Tengfei Creation Center,55 Jiangjun Avenue, Jiangning District,Nanjing admin@sinochem-nanjing.com 3389378665@qq.com
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Canrenonum

    • Product Name Canrenonum
    • Alias Spironolactone
    • Einecs 211-579-1
    • Mininmum Order 1 g
    • Factory Site Tengfei Creation Center,55 Jiangjun Avenue, Jiangning District,Nanjing
    • Price Inquiry admin@sinochem-nanjing.com
    • Manufacturer Sinochem Nanjing Corporation
    • CONTACT NOW
    VTB
    Specifications

    HS Code

    579784

    generic_name Canrenone
    brand_name Canrenonum
    drug_class Aldosterone antagonist
    chemical_formula C22H28O3
    molecular_weight 340.46 g/mol
    route_of_administration Oral
    therapeutic_use Diuretic, antihypertensive
    ATC_code C03DA02
    half_life 16-18 hours
    legal_status Prescription only
    appearance White to off-white crystalline powder
    CAS_number 976-71-6

    As an accredited Canrenonum factory, we enforce strict quality protocols—every batch undergoes rigorous testing to ensure consistent efficacy and safety standards.

    Packing & Storage
    Packing Canrenonum is packaged in amber glass vials, each containing 50 mg powder for injection, sealed with a rubber stopper and aluminum cap.
    Shipping Canrenonum should be shipped in tightly sealed, labeled containers to prevent moisture and contamination. It must be transported as a non-hazardous chemical under standard conditions, avoiding extreme temperatures and direct sunlight. Ensure compliance with local regulations, and include safety data documentation with the shipment for proper handling and emergency response.
    Storage Canrenonum should be stored in a tightly closed container, protected from light and moisture, at room temperature (generally 15–25°C). It must be kept away from incompatible substances and out of reach of unauthorized personnel. Store in accordance with local regulations and manufacturer recommendations to ensure stability and prevent degradation. Avoid exposure to excessive heat or humidity.
    Application of Canrenonum

    Applications of Canrenonum in Industrial Manufacturing

    Canrenonum plays a critical role as a pharmaceutical intermediate and active substance in specialized chemical processing routes. As a dedicated manufacturer, we focus on distinct pharmaceutical and biotech application tracks where high-purity Canrenonum supports GMP-compliant synthesis and high-value product formulation. The following specific industrial sectors utilize Canrenonum for its pharmacological properties and synthetic value in tightly controlled environments.

    1. Antihypertensive Drug Production

    Leading pharmaceutical companies integrate Canrenonum as an API for oral antihypertensive drugs, particularly within the mineralocorticoid receptor antagonist class. Synthesis involves precise crystallization after hydrogenation and acetate removal, followed by micronization to achieve consistent dissolution profiles in tablet manufacturing. Stringent process validation ensures each production batch meets regulatory-defined impurity limits, and in-process controls monitor particle size for pressing and coating operations targeting extended release properties.

    Industry compliance standards

    • European Pharmacopoeia (Ph. Eur.) monograph for Canrenonum
    • Current Good Manufacturing Practice (cGMP), 21 CFR Parts 210/211
    • ICH Q3A/B guidelines for residual solvents and impurities
    • Chinese Pharmacopoeia ChP 2020 Edition

    Typical usage ratio

    • API loading of 25–100 mg per tablet, with final drug batch purity exceeding 99%
    • The ratio in bulk blending depends on tablet size and formulation requirements, adjusted during granulation based on analytical batch performance

    Downstream process integration

    • Introduced post-synthesis during API isolation
    • Micronized, batch-standardized, and blended with core excipients
    • Granulated and compressed after in-process QC
    • Encapsulated or film-coated before final packaging

    Final product types

    • Film-coated antihypertensive tablets
    • Oral suspensions for hospital use
    • Combination fixed-dose drug forms (e.g., with other cardiovascular APIs)

    2. Diuretic Injectable Preparations

    Hospitals and contract manufacturing organizations (CMOs) source sterile-grade Canrenonum for formulation into injectable diuretic preparations. Production involves sterilization-grade filtration, solution compounding under aseptic conditions, and strict endotoxin control. Process flow ensures powder and lyophilized injectable forms achieve defined potency standards, supporting rapid deployment in acute care and ICU settings for edema management.

