Sodium Acetate Trihydrate

EP, USP + LEC + Microbiological requirements

CAS #:

6131-90-4

Molecular Formula:

C2H3NaO2 . 3H2O

Synonym:

N/A

Molecular Weight:

136.08 g/mol

Overview

Sodium Acetate, Trihydrate is used as a source of sodium ions in solutions for dialysis and as a systemic and urinary alkalizer, diuretic and expectorant. In pharmaceutical industry, it is used for replenishing lost electrolytes, as a diuretic, and in reusable heating pads and hand warmers.

Characters Unit Specification
Identity A (EP,BP) Acc.to requirements
Identity B (EP,BP) Acc.to requirements
Identity C (EP,BP) Acc.to requirements
Identity A (USP) Acc.to requirements
Identity B (USP) Acc.to requirements
Appearance of solution (EP,BP) Correlates to test
Reducing substances EP/BP Correlates to test
Calcium and magnesium (USP) Correlates to test
Potassium (USP) Correlates to test
Residual solvents (USP) Correlates to test
Assay (EP,BP) % 99,0-101,0
Assay (USP) % 99,0-101,0
Loss on drying (EP,BP) % 39,000-40,500
Loss on drying (USP/NF) % 38,00-41,00
Aluminium (ICP) mg/kg <=0,2
Arsenic (EP,BP) mg/kg <=2,0
Sulfates (EP,BP) mg/kg <=200,0
Heavy Metals (as Pb) mg/kg <=10,0
Iron (EP,BP) mg/kg <=10,0
Chlorides (EP,BP) mg/kg <=200,0
Calcium and magnesium EP/BP mg/kg <=50,0
Sulphates (USP) mg/kg <=50,0
Chlorides (USP) mg/kg <=350,0
pH (3%) 7,50-9,20
pH (5%) 7,50-9,00
Insoluble matter in water % <=0,050
Bacterial endotoxin lU/g <=5,000
TAMC 30oC (Total aerobic microbial count) cfu/g <=50
TYMC cfu/g <=10
Escherichia coli cfu/g
Staphylococcus aureus cfu/g
Pseudomonas aeruginosa cfu/g
Salmonella cfu/10g

Shelf Life/Retest Date: Sodium Acetate Trihydrate can be kept for at least 3 years if stored in a cool and dry place under recommended conditions.

Storage/Shipping Conditions:

  • Keep container tightly closed in a cool, well-ventilated place.
  • Storage temperature recommended: < 25°C

Pack Sizes: 5 Kg

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