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Trisodium Citrate Dihydrate EP/USP 25 kg bag

- Commercial Name: Trisodium Citrate Dihydrate
- Chemical Formula: C ₆ H ₅ Na ₃ O ₇ · 2H ₂ O
- Molecular Weight : 294.1 g/mol
- CAS Number: 6132-04-3
- Appearance : White to beige crystalline powder
Description:
Trisodium Citrate Dihydrate is a high-purity alkali metal citrate salt with an assay of 99.0–100.5% on a dried basis. Available in EMPROVE® EXPERT grade from Merck KGaA, it complies with multiple international pharmacopoeial standards including Ph. Eur., BP, ChP, JP, and USP, as well as ACS and food additive E 331 requirements under current European Commission regulations. This multifunctional excipient is valued for its excellent buffering capacity, chelating properties, and high water solubility. It meets stringent microbiological and elemental impurity specifications per ICH Q3D guidelines, including endotoxin limits (≤2.5 IU/g), making it fully suitable for parenteral pharmaceutical applications. Its plant-based origin, GMO-free status, and broad regulatory compliance support use across global pharmaceutical and food supply chains.
Typical Applications
- Buffering agent in injectable and parenteral pharmaceutical formulations
- Anticoagulant in blood collection and transfusion medicine
- Sequestrant and acidity regulator in food and beverage processing (E 331)
- Chelating agent in cosmetic and personal care formulations
- Emulsifying salt in processed cheese production
- Raw material for pharmaceutical and food-grade buffer preparation
Key Features
- High purity (99.0–100.5% on dried basis)
- Multi-compendial compliance: Ph. Eur., BP, USP, JP, ChP, ACS, E 331
- EMPROVE® EXPERT grade (Merck KGaA)
- Endotoxin tested (≤2.5 IU/g) — suitable for parenteral use
- ICH Q3D elemental impurity compliant
- Plant-based origin, GMO-free, BSE/TSE-free, allergen-free
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- Started from: Dec 14, 2022
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