Details | Specifications |
|---|---|
CAS Number |
119413-54-6 |
Molecular Formula |
C23H24ClN3O5 |
Molecular Weight |
457.9 g/mol |
Synonyms |
9-[(Dimethylamino) methyl]-10-hydroxy-(20S)-camptothecin. HCl |
Chemical Name |
(S)-10-((dimethylamino)methyl)-4-ethyl-4,9-dihydroxy-1H-pyrano[3',4':6,7]indolizino[1,2-b]quinoline-3,14(4H,12H)-dione hydrochloride |
Grade |
In-house |
Polymorph |
NA |
GTI and NI |
Risk assessment available |
DMF Availability |
NA |
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.
Topotecan Hydrochloride, a pivotal active pharmaceutical ingredient (API) with CAS number 119413-54-6, represents a crucial component in contemporary oncology therapeutics. Chemically designated as (S)-10-((dimethylamino)methyl)-4-ethyl-4,9-dihydroxy-1H-pyrano[3′,4′:6,7]indolizino[1,2-b]quinoline-3,14(4H,12H)-dione hydrochloride, this compound is a semi-synthetic derivative of camptothecin, belonging to the quinoline alkaloid class. Its molecular structure, characterized by the indolo[3,2-b]quinoline core and specific chiral centers, is meticulously engineered to achieve its pharmacological effect. Topotecan Hydrochloride functions as a topoisomerase I inhibitor, specifically targeting and stabilizing the covalent complex between topoisomerase I and DNA. This stabilization prevents DNA religation, leading to DNA strand breaks during replication and transcription, ultimately inducing apoptosis in rapidly dividing cells.
As a key API, Topotecan Hydrochloride holds significant strategic importance for pharmaceutical manufacturers globally, particularly those developing chemotherapeutic agents. Shilpa Pharma is recognized among the prominent Topotecan Hydrochloride manufacturers in India, providing high-purity material essential for the synthesis of vital anti-cancer medications. Our in-house grade API is manufactured under stringent GMP conditions, ensuring compliance with global regulatory expectations. We are committed to supplying Topotecan Hydrochloride that meets rigorous quality parameters, supporting the development and commercialization of life-saving drugs. Our comprehensive portfolio of pharmaceutical APIs reflects our dedication to advancing global health.
The therapeutic utility of Topotecan Hydrochloride is well-established in the treatment regimens for various solid tumors. Its precise mechanism of action makes it an indispensable agent in the arsenal against certain malignancies, driving consistent demand across regulated markets. Shilpa Pharma’s manufacturing processes are designed to yield an API with optimal physiochemical properties, critical for its subsequent formulation into drug products. Our expertise in complex organic synthesis and purification ensures the consistent delivery of a high-quality product, enabling our clients to meet their stringent product specifications and regulatory filing requirements, including the provision of comprehensive dossiers such as US-DMF, CEP/EDMF, and COPP.
Topotecan Hydrochloride is primarily formulated into parenteral dosage forms, specifically solutions for intravenous infusion, due to its therapeutic application in oncology. Its physicochemical properties, including solubility characteristics and stability in aqueous environments, are critical considerations during formulation development. The hydrochloride salt form enhances its aqueous solubility, which is essential for preparing sterile injectable solutions. Formulation scientists must carefully consider pH control, isotonicity, and the selection of appropriate excipients to ensure the API’s stability, bioavailability, and patient tolerability for intravenous administration. Shilpa Pharma provides comprehensive technical support to clients navigating these complex formulation challenges.
Beyond standard injectable formulations, the unique chemical profile of Topotecan Hydrochloride may also present opportunities for advanced drug delivery systems, although its primary use remains in conventional intravenous preparations. Factors such as chemical stability, degradation pathways, and potential incompatibilities with common pharmaceutical excipients must be thoroughly investigated during pre-formulation and formulation studies. Shilpa Pharma’s expertise extends to supporting clients through these critical stages, offering CDMO services that encompass formulation development, process scale-up, and technology transfer. This ensures that our clients can efficiently transition from laboratory-scale development to commercial manufacturing, maintaining product integrity and efficacy.
