl)amino]cyclohexanol hydrochloride, this compound is classified structurally as a brominated benzylamine derivative, characterized by its cyclohexanol ring and dibrominated phenyl moiety. With a precise molecular weight of 414.57, Ambroxyl Hydrochloride functions primarily within the therapeutic category as a mucolytic agent, playing a vital role in respiratory medicine.
At a molecular level, Ambroxyl Hydrochloride exerts its therapeutic effect by depolymerizing mucopolysaccharides, thereby reducing the viscosity of bronchial secretions. This action facilitates the clearance of mucus from the respiratory tract, providing symptomatic relief in conditions associated with excessive or tenacious mucus. Its mechanism involves the hydrolysis of acid mucopolysaccharide fibers, leading to thinner, less viscous mucus that is easier to expectorate. As a leading manufacturer and exporter of pharmaceutical APIs, Shilpa Pharma ensures that our Ambroxyl Hydrochloride meets the stringent quality requirements of the European Pharmacopoeia (EP), guaranteeing its suitability for global pharmaceutical applications.
The strategic importance of Ambroxyl Hydrochloride to pharmaceutical manufacturers globally cannot be overstated. Its efficacy in managing respiratory conditions makes it a foundational component for numerous formulations aimed at improving patient quality of life. Shilpa Pharma, recognized among the premier Ambroxyl Hydrochloride manufacturers in India, is committed to supplying this critical API with unwavering quality, backed by our ISO and GMP certifications. Our commitment extends to providing comprehensive regulatory support, including US-DMF, CEP/EDMF, and COPP, enabling our clients to navigate complex international regulatory landscapes with confidence and efficiency.
Ambroxyl Hydrochloride, with its well-established mucolytic properties, finds extensive application across various pharmaceutical formulations designed to address respiratory ailments. This API is predominantly incorporated into oral dosage forms such as tablets, capsules, and oral solutions or syrups, where its systemic absorption facilitates its action on bronchial secretions. Its solubility characteristics and crystalline structure are carefully controlled during manufacturing to ensure optimal dissolution rates and bioavailability within these complex matrices. Shilpa Pharma provides Ambroxyl Hydrochloride with consistent physicochemical properties, which are critical for predictable formulation behavior.
Formulation scientists must consider the compatibility of Ambroxyl Hydrochloride with common excipients, including diluents, binders, disintegrants, and lubricants. Our technical team offers comprehensive data on excipient compatibility and stability profiles to assist clients in developing robust and stable finished products. The API’s processing notes, including its flowability and compressibility, are crucial for efficient tablet manufacturing processes, such as direct compression or granulation. Shilpa Pharma supports clients not only with high-quality API supply but also through our CDMO services, offering expert guidance in formulation development, process scale-up, and technology transfer, ensuring seamless integration into diverse manufacturing operations worldwide.
Beyond immediate-release formulations, Ambroxyl Hydrochloride also presents opportunities for integration into modified-release or combination products, where its controlled release can enhance therapeutic profiles or combine effectively with other active ingredients like bronchodilators or antibiotics. Such specialized formulations demand precise control over API characteristics and manufacturing processes. As a trusted Ambroxyl Hydrochloride supplier from India, Shilpa Pharma is equipped to provide custom synthesis and contract manufacturing solutions to meet these specific requirements, supporting pharmaceutical innovators from research quantities to full commercial scale. Our expertise ensures that even the most complex formulation challenges can be addressed with scientific rigor and manufacturing excellence.
Ensuring the industrial and regulatory safety of Ambroxyl Hydrochloride is paramount for its handling, storage, and pharmaceutical application. Shilpa Pharma’s product is supplied with detailed specifications for recommended storage conditions, typically requiring storage in a cool, dry place at controlled room temperature (e.g., 15-30°C), protected from direct light and excessive humidity. These conditions are critical to preserve the API’s chemical integrity, prevent degradation, and maintain its specified purity profile over its designated shelf life and retest period, which are clearly outlined in the Certificate of Analysis (CoA).
Packaging requirements for Ambroxyl Hydrochloride involve robust, inert containers, often double-bagged in polyethylene liners and sealed in fiber drums, to prevent contamination and moisture ingress. For personnel handling, adherence to Good Manufacturing Practices (GMP) is mandatory, including the use of appropriate Personal Protective Equipment (PPE) such as dust masks or respirators, safety glasses, gloves, and protective clothing. Adequate local exhaust ventilation or general room ventilation should be employed in processing areas to minimize exposure to airborne particulates. Known incompatibilities or stability-sensitive conditions, such as strong oxidizing agents or extreme pH environments, are thoroughly documented in the Safety Data Sheet (SDS) provided by Shilpa Pharma.
