Sodium 11 Na 22.989770

Sodium Phosphate Monobasic Monohydrate Pharma Pure, USP/BP Multi-Compendial, Granular

Jost Code: 8767

Synonyms: Sodium dihydrogen phosphate monohydrate

Sodium Phosphate Monobasic Monohydrate Pharma Pure, USP/BP Multi-Compendial, Granular can be used as a pharmaceutical and buffering agent. Product specifications, SDSs and certifications are available under Additional Information.

Chemical Formula
NaH2PO4 · H20
CAS Number
10049-21-5
Molecular Weight
137.99
Use
Pharmaceuticals; Buffering agent
Description
White granules
Containers
110 lb/50 kg fiber drum; 55 lb/25 kg carton; 100 lb poly drum; 26.4 poly pail
Storage
Store in a clean, dry warehouse in the original unopened containers.
Revision Date
05/23/2022
Identification
Test A (BP)
Pass
Test B (BP)
Pass
Test C (BP)
Pass
Test D (BP)
Pass
Test A (USP)
Pass
Test B (USP)
Pass
Appearance
Pass
Solution Color & Clarity
Pass
Residual Solvents
Pass
Water
10.0% - 15.0%
LOD
11.5% - 14.5%
Assay (BP)
98.0% - 100.5%
Assay (USP)
98.0% - 103.0%
Acidity/pH (5%)
4.2 - 4.5
Insoluble Substances
0.2% maximum
Chloride (BP)
200 ppm maximum
Chloride (USP)
0.014% maximum
Chloride (JPE)
0.005% maximum
Iron
10 ppm maximum
Sulfates (BP)
300 ppm maximum
Sulfates (USP)
0.15% maximum
Sulfates (JPE)
0.019% maximum
Ca Al & Related Elements
Pass
Reducing Substances
Pass
Heavy Metals
10 ppm maximum
Arsenic
2 ppm maximum
Microbial Test Results
Aerobic Plate Count
10³ cfu/g maximum
Yeast and Mold Count
10² cfu/g maximum
Total Coliforms
Negative
Bacterial Endotoxins
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.