    Industry compliance standards

    • European Pharmacopoeia parenteral standards
    • Good Manufacturing Practice for Sterile Drug Products (FDA 21 CFR 212)
    • ISO 14644-1 Cleanroom Classification for filling lines
    • USP Chapter <797> for compounding sterile preparations

    Typical usage ratio

    • API concentration typically at 25–50 mg/mL canrenone sodium solution
    • Adjustments based on patient dose requirements, reconstitution volume, and compounding protocol

    Downstream process integration

    • API dissolved, filtered via 0.22 μm for sterile formulation
    • Bulk solution prefilled into vials/ampoules, followed by terminal sterilization or aseptic lyophilization
    • Integrated with water for injection (WFI) systems
    • Batches subjected to lot release microbial and endotoxin testing

    Final product types

    • Sterile lyophilized vials for injection
    • Ready-to-use injectable ampoules
    • Emergency-use diuretic kits

    3. Biosimilar Mineralocorticoid Blocker Synthesis

    Biotech manufacturers and biosimilar-focused pharmaceutical plants employ Canrenonum as a key reference intermediate for process validation and eventual biosimilar launch. This application requires close matching to reference listed drugs in chromatographic purity, stereochemistry, and impurity profile. The intermediate serves as a spiking control in biosimilar assay development and as a substrate in biotransformation steps involving microbial or enzymatic modifications.

    Industry compliance standards

    • EMA guidelines on Similar Biological Medicinal Products
    • ICH Q6B Specifications: Test Procedures and Acceptance Criteria
    • ISO 17025 Laboratory Accreditation for analytical assays
    • GMP for Investigational Medicinal Products (EU GMP Annex 13)

    Typical usage ratio

    • Spiking concentration in analytical method validation: precise microgram-to-milligram per mL levels, defined by bioanalytical protocols
    • Substrate load for biotransformation: 1–5 g/L depending on scale and target yield

    Downstream process integration

    • Dosed during microbial fermentation or enzymatic conversion steps
    • Integrated as control in HPLC and LC-MS/MS calibration curves
    • Sampled throughout downstream purification and QC for biosimilarity assessment
    • Final isolation through preparative chromatography

    Final product types

    • Biosimilar injectable formulations matching branded reference drugs
    • Comparative R&D material for global regulatory submission
    • Preclinical and clinical biosimilar test batches

    4. API Reference and Analytical Standards

    Reference laboratories and regulated pharmaceutical QC facilities rely on ultra-pure Canrenonum as a validated analytical standard. Accurate quantification and identity confirmation in both process and finished dosage forms require traceable, lot-characterized standards with comprehensive CoA and impurity data. These standards calibrate HPLC, LC-MS, and GC methods as part of regulatory compliance and process validation workflows.

    Industry compliance standards

    • USP Reference Standards protocols
    • ISO/IEC 17025 laboratory quality system
    • ICH Q2 Validation of Analytical Procedures
    • FDA Data Integrity Guidance

    Typical usage ratio

    • 0.1–10 mg per calibration batch, depending on analytical method and sample mass
    • Prepared in high-purity solvents with documented weighing and dilution traceability

    Downstream process integration

    • Direct use in routine batch release testing
    • Control standard in method transfer and inter-laboratory comparisons
    • Supports forced degradation studies as API identifier
    • Certifies equipment calibration before regulatory audits

    Final product types

    • Certified reference material (CRM) kits
    • Primary and secondary analytical standards
    • Quality control assay panels
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    Certification & Compliance
    More Introduction

    Canrenonum: Introducing a Quality Product Directly from Our Facility

    At our manufacturing plant, years of hands-on work with steroidal pharmaceuticals have shaped our approach to producing Canrenonum. We have built our expertise around precision, experience, and real-world insights. Among all the products we manufacture, few call for tighter process control or better understanding of ingredient behavior than Canrenonum. Each batch we bring to market reflects not just the technical specifications, but also the lessons learned from scaling up the process, managing supply fluctuations, and supporting customers in both industry and research fields.

