| Parameter | Spezification |
|---|---|
|
Aspect |
white or almost white crystalline powder |
|
Identity |
passes test |
|
Assay (NT) calc. on dried Substance |
99.0 - 101.0 % |
|
Melting Range (begin) |
167 - 170 °C |
|
Melting Range (end) |
167 - 170 °C |
|
Sulphated ash |
max. 0.10 % |
|
Loss on Drying |
max. 0.50 % |
|
Solubility (1% in Water) |
clear and colourless |
|
pH-Value (1% in Water) |
5.0 - 6.5 |
|
Chloride (Cl) |
max. 330 ppm |
|
Acetone (GC) |
max. 1,000 ppm |
|
Benzene (GC) