Audited Supplier
0.9% 500ml Sodium Chloride Injection
Indications:Sodium Chloride Injection is indicated as a source of water and electrolytes.
0.9% Sodium Chloride injection is also indicated for use as a priming solution in hemodialysis procedures.
Contraindications:
Due to potential toxicity of benzyl alcohol in newborns, Bacteriostatic Sodium Chloride Injection, 0.9% containing benzyl alcohol must not be used in this patient population.
Bacteriostatic Sodium Chloride Injection, 0.9% should not be used for fluid or sodium chloride replacement.
Warnings:
Benzyl alcohol as a preservative in Bacteriostatic Sodium Chloride Injection, 0.9% has been associated with toxicity in newborns. Data is unavailable on the toxicity of other preservatives in this age group. Preservative-free Sodium Chloride Injection, 0.9% should be used for flushing intravascular catheters. Where a sodium chloride solution is required for preparing or diluting medications for use in newborns, only preservative-free Sodium Chloride Injection, 0.9% should be used.
Precautions:
Bacteriostatic Sodium Chloride Injection, 0.9% should not be used for those medicinals that specify the use of only Sodium Chloride Injection, 0.9% as a sterile solvent.
Sodium chloride must be used with caution in the presence of congestive heart failure, circulatory insufficiency, kidney dysfunction or hypoproteinemia.
Excessive amounts of sodium chloride by any route may cause hypopotassemia and acidosis. Excessive amounts by the parenteral route may precipitate congestive heart failure and acute pulmonary edema, especially in patients with cardiovascular disease and in patients receiving corticosteroids or corticotropin or drugs that may give rise to sodium retention.
Storage:
Store below 25ºC. Protect from light. KEEP OUT OF REACH OF CHILDREN.
Certificate of Analysis
| Testing terms | Standards | Results |
| Characteristic | A colorless clear solution | A colorless clear solution |
| pH | 4.5~7.0 | 5.4 |
| lron Salt | ≤2ppm | <2ppm |
| Sterility | Should be sterile | Sterile |
| Bacterial Endotoxin | <0.50USPEU/ml | <0.50USPEU/ml |
| Volume | Not less than the labeled volume | Complies |
| Visible Particles | Should be absent | Absent |
| Particulate matter | ≥10μm: not more than 25pcs per ml ≥25um: not more than 3pcs per ml | 0/ ml 0/ ml |
| Assay | 95.0%-105.0% | 101.1% |