    Understanding Canrenonum: What Sets It Apart

    Canrenonum, known in scientific settings as canrenone, stands out in the world of potassium-sparing diuretics. The molecular structure, C22H28O3, carries a long history in medical applications—especially in treating fluid retention issues that patients experience due to problems like heart failure or liver cirrhosis. Canrenonum acts as the active metabolite of spironolactone, but with a cleaner profile due to the absence of sulfur-containing groups, which often lead to unwanted hormonal side effects in some patients.

    We have seen firsthand how medical researchers, as well as pharmaceutical formulation teams, rely on consistent quality. Customers who order directly from us often express relief at the difference they experience compared to material bought through indirect channels. This is not just about purity numbers; it's about consistency in powder flow, reliability of solubility, and, crucially, predictability in synthesizing further intermediates or finished dosage forms. Reproducible quality goes hand-in-hand with safety and therapeutic predictability for end-users.

    Our Production Method: Control from Start to Finish

    Our Canrenonum follows a route that leverages both batch and continuous processing, depending on the volume ordered and the necessary specification. By keeping control of both precursor purification and final crystallization in-house, our technicians have the flexibility to respond quickly to changes in the feedstock supply and to client demands for specific particle sizes or solvent residues. We have invested in closed-system drying and custom-milled filtration lines. This means we avoid contamination by airborne particulates—a risk that sometimes gets overlooked until it shows up as batch-to-batch variability downstream.

    Over the years, we have learned the value of disciplined cleanliness—not only in terms of GMP compliance, but also in how it affects every downstream stage. With every kilogram produced, our in-process controls verify identity and impurity levels rigorously, using modern HPLC and NMR methods. Our experience shows that this step cannot be skipped or minimized if we want to guarantee the safety of end products. Even minor impurities, like 7α-thiomethylspirolactones, can be troublesome in the later stages of formulation and are systematically removed in our facility.

    Application in Industry and Clinical Research

    Doctors and clinical researchers turn to Canrenonum due to its precision in blocking mineralocorticoid receptors without crossing into strong antiandrogenic or estrogenic side effects. Unlike spironolactone, Canrenonum does not convert into several active metabolites with mixed hormonal properties. This gives it a distinct edge for long-term studies where reproducibility of action is critical.

    We often get asked about the difference between sourcing directly from a manufacturer and purchasing generic pharmaceutical intermediates repackaged by a third party. The truth is clear in the results. Whether running confirmatory assays or setting up pilot runs for new therapies, predictability saves both time and cost. In both academic and industry settings, reproducibility directly depends on a controlled supply chain. Institutions that collaborate with us bring up the ease they have preparing standard solutions, calibrating analytical equipment, or validating their methods. What starts as a pure, well-characterized powder on our end becomes a foundation for advanced pharmacological research, drug release studies, and even in vitro tissue investigations.

    Specification and Model Offerings

    Over a decade of constant feedback from customers shaped the way we set specifications for Canrenonum. Our standard commercial grade features purity upwards of 99.5% (by HPLC), with individual documented impurity thresholds conforming to international pharmacopoeias. Moisture content sits well below 0.5%, and every batch passes strict checks for heavy metal traces and residual solvents. These numbers only mean something if they hold up, batch after batch. For research groups and clinical trial sponsors who need extra-tight control, we produce a higher analysis grade. These lots undergo additional rounds of recrystallization and conditioning and come with a more extensive certificate of analysis.

