Sodium 11 Na 22.989770

Sodium Phosphate Dibasic Heptahydrate Pharma Pure, USP Multi-Compendial, Granular

Jost Code: 8782

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

Sodium Phosphate Dibasic Heptahydrate Pharma Pure, USP Multi-Compendial, Granular can be used in pharmaceuticals and as a buffering agent. Product specifications, SDSs and certifications are available under Additional Information.

Chemical Formula
Na2HPO4 · 7H2O
CAS Number
7782-85-6
Molecular Weight
268.07
Use
Pharmaceuticals; Buffering agent
Description
Granular
Containers
110 lb/50 kg fiber drum; 55 lb/25 kg carton; 110 lb poly drum; 26.4 lb poly pail
Storage
Store in a clean, dry warehouse in the original unopened containers. Substance may agglomerate in storage. It may be gently deagglomerated and screened prior to use.
Revision Date
11/15/2023
ID Test Alkalinity
Pass
ID Test Phosphate (USP)
Pass
ID Test Phosphate (EP)
Pass
ID Test Sodium (USP/EP)
Pass
ID Test 1 (JP)
Pass
ID Test 2 (JP)
Pass
ID Test 3 (JP)
Pass
Appearance
Pass
Solution Appearance (EP)
Pass
Solution Appearance (JP)
Pass
Residual Solvents
Conforms to USP
LOD
43.0% - 50.0%
Assay (USP)
98.0% - 100.5%
Assay (EP)
98.5% - 102.5%
Assay (JP)
98.0% Minimum
pH (1.5%) (JP)
9.0 - 9.4
pH (5%)
8.4 - 9.6
Insoluble Matter
0.4% maximum
Chloride (USP)
0.06% maximum
Chloride (EP)
200 ppm Maximum
Chloride (JP)
0.014% Maximum
Iron (EP)
20 ppm Maximum
Sulfate (USP)
0.2% Maximum
Sulfate (EP)
500 ppm Maximum
Sulfate (JP)
0.038% Maximum
Carbonate (JP)
Pass
Monosodium Phos (EP)
Pass
Reducing Substances (EP)
Pass
Arsenic
2 ppm maximum
Heavy Metals
10 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
2.5 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.