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 |
Contact With Us:
E-mail: wangxingqiang@ericwchem.com
Have a Questions? Call Us:
Add:
Building A1, Jiete Industrial Park, Huangpu District, Guangzhou City, Guangdong Province, China