    We realize that not all end users need the same format. That’s why our team prepares Canrenonum in both fine crystalline powder and compacted pellet forms. Our powder workhorse meets the demands of those who need to blend or dissolve rapidly—ideal for compounding pharmacies or laboratories running repeated solubility or bioavailability tests. The pelleted variant offers the advantage of reduced dust and easier portioning, which makes it a better fit for packaging lines at contract manufacturers. From our viewpoint, this reduces product loss, makes dosing more precise, and keeps cleanup and batch changes running smoothly.

    Why Manufacturing Quality Directly Affects Clinical Outcomes

    There’s a direct link between how we make Canrenonum and the reliability of every research result or therapy it supports. On more than a few occasions, partners have brought us samples bought from brokers, only to find levels of uncharacterized impurities or inconsistent moisture. We understand the downstream impact. Even sub-ppm amounts of certain impurities can alter biological assay results, and moisture variability can affect compounding and shelf-life. Our team’s diligence in controlling these parameters comes from real-world requests and urgent troubleshooting calls from labs facing unexpected anomalies—not just regulatory mandates.

    With Canrenonum, pharmacologists get the benefit of a clean profile, free from significant androgenic or estrogenic activity, letting them probe aldosterone receptor pathways without confounding effects. Drug developers value material that behaves the same across every pilot lot—whether in dissolved form in a glass vial or tableted at scale for blinded clinical trial runs. Over time, we’ve built up both the capacity and the technical expertise to support uses that range from hospital pharmacy preparations to novel mechanism-of-action studies in biotech startups.

    Comparison with Other Diuretics and Steroidal Intermediates

    Many clients come to us comparing Canrenonum directly with spironolactone, eplerenone, or even non-steroidal diuretics like amiloride. While all address mineralocorticoid excess, Canrenonum has a unique steroid skeleton that translates into high binding selectivity but noticeably fewer side effects for most patients. For production chemists or formulation scientists, Canrenonum’s absence of sulfur groups and the way our process preserves the lactone ring structure reduces the risks linked with impurity carryover. This is not just a matter of pharmacology, but of process chemistry and industrial reliability.

    Those who have attempted to synthesize analogs based on bulk materials sourced via indirect or poorly documented channels often run into trouble with undesired side reactions or instability during subsequent steps. Since our process starts with carefully selected raw material and runs under constant analytical control, we can assure not just purity on paper, but a stability profile that stands up through storage and distribution.

    Regulatory Experience and Real-World Inspections

    No manufacturer thrives in the pharmaceutical space without surviving thorough inspections. We’ve hosted audit teams from global clients and regulatory bodies alike. One key lesson stands out: every shortcut, every source of uncharacterized residue, every overlooked cleaning step will eventually come to light. We’ve designed our SOPs and invested in staff training to avoid surprises. Batch traceability and document transparency let customers and auditors alike follow every gram from raw material acceptance to finished packaging—as robust as any chain of custody in the industry.

    Real transparency matters, especially for customers planning registration batches or in-process validations. We share not only our certificates of analysis but also detailed manufacturing and control records when needed, including full impurity profiles. Feedback from GMP customers has been clear—dealing direct with the producer helps unravel questions rapidly, solves discrepancies without a game of telephone between brokers, and supports successful submissions in regulated regions. It eliminates the uncertainty that creeps in from mysterious logistics chains and “white-labeled” goods.

    Environmental and Process Safety Commitments

    Handling and synthesizing steroid intermediates responsibly requires a commitment that runs deeper than compliance. Over years of operation, we have invested in on-site solvent recovery and operate with minimized water use. Our facilities run closed-loop filtration systems and inert gas blanketing. As a result, not only do we lower environmental impact, but we also protect the batch-to-batch consistency clients rely on. This dual focus reflects what we learn each time regulators update standards or a partner asks for a detailed life-cycle analysis.

