GMP-Grade Sodium 4-Aminohippurate (PAH) 2g/10ml for Auxiliary Medicinal Product (AxMP) Use
Basic Pharma can manufacture Auxiliary Medicinal Products under strict Good Manufacturing Practice (GMP) guidelines. For example, the diagnostic agent Sodium 4-Aminohippurate (PAH) 2g/10ml is specifically designed for use as an Auxiliary Medicinal Product (AxMP), serving as a vital component in medical and research protocols requiring precise kidney function assessment.
How PAH Works in Kidney Function Assessment
Sodium 4-Aminohippurate (also known as aminohippurate sodium or PAH) is a synthetic compound widely used to measure effective renal plasma flow (ERPF). When administered intravenously, PAH is cleared from the blood by two main kidney processes:
- Glomerular Filtration: A small portion of PAH is filtered from the blood by the glomeruli.
- Active Tubular Secretion: The majority of PAH not filtered is actively transported from the bloodstream into the urine-forming tubules by specialized proteins called Organic Anion Transporters (OATs), primarily in the proximal tubules. This process is highly efficient.
Because of this efficient clearance, almost all PAH is removed from the plasma during a single pass through healthy kidneys (typically 90-92% extraction). This means the amount of PAH excreted in the urine accurately reflects the volume of plasma flowing through the functional kidney tissue. By measuring PAH concentrations in plasma and urine, along with urine flow rate, clinicians and researchers can precisely calculate ERPF. This quantitative measurement is crucial for diagnosing and monitoring kidney diseases, assessing kidney reserve, and optimizing drug dosages for patients with impaired renal function.
Utility of PAH in Clinical Trials
The precise and reliable measurement of renal plasma flow using PAH is invaluable in clinical trials. In drug development, changes in kidney function are often critical endpoints or safety markers. PAH clearance provides a sensitive method to:
- Assess Nephrotoxicity: It helps in the early detection and quantification of drug-induced kidney damage, assisting in safety evaluations during clinical trials.
- Evaluate Drug Efficacy: For treatments targeting kidney conditions, PAH clearance can directly measure the therapy’s impact on kidney hemodynamics and function.
- Characterize Pharmacokinetics: PAH helps understand how drugs are cleared by the kidneys, particularly the role of tubular secretion, which is vital for drug-drug interaction studies and precise dosing.
Its well-established physiological basis and reliability make PAH a robust tool for objective kidney function assessment, enhancing the scientific rigor and safety profiling in clinical investigations.
Basic Pharma's Commitment to Quality
The accuracy of renal function measurements relies heavily on the purity, concentration, and sterility of the PAH used. Basic Pharma’s manufacturing of Sodium 4-Aminohippurate 2g/10ml strictly adheres to GMP regulations. This ensures batch-to-batch consistency and complete traceability through rigorous quality control at every stage. Our product is manufactured in controlled environments and undergoes thorough sterilization, meeting the highest standards for injectable solutions and minimizing contamination risks. As an AxMP, PAH is produced and documented specifically for this classification, allowing researchers and clinicians to integrate it confidently into their protocols while meeting regulatory requirements.
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