Sodium 11 Na 22.989770

Sodium Acetate Trihydrate Pharma Pure, USP/EP/JP/BP Granulated

Jost Code: 8718

Synonyms: Acetic acid sodium salt trihydrate, Sodium acetate trihydrate

Sodium Acetate Trihydrate Pharma Pure, USP/EP/JP/BP Granulated can be used in pharmaceuticals. Product specifications, SDSs and certifications are available under Additional Information.

Chemical Formula
NaC2H3O2·3H2O
CAS Number
6131-90-4
Molecular Weight
136.1
Use
Pharmaceuticals
Description
White or colorless granulated
Containers
55 lb/25 kg carton; 110 lb poly drum; 26.4 lb/12 kg poly pail
Storage
Store in a clean, dry warehouse in the original unopened containers.
Revision Date
3/30/2022
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
Identification (JP)
Pass
Appearance of Solution
Pass
Clarity/Color of Soln.
Pass
Residual Solvents
Conforms to USP
LOD (USP)
38.0% - 41.0%
LOD (EP/BP)
39.0% - 40.5%
LOD (JP)
39.0% - 40.5%
Assay (USP)
99.0% - 101.0%
Assay (EP/BP)
99.0% - 101.0%
Assay (JP)
99.5% minimum
pH (USP)
7.5 - 9.2
pH (EP/BP)
7.5 - 9.0
Insoluble Matter
0.05% maximum
Reducing Substances
Pass
Chloride (USP)
350 ppm maximum
Chloride (EP/BP)
200 ppm maximum
Chloride (JP)
0.011% maximum
Sulfate (USP)
50 ppm maximum
Sulfate (EP/BP)
200 ppm maximum
Sulfate (JP)
0.017% maximum
Iron
10 ppm maximum
Ca and Mg (USP)
Pass
Ca and Mg (EP/BP)
50 ppm maximum
Ca and Mg (JP)
Pass
Potassium
Pass
Acidity or Alkalinity
Pass
KMnO4 Reducing Subst.
Pass
Particle Size
Mesh Thru 3 1/2
98% minimum
Mesh On 20
90% minimum
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 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.