USP FCC grade calcium gluconate powder is a highly purified form of calcium gluconate that meets both United States Pharmacopeia (USP) and Food Chemicals Codex (FCC) standards. It is a white, odorless, crystalline powder widely used in pharmaceuticals, dietary supplements, and food fortification.
What is USP FCC grade calcium gluconate powder used for?
This grade is ideal for injectable and oral pharmaceutical formulations, calcium supplements, and food products requiring strict purity. It also serves as a stabilizer and buffering agent. Because it complies with two rigorous monographs, it is trusted in regulated markets.
How do you choose a reliable calcium supplier or manufacturer?
Select a calcium manufacturer or calcium supplier with documented USP/FCC compliance, third-party testing, and GMP certification. China calcium salts producers often offer competitive pricing, but verify audit reports and batch consistency before committing to a long-term supply.
What quality parameters should you check?
- Assay: 98.5–101.0% (USP/FCC)
- Heavy metals: ≤10 ppm
- Loss on drying: ≤1.0%
- Microbial limits and particle size
Always request a Certificate of Analysis (CoA) for each lot to ensure the powder meets your application’s needs.
常见问题
What is the difference between USP and FCC grade calcium gluconate?
USP grade is intended for pharmaceutical use, while FCC grade is for food applications. USP FCC grade meets both sets of standards, making it suitable for pharmaceuticals, supplements, and food. This dual compliance ensures high purity and safety.
How should USP FCC grade calcium gluconate powder be stored?
Store in a cool, dry place away from moisture and direct sunlight. Keep the container tightly closed to prevent caking. Under these conditions, the powder remains stable for at least two years.
Can USP FCC grade calcium gluconate powder be used in injectable solutions?
Yes, USP grade calcium gluconate is commonly used in injectable preparations, such as calcium replacement therapy. However, it must be handled under sterile conditions and according to pharmacopeial guidelines. Always confirm the specific grade meets your formulation requirements.
