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Pharmaceutical-grade sodium bicarbonate meeting ICH Q5, Q7, and EP/USP monograph requirements.
Consistent high purity with low heavy metal content (e.g., Pb < 2 ppm, As < 1 ppm) and controlled microbial limits.
Controlled particle size distribution for optimal flowability and blend uniformity in solid dosage formulation.
Non-GMO, animal-free manufacturing process compliant with regulatory expectations for biologics and sensitive APIs.
Stabilized crystalline form ensuring long-term chemical stability under recommended storage conditions.
Buffering agent in parenteral and oral pharmaceutical formulations.
pH adjuster in biopharmaceutical processing and cell culture media.
Excipient in effervescent tablets and lyophilized drug products.
Alkalinizing agent in diagnostic reagents and in vitro diagnostic (IVD) kits.
Processing aid in API crystallization and purification steps.
| Chemical Type | Sodium bicarbonate (NaHCO₃) |
| Product Form | Free-flowing white crystalline powder |
| Appearance | White, odorless, fine to medium granulation |
| Primary Applications | Pharmaceutical excipient and API processing aid |
| Key Features | EP/USP compliant, low endotoxin, low moisture (< 0.5% w/w) |
| Benefits | Enhanced batch-to-batch consistency, reduced risk of formulation variability |
| Storage Conditions | Store in original sealed container at 15–25°C, protect from moisture |
| Regulatory Status | DMF available; compliant with ICH Q5, Q7, and Annex I of EU GMP |
Q1: What is the primary function of Solvay BICAR PHARMA API Pigment in pharmaceutical formulations?
A: Solvay BICAR PHARMA API Pigment is a high-purity, pharma-grade colorant designed to provide consistent, stable visual identification in solid oral dosage forms—such as tablets and capsules—while meeting stringent quality and safety expectations for active pharmaceutical ingredient (API) handling environments.
Q2: Is this pigment compatible with common tablet excipients and processing conditions?
A: Yes, Solvay BICAR PHARMA API Pigment demonstrates good compatibility with widely used pharmaceutical excipients—including microcrystalline cellulose, lactose, and croscarmellose sodium—and remains stable under standard wet granulation, dry blending, and direct compression conditions.
Q3: How is Solvay BICAR PHARMA API Pigment manufactured to ensure suitability for pharmaceutical use?
A: It is produced under strict GMP-aligned manufacturing controls, including dedicated equipment, controlled environmental conditions, and comprehensive batch documentation. Raw materials are qualified for pharmaceutical use, and final product undergoes rigorous testing for residual solvents, heavy metals, microbial limits, and particle size distribution.
Q4: What regulatory support documentation is available for this pigment?
A: Solvay provides comprehensive regulatory support, including a Drug Master File (DMF) reference, Certificate of Analysis (CoA), Certificate of Compliance, and technical dossiers outlining manufacturing process, impurity profiles, and stability data—supporting global regulatory submissions for finished pharmaceutical products.
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E-mail: wangxingqiang@ericwchem.com
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