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Pharmaceutical-grade sodium bicarbonate meeting strict USP/EP monograph requirements for hemodialysis applications.
Ultra-low levels of heavy metals (e.g., lead, arsenic) and microbial contaminants, ensuring patient safety in extracorporeal blood treatment.
Consistent particle size distribution optimized for precise dissolution and stable buffer performance in dialysate concentrates.
High chemical purity (>99.9% NaHCO₃) with minimal chloride and sulfate impurities to prevent membrane fouling and electrolyte imbalance.
Manufactured under ISO 9001 and ISO 13485-certified quality management systems with full traceability and batch documentation.
Primary buffering agent in sterile, ready-to-use hemodialysis concentrate solutions.
Key component in central dialysis fluid delivery systems (CFDS) for hospital-based renal care units.
Raw material for compounding bicarbonate-based dialysate in pharmacy-prepared or automated admixture systems.
Formulation ingredient in portable and home hemodialysis fluid cartridges requiring high-purity, low-endotoxin excipients.
Reference standard and process material in pharmaceutical development and validation of dialysate manufacturing processes.
| Chemical Type | Sodium bicarbonate (NaHCO₃) |
| Product Form | Free-flowing white crystalline powder |
| Appearance | White, odorless, fine crystalline solid |
| Primary Applications | Hemodialysis concentrate formulation, pharmaceutical buffer system |
| Key Features | USP/EP compliant, low endotoxin, low heavy metals, high assay purity |
| Benefits | Ensures dialysate stability, minimizes patient risk, supports regulatory filing and GMP compliance |
| Storage Conditions | Store in original sealed container at 15–25°C, protect from moisture |
| Shelf Life | 36 months from date of manufacture when stored as directed |
Q1: What is the primary function of Solvay BICAR PHARMA HEMODIALYSIS Pigment in hemodialysis-related pharmaceutical products?
A: This pigment is specifically developed to provide consistent, biocompatible coloration for components used in hemodialysis systems—such as dialysate concentrates, reconstitution solutions, or ancillary pharmaceutical preparations—supporting visual identification and quality control without compromising safety or performance.
Q2: Is Solvay BICAR PHARMA HEMODIALYSIS Pigment compliant with pharmaceutical-grade purity requirements?
A: Yes, it is manufactured under strict pharmaceutical quality management systems and meets the purity, traceability, and documentation expectations for use in medical device-associated pharmaceutical formulations. It is not intended for direct parenteral administration but is suitable for inclusion in externally administered dialysis solutions and related preparations.
Q3: How is this pigment typically incorporated into hemodialysis formulations?
A: It is generally added during the liquid-phase blending stage of concentrate preparation, where it disperses readily in aqueous media. Dosage depends on formulation requirements but is typically used at low concentrations to achieve the desired shade while maintaining solution clarity and stability.
Q4: Does this pigment affect the chemical stability or compatibility of dialysate solutions?
A: No adverse interactions have been observed with common dialysate electrolytes (e.g., sodium, potassium, calcium, bicarbonate) under standard storage and handling conditions. Stability testing confirms compatibility across typical pH and ionic strength ranges encountered in hemodialysis concentrate formulations.
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E-mail: wangxingqiang@ericwchem.com
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