From a regulatory standpoint, Ambroxyl Hydrochloride is assessed for compliance with international guidelines, including ICH Q3D for elemental impurities, where applicable, ensuring that trace metal levels are within acceptable limits. Shilpa Pharma, a leading Ambroxyl Hydrochloride exporter India, provides comprehensive quality documentation for every batch, including the Certificate of Conformance, detailed impurity profiling, and residual solvent analysis, all performed using validated analytical methods. This meticulous documentation package supports our clients’ regulatory submissions globally and assures industrial manufacturing personnel of the API’s consistent quality and safety for handling within a controlled environment.
The commercial pricing of pharmaceutical APIs like Ambroxyl Hydrochloride is influenced by a multifaceted array of factors, extending beyond mere production costs. Key drivers include the purity specification required by the client, the batch size ordered – with economies of scale often favoring larger volumes – and the comprehensive documentation requirements, such as US-DMF, CEP/EDMF, or specific country-level regulatory dossiers. The origin of the supply chain, the volatility of raw material costs, and global currency exchange rates also significantly impact final pricing. Shilpa Pharma transparently addresses these variables to provide competitive and stable pricing structures.
Indian GMP-certified manufacturers, including Shilpa Pharma, offer a distinct advantage in the global API market. Our operational efficiencies, access to a skilled scientific workforce, and well-established infrastructure allow us to provide high-quality Ambroxyl Hydrochloride at competitive price points without compromising on stringent quality standards. This cost-effectiveness is a critical factor for generic drug companies and pharmaceutical manufacturers seeking to optimize their production expenses while maintaining product integrity and regulatory compliance. Our ISO-certified facilities and adherence to global GMP guidelines ensure that quality is never sacrificed for affordability.
Sourcing Ambroxyl Hydrochloride from a vertically integrated manufacturer like Shilpa Pharma offers considerable benefits over engaging with trading intermediaries. Vertical integration provides greater control over the entire production process, from raw material sourcing to final API synthesis, leading to enhanced quality assurance, supply chain reliability, and often, more favorable pricing due to reduced overheads and markups. Shilpa Pharma accommodates all order sizes, from small research quantities for initial R&D to full commercial volumes, with flexible Minimum Order Quantities (MOQs) tailored to client needs. Furthermore, establishing long-term supply agreements with Shilpa Pharma, one of the prominent Ambroxyl Hydrochloride manufacturers in India, offers clients significant advantages in terms of cost stability, guaranteed supply, and predictable budgeting. To receive a tailored quotation or discuss supply requirements, buyers are encouraged to contact us directly.
Choosing Shilpa Pharma as your partner for Ambroxyl Hydrochloride signifies a strategic decision rooted in reliability, quality, and comprehensive support. Our manufacturing infrastructure in India is not merely GMP-certified but consistently audited to meet the highest international standards, ensuring that every batch of Ambroxyl Hydrochloride adheres to strict quality benchmarks. This commitment to manufacturing excellence is critical for pharmaceutical manufacturers, generic companies, CDMOs, and research organizations worldwide who demand uncompromised product integrity for their formulations.
Our regulatory affairs expertise is a significant differentiator. Shilpa Pharma provides robust regulatory dossiers, including US-DMF, CEP/EDMF, and Certificate of Pharmaceutical Product (COPP), facilitating seamless market entry and product registration in regulated markets across North America, Europe, Asia-Pacific, Latin America, the Middle East, and Africa. Our state-of-the-art analytical capabilities, encompassing advanced techniques such as High-Performance Liquid Chromatography (HPLC), Gas Chromatography (GC), Karl Fischer titration, and particle size analysis, ensure meticulous characterization and quality control of Ambroxyl Hydrochloride. This comprehensive analytical support guarantees product consistency and compliance with pharmacopoeial specifications.
Beyond API supply, Shilpa Pharma offers extensive about Shilpa Pharma and CDMO services, ranging from custom synthesis and process development to scale-up and technology transfer. This integrated approach allows us to support clients at every stage of their product lifecycle, from early-stage research to commercial manufacturing. Our dedicated technical support team provides expert assistance for formulation queries, ensuring optimal integration of Ambroxyl Hydrochloride into various dosage forms. With a globally auditable supply chain and a straightforward procurement process from initial inquiry to final delivery, Shilpa Pharma stands as a trusted and efficient Ambroxyl Hydrochloride manufacturer and exporter, committed to fostering long-term partnerships built on trust and scientific rigor.
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Please Note: We partner exclusively with pharmaceutical manufacturers, biotech companies, and international trading firms. Minimum order quantities apply*
