Sodium 11 Na 22.989770

Sodium Phosphate Dibasic Dihydrate Pharma Pure, USP/EP/BP Granular

Jost Code: 8776

Synonyms: Disodium hydrogen phosphate dihydrate, Disodium phosphate dihydrate, Sodium hydrogenphosphate dihydrate

Sodium Phosphate Dibasic Dihydrate Pharma Pure, USP/EP/BP Granular can be used in pharmaceuticals and as a buffering agent. Product specifications, SDSs and certifications are available under Additional Information.

Chemical Formula
Na2HPO4 · 2H2O
CAS Number
10028-24-7
Molecular Weight
178.0
Use
Pharmaceuticals; Buffering Agent
Description
Granular
Containers
110 lb/50 kg poly drum; 26.4 lb/12 kg poly pail; 55 lb/25 kg carton
Storage
Store in a clean, dry warehouse in the original unopened containers.
Revision Date
9/10/2021
ID Test A (USP)
Pass
ID Test B (USP)
Pass
ID Test A (EP/BP)
Pass
ID Test B (EP/BP)
Pass
ID Test C (EP/BP)
Pass
ID Test D (EP/BP)
Pass
Appearance of Solution
Pass
LOD
19.5% – 21.0%
Assay (USP)
98.0% – 100.5%
Assay (EP/BP)
98.0% – 101.0%
Insoluble Substances
0.4% maximum
Monosodium Phosphate
2.5% maximum
Chloride (USP)
0.06% maximum
Chloride (EP/BP)
400 ppm maximum
Iron
40 ppm maximum
Sulfate (USP)
0.2% maximum
Sulfate (EP/BP)
0.1% maximum
Reducing Substances
Pass
Arsenic
4 ppm maximum
Microbial Test Results
Aerobic Plate Count
10³ cfu/g maximum
Yeast and Mold Count
10² cfu/g maximum
Total Coliforms
Negative
Bacterial Endotoxin
15 EU/g maximum
Endotoxin results do not imply process conditions intended to limit or control the presence of endotoxins. Drug products produced from this substance for parenteral or other sensitive applications must be filtered, sterilized, and/or depyrogenated. Drug product testing for endotoxins is also recommended.