Details | Specifications |
|---|---|
CAS Number |
165800-06-6 |
Molecular Formula |
C5H10N2O7P2.H2O |
Molecular Weight |
290.1 |
Synonyms |
(1-Hydroxy-2-imidazol-1-ylethylidene) diphosphonic acid, monohydrate2. |
Chemical Name |
(1-Hydroxy-2-imidazol-1-ylethylidene) diphosphonic acid, monohydrate1 |
Grade |
USP/ Ph.Eur./IH |
Polymorph |
Form-I |
GTI and NI |
Risk assessment available |
DMF Availability |
Available |
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.
Zoledronic Acid, chemically identified as (1-Hydroxy-2-imidazol-1-ylethylidene) diphosphonic acid, monohydrate, with CAS Number 165800-06-6, stands as a critical active pharmaceutical ingredient within the bisphosphonate class. This nitrogen-containing bisphosphonate is recognized for its potent inhibitory action on osteoclastic bone resorption, a mechanism primarily mediated through its interaction with farnesyl pyrophosphate synthase within the mevalonate pathway. Its molecular weight is precisely 290.1, reflecting its specific chemical structure which includes two phosphonate groups essential for its affinity to bone mineral. The API finds extensive application in the pharmaceutical industry for managing conditions characterized by excessive bone turnover, making it strategically important for manufacturers developing therapies in this area. Shilpa Pharma, as one of the prominent Zoledronic Acid manufacturers in India, ensures that this API adheres to the stringent quality specifications of USP, Ph.Eur., and IH pharmacopoeial standards, guaranteeing its suitability for global pharmaceutical applications. Our commitment to maintaining these high standards across our range of pharmaceutical APIs underscores our dedication to supporting the development of safe and effective medicines worldwide. The precise synthesis and purification processes employed by Shilpa Pharma ensure that the Zoledronic Acid API consistently meets the required purity profile, enabling its use in various finished dosage forms across diverse therapeutic markets.
Zoledronic Acid is predominantly formulated into parenteral dosage forms, primarily as intravenous infusions, owing to its physicochemical properties and therapeutic targets. Its solubility characteristics necessitate careful consideration during formulation development, typically requiring an aqueous medium for reconstitution or direct infusion. Given its bisphosphonate nature, excipient compatibility is a critical factor, as certain cations can complex with the diphosphonate moiety, potentially affecting bioavailability or stability. Formulation scientists must meticulously evaluate pH, tonicity, and buffer systems to ensure optimal API stability and physiological compatibility for injectable preparations. While primarily administered parenterally, the principles of its chemical behavior are universally applied in any development. Shilpa Pharma, a leading Zoledronic Acid supplier from India, offers comprehensive support through our CDMO services, assisting clients with formulation development, process optimization, and scale-up activities. Our expertise extends to addressing specific challenges related to API handling, dissolution kinetics, and ensuring batch-to-batch consistency for both research quantities and full commercial volumes. We provide critical insights into processing notes for sterile manufacturing, including considerations for filtration and lyophilization cycles, to achieve a stable and efficacious final product. Our collaborative approach ensures that clients can successfully navigate the complexities of developing Zoledronic Acid-containing drug products, from initial concept to commercial realization, with robust technology transfer packages.
The safe handling and storage of Zoledronic Acid API are paramount to preserving its quality and ensuring personnel safety within industrial manufacturing settings. This API should be stored in tightly sealed containers, protected from light and moisture, typically at controlled room temperature (e.g., 20-25°C), to maintain its chemical integrity over its specified shelf life and retest period. Packaging requirements involve inert materials that do not react with the diphosphonic acid, often high-density polyethylene (HDPE) bottles or double-bagged in clean, static-dissipative liners within drums, to prevent degradation and contamination. Personnel handling Zoledronic Acid should adhere to strict guidelines, including the use of appropriate Personal Protective Equipment (PPE) such as gloves, eye protection, and respiratory masks, especially during weighing and transfer operations where dust generation might occur. Adequate local exhaust ventilation or containment systems are essential in processing areas. Shilpa Pharma, a reliable Zoledronic Acid exporter India, provides comprehensive documentation including a Certificate of Analysis (CoA), Certificate of Conformance (CoC), and Safety Data Sheet (SDS) with every shipment. Our quality control processes include rigorous impurity profiling, residual solvent analysis, and elemental impurity testing in accordance with ICH Q3D guidelines, ensuring that our Zoledronic Acid meets global regulatory classifications and safety standards. Known incompatibilities typically involve polyvalent metal ions, which can lead to precipitation, thus requiring careful consideration during formulation and storage.
The pricing structure for pharmaceutical APIs like Zoledronic Acid is influenced by a confluence of factors, including the purity specification, the complexity of the synthetic route, batch size requirements, and the necessity for specific regulatory documentation such as US-DMFs or CEPs. Raw material costs, which can fluctuate due to global supply and demand dynamics, and currency exchange rates also play a significant role in determining the final price. Indian GMP manufacturers, such as Shilpa Pharma, are uniquely positioned to offer highly competitive pricing for Zoledronic Acid without compromising on quality or regulatory compliance. This advantage stems from integrated manufacturing capabilities, optimized process efficiencies, and access to a skilled scientific workforce. Sourcing Zoledronic Acid from a vertically integrated manufacturer like Shilpa Pharma offers distinct benefits over intermediaries, providing greater transparency in the supply chain, enhanced quality control at every stage of production, and improved cost-effectiveness due to reduced markups and streamlined logistics. We accommodate all order sizes, from small research quantities essential for early-stage development to large commercial volumes, offering flexible Minimum Order Quantities (MOQs) to meet diverse client needs. Establishing long-term supply agreements with Shilpa Pharma provides pharmaceutical buyers with predictable pricing, assured supply chain stability, and a reliable partnership. To receive a tailored quotation or discuss supply requirements, buyers are encouraged to contact us directly.
Choosing Shilpa Pharma as your partner for Zoledronic Acid API provides a distinct advantage for pharmaceutical manufacturers, generic drug companies, CDMOs, and research organizations across the globe. Our manufacturing infrastructure is meticulously designed and operated under strict GMP guidelines, holding both ISO and GMP certifications, ensuring the highest standards of quality and regulatory compliance. We possess comprehensive regulatory dossier capabilities, including readily available US-DMFs, CEP/EDMFs, and Certificates of Pharmaceutical Product (COPP), facilitating expedited drug product approvals in regulated markets such as North America and Europe, as well as emerging markets across Asia-Pacific, Latin America, the Middle East, and Africa. Our state-of-the-art analytical capabilities, featuring advanced instruments like HPLC, GC, Karl Fischer titrators, and particle size analyzers, guarantee the precise characterization and consistent quality of every batch of Zoledronic Acid. Beyond API supply, our extensive about Shilpa Pharma section details our CDMO services, ranging from custom synthesis of complex intermediates to process scale-up and technology transfer, offering end-to-end support for your development pipeline. With decades of worldwide export experience, we ensure a straightforward and auditable supply chain, from inquiry to timely delivery, supported by a dedicated technical team ready to address any formulation queries or specific project requirements. Shilpa Pharma stands out among Zoledronic Acid manufacturers in India for its unwavering commitment to quality, regulatory excellence, and client-centric service.
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Please Note: We partner exclusively with pharmaceutical manufacturers, biotech companies, and international trading firms. Minimum order quantities apply*
