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Triamterene (CAS 396-01-0): Applications and Competitive Advantages in Manufacturing
Introduction
Triamterene (CAS 396-01-0), a potassium-sparing diuretic with the molecular formula C₁₂H₁₁N₇ and a molecular weight of 253.26 g/mol, is a critical therapeutic agent in managing edema, hypertension, and electrolyte imbalances. Recognized for its ability to inhibit epithelial sodium channels (ENaC) in the distal renal tubules, Triamterene reduces potassium excretion, making it invaluable for patients at risk of hypokalemia. Beyond its clinical applications, this compound is widely utilized in biochemical research, pharmaceutical intermediates, and analytical standards. This article explores the multifaceted applications of Triamterene and highlights the manufacturing excellence of leading producers, emphasizing their technological innovation, quality control, and market leadership.
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Chemical and Pharmacological Profile
Triamterene’s structure—comprising a 2,4,7-triamino-6-phenylpteridine backbone—enables selective ENaC blockade, altering sodium reabsorption and potassium retention. Key properties include:
- Mechanism of Action : Inhibits sodium influx in renal tubules, promoting diuresis without significant potassium loss.
- Pharmacokinetics : Rapid absorption with peak plasma concentrations within 2–4 hours; metabolized to sulfate conjugates and excreted renally.
- Synergistic Use : Often combined with thiazide diuretics (e.g., hydrochlorothiazide) to counteract hypokalemia in hypertension management.
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Therapeutic and Research Applications
1. Clinical Medicine
- Edema Management : Triamterene is a first-line therapy for congestive heart failure, liver cirrhosis, and nephrotic syndrome, reducing fluid retention while preserving potassium levels.
- Hypertension : Used adjunctively to mitigate electrolyte imbalances caused by other antihypertensive agents.
- Off-Label Uses : Investigated for conditions like lithium-induced polyuria and cystic fibrosis due to its ENaC modulation.
2. Biochemical Research
- Ion Channel Studies : Triamterene serves as a tool to investigate ENaC function and electrolyte homeostasis in renal physiology.
- Drug Delivery Systems : Research explores its encapsulation in cyclodextrins or lipid nanoparticles to enhance solubility and bioavailability.
3. Analytical Standards
Triamterene is employed in high-performance liquid chromatography (HPLC) and mass spectrometry (LC-MS) as a reference standard for drug quantification in pharmacokinetic studies.
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Manufacturing Excellence: Key Players and Competitive Advantages
1. Xi’an Qiyue Biotechnology Co., Ltd. (China)
- Scalability : Offers bulk production up to kilogram-scale with 99% purity, catering to both research and commercial pharmaceutical demands.
- Packaging Flexibility : Provides diverse packaging options (100 mg to 10 kg) to meet client-specific needs.
- Logistics : Utilizes cold-chain transportation for temperature-sensitive batches, ensuring global delivery integrity.
2. Wuhan Nuohui Pharmaceutical (China)
- GMP Compliance : Operates ISO-certified facilities with advanced synthesis capabilities, producing APIs that meet FDA and EMA standards.
- R&D Expertise : Employs a team of PhD and MSc researchers to innovate synthesis routes and impurity control protocols.
3. Santa Cruz Biotechnology (USA)
- Research-Grade Precision : Supplies Triamterene with ≥98% purity, validated via NMR and LC-MS, for non-clinical studies.
- Technical Support : Offers 24/7 customer service and detailed analytical certificates to academic and industrial researchers.
4. Adamas Life (via Tansoole Platform)
- High Purity : Delivers Triamterene at ≥98% purity, certified for research use, with rapid availability and competitive pricing (e.g., $200/25g).
- Regulatory Adherence : Complies with global safety standards, including hazard classification (UN 2811) and storage guidelines (-20°C).
5. Shijiazhuang Ruitian Biochemical Co., Ltd. (China)
- Cost Efficiency : Produces industrial-grade Triamterene intermediates at $25/kg, leveraging patented synthesis routes for high yield (>99%).
- Market Reach : Distributes globally, with a focus on pharmaceutical and veterinary markets.
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Quality Control and Regulatory Compliance
Leading manufacturers prioritize:
- Analytical Rigor : Techniques like HPLC, GC-MS, and NMR ensure batch consistency, with residual solvent levels <0.6%.
- Stability Testing : Validates shelf life (up to 12 months at 2–8°C) and light sensitivity management.
- Certifications : Adherence to ISO 9001, ICH Q7, and FDA 21 CFR Part 211 standards.