When incorporating Topotecan Hydrochloride into drug products, careful attention must be paid to its specific characteristics. The API’s sensitivity to light and certain pH ranges necessitates controlled manufacturing environments and appropriate packaging. Our role as a reliable Topotecan Hydrochloride supplier from India includes providing detailed technical data and impurity profiles to aid formulators. We collaborate with pharmaceutical manufacturers to optimize their processes, from initial concept to commercial production. Our CDMO capabilities are particularly beneficial for projects requiring custom synthesis of specialized intermediates or for optimizing the API manufacturing process itself to meet specific client requirements or regulatory milestones.
The manufacturing of Topotecan Hydrochloride drug products involves aseptic processing techniques to maintain sterility, given its injectable application. Compatibility studies with various excipients, such as buffers, solubilizers, and antioxidants, are crucial to prevent degradation or interaction that could compromise the final product’s quality. Shilpa Pharma’s analytical team can provide insights into these aspects, drawing upon extensive experience with complex APIs. Our support helps ensure that the Topotecan Hydrochloride supplied integrates smoothly into existing or novel drug product manufacturing lines, facilitating efficient and compliant production for our global clientele across North America, Europe, Asia-Pacific, Latin America, the Middle East, and Africa.
Ensuring the industrial and regulatory safety of Topotecan Hydrochloride is paramount throughout its manufacturing, handling, and storage. As a potent cytotoxic agent, strict adherence to occupational health and safety protocols is mandatory for all personnel involved. Recommended storage conditions for Topotecan Hydrochloride API typically involve maintaining the material in a tightly sealed container, protected from light and moisture, at controlled room temperature (e.g., 20°C to 25°C), or as specified in the Certificate of Analysis (CoA). These conditions are critical to preserve the API’s chemical integrity, prevent degradation, and maintain its specified shelf life and retest period. Shilpa Pharma ensures that all packaging meets pharmacopoeial standards to safeguard product purity during transit and storage.
Personnel handling Topotecan Hydrochloride must utilize appropriate personal protective equipment (PPE), including chemical-resistant gloves, eye protection, and respiratory protection, especially during activities that could generate airborne particles. Operations should be conducted in well-ventilated areas or under engineering controls such as laminar flow hoods to minimize exposure. Known incompatibilities or stability-sensitive conditions, such as exposure to strong acids, bases, or oxidizing agents, must be meticulously avoided. Our detailed Safety Data Sheet (SDS) provides comprehensive information on hazard identification, safe handling practices, emergency procedures, and disposal considerations, serving as an indispensable resource for our clients and their operational teams. Shilpa Pharma, as a leading Topotecan Hydrochloride exporter India, prioritizes safety and regulatory compliance in every aspect of our operations.
From a regulatory standpoint, Topotecan Hydrochloride is subject to various international guidelines, including those pertaining to elemental impurities (ICH Q3D) and residual solvents. Shilpa Pharma conducts thorough impurity profiling and residual solvent analysis to ensure our API consistently meets these stringent requirements. We provide a comprehensive suite of quality documentation to support our clients’ regulatory submissions, including a detailed Certificate of Analysis (CoA), Certificate of Conformance (CoC), and full impurity profiles. Our manufacturing facilities are ISO-certified and GMP-compliant, undergoing regular audits to maintain the highest standards of quality and regulatory adherence. This commitment to quality assurance is a cornerstone of our operations, serving pharmaceutical manufacturers and research institutions globally.
The commercial pricing of pharmaceutical APIs like Topotecan Hydrochloride is influenced by a multitude of factors, reflecting the complexity and regulatory stringency of the pharmaceutical supply chain. Key drivers include the purity specification (e.g., in-house, USP, EP), the batch size required, and the extent of regulatory documentation provided, such as US-DMF or CEP/EDMF filings. Raw material costs, which can fluctuate based on global supply and demand dynamics, also play a significant role. Furthermore, the origin of the supply chain and prevailing currency exchange rates contribute to the final price structure, making procurement a strategic exercise for pharmaceutical manufacturers worldwide.
Indian GMP manufacturers, including Shilpa Pharma, are uniquely positioned to offer highly competitive pricing for high-quality APIs such as Topotecan Hydrochloride, without compromising on stringent quality standards. This competitive advantage stems from several factors: a well-developed local chemical industry, skilled scientific and technical talent, and efficient manufacturing processes that benefit from economies of scale. By sourcing from a vertically integrated manufacturer like Shilpa Pharma, clients gain the distinct advantage of a streamlined supply chain, reducing reliance on intermediaries and enhancing transparency. This direct relationship often translates into better cost control and more reliable supply compared to engaging with trading houses.
Shilpa Pharma is committed to accommodating all order sizes, from research quantities essential for early-stage development to full commercial volumes required for large-scale production. We understand that different clients have varying needs, and our flexible Minimum Order Quantities (MOQs) are designed to support this diversity. This flexibility is particularly beneficial for biotech firms and research institutions needing smaller quantities, as well as for generic drug companies requiring substantial commercial batches. Our ability to scale production efficiently ensures that clients can procure Topotecan Hydrochloride precisely as needed, optimizing their inventory management.
Establishing long-term supply agreements with Shilpa Pharma provides pharmaceutical buyers with significant benefits, including enhanced cost predictability and supply chain stability. These agreements help mitigate market volatility and ensure a consistent supply of critical APIs, which is crucial for maintaining uninterrupted drug manufacturing operations. As one of the dedicated Topotecan Hydrochloride manufacturers in India, Shilpa Pharma stands by its commitment to quality, regulatory compliance, and reliable global supply. Our goal is to forge enduring partnerships built on trust and mutual success. To receive a tailored quotation or discuss supply requirements, buyers are encouraged to contact us directly.
Pharmaceutical manufacturers, generic drug companies, CDMOs, and research organizations worldwide choose Shilpa Pharma as their preferred partner for Topotecan Hydrochloride due to our unwavering commitment to quality, regulatory excellence, and comprehensive support services. Our manufacturing infrastructure is ISO-certified and GMP-compliant, reflecting adherence to the highest international standards for pharmaceutical production. This ensures that every batch of Topotecan Hydrochloride we produce meets stringent purity, potency, and safety specifications, critical for its application in oncology therapeutics. Clients can confidently integrate our API into their drug products, knowing it originates from a facility that prioritizes compliance and quality at every stage.
A significant advantage of partnering with Shilpa Pharma is our robust regulatory dossier capability. We provide essential documentation such as US-DMF (Drug Master File), CEP/EDMF (Certificate of Suitability/European Drug Master File), and COPP (Certificate of Pharmaceutical Product), facilitating our clients’ regulatory submissions in markets across North America, Europe, Asia-Pacific, Latin America, the Middle East, and Africa. This comprehensive regulatory support significantly expedites the drug development and approval process for our partners. Our extensive worldwide export experience ensures efficient and compliant delivery of Topotecan Hydrochloride to any global destination, supported by an auditable supply chain that guarantees traceability and integrity from raw material to final product.
Shilpa Pharma offers more than just API manufacturing; our integrated CDMO services span from custom synthesis of complex intermediates to process scale-up and technology transfer. This end-to-end capability allows us to support clients at any phase of their drug development lifecycle, providing tailored solutions that accelerate their projects. Our dedicated technical support team, comprising experienced PhD chemists and formulation scientists, is readily available to address any formulation queries or technical challenges, ensuring optimal integration of Topotecan Hydrochloride into drug products. This collaborative approach underscores why so many global partners trust Shilpa Pharma, a premier Topotecan Hydrochloride manufacturer and exporter, for their critical API needs.
Our analytical capabilities are equally impressive, featuring state-of-the-art equipment for HPLC, GC, Karl Fischer analysis, and particle size analysis, ensuring precise characterization and quality control of our API. The straightforward procurement process, from initial inquiry to final delivery, is designed for efficiency and transparency, making Shilpa Pharma an ideal partner for consistent and reliable supply. To learn more about our commitment to excellence and our extensive capabilities, please visit our about Shilpa Pharma page.
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Please Note: We partner exclusively with pharmaceutical manufacturers, biotech companies, and international trading firms. Minimum order quantities apply*