    Operator safety shapes every step of our process. With potent compounds like Canrenonum, small amounts of product escaping into workrooms can present real risks. Our team has built effective air-handling, personal protective equipment procedures, and continuous monitor logging to ensure both product and people stay protected, every shift. In the years since implementing these changes, we’ve seen measurable improvements, both in operational uptime and in worker health metrics.

    Research Support, Problem Solving, and Collaborative Development

    Customers often come with challenges—sometimes out of regulatory complexity, and sometimes out of research needs. We pride ourselves on speaking the language of development chemists and analytical scientists, not just procurement officers. That means understanding the root issue when a researcher needs extra-low endotoxin levels or auxiliary analytical support for new polymorph discovery.

    Our history includes partnering on projects that push the boundaries of known chemistry and therapeutics. For example, clients developing topical preparations, osmotic pump formulations, or animal model studies bring unique requirements. We assist with documentation, supply custom batches, and share insights on solubility, compatibility, and shelf-life hurdles. This level of collaboration emerges from real experience—the everyday troubleshooting that goes into scaling a process or launching a first-in-human study.

    We do not just hand off a drum or carton and walk away. We believe in standing by the performance of our Canrenonum at every application stage. This philosophy shows up in the longevity of our partnerships, from academic departments running decade-long trials to pharmaceutical companies ramping up for global launches.

    Continuous Improvement: Learning from Every Batch

    The story of our Canrenonum production is one of daily lessons and steady progress. Any manufacturer who claims total infallibility is not being candid. As processes evolve, supply chains stretch, and new technologies emerge, we adapt by gathering detailed performance data and listening to our partners’ feedback. Over time, we’ve upgraded crystallization methods, added inline analytical checks, and rewritten standard operating procedures to minimize real-world risks like cross-contamination or unexpected crystal habits.

    Perhaps more than anything, our long-term involvement in the direct production of Canrenonum has taught us that quality arises from an ongoing dialog between chemists, operators, regulators, and users. We embrace new requests—whether that means exploring new solubilizers for challenging formulations or switching from multi-tonne batch reactors to agile, single-use setups for highly specialized orders. Each iteration adds a new piece of knowledge to our collective experience.

    Why It Matters to Work Directly with the Producer

    Over years of operation, we have encountered customers who arrived after trying to resolve inconsistent assay results or unexplained process failures with intermediaries whose supply chain stretched across multiple borders. There is no shortcut to accountability. Direct relationships with the actual manufacturer open doors for responsive troubleshooting, flexible customization, and above all, shared understanding of the practicalities of chemical handling at scale.

    When a delivery faces delay due to real-world logistics or a specification direction changes mid-project, our operations team can advise, adjust schedules, and even retool production priorities without waiting for approvals to percolate through layers of resellers. This immediacy helps clients save on time, cost, and uncertainty—vital in high-stakes industrial or clinical research programs.

    Moving Forward: Supporting Partnership and Transparency

    Each kilo of Canrenonum shipped from our facility represents more than a finished product. It embodies a commitment to the practical realities of manufactured pharmaceuticals—predictable supply, rigorous analysis, and the capacity to adapt as industries and research needs shift. Working directly with the manufacturer brings clarity and trust that indirect channels cannot provide.

    By focusing on the essentials—clean chemistry, process control, transparency, and continuous improvement—we offer not just a chemical, but a partnership. Teams who use our Canrenonum know they have a producer who values open communication, stands behind the material, and invests in learning from every shipment and every feedback call.

    This approach has allowed us to build strong relationships with customers worldwide, from start-up biotech firms to large, established pharmaceutical companies and academic institutes. We welcome informed questions, share data openly, and support new applications as they arise.

    Canrenonum serves as a clear example of how careful, experienced manufacturing directly benefits those developing, testing, and ultimately relying on advanced pharmaceutical compounds. Our commitment is long-term, rooted in technical skill and a willingness to keep learning from the people who use what we make. The value of Canrenonum grows not only from its chemical properties, but from the experience, transparency, and real-world problem-solving that only a direct manufacturer can offer.