Sodium 11 Na 22.989770

Sodium Carbonate Anhydrous Pharma Pure, NF/EP/JP/BP Fine Granular

Jost Code: 8746

Synonyms: Calcined soda, Carbonic acid disodium salt, Soda ash

Sodium Carbonate Anhydrous Pharma Pure, NF/EP/JP/BP Fine Granular can be used in pharmaceuticals and oral care. Product specifications, SDSs and certifications are available under Additional Information.

Chemical Formula
Na2CO3
CAS Number
497-19-8
Molecular Weight
106.0
Use
Pharmaceuticals; Oral care
Description
White granular
Containers
55 lb/25 kg fiber carton; 26.4 lb/12 kg poly pail; 110 lb/50 kg poly drum
Storage
Store in a clean, dry warehouse in the original unopened containers.
Revision Date
09/14/2021
ID Test A (NF)
Pass
ID Test B (NF)
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
Identification (JP)
Pass
Appearance of Solution
Pass
Clarity/Color of Solution
Pass
Residual Solvents
Conforms to NF
Water (NF)
0.5% Maximum
LOD (EP/BP)
1.0% Maximum
LOD (JP)
2.0% Maximum
Assay (NF)
99.5% – 100.5%
Assay (EP/BP)
99.5% – 100.5%
Assay (JP)
99.0% Minimum
Chloride (EP/BP)
125 ppm Maximum
Chloride (JP)
0.071% Maximum
Iron
50 ppm Maximum
Sulfate
250 ppm Maximum
Alk. Hydroxides/Bicarb.
Pass
Heavy Metals
10 ppm Maximum
Arsenic
3.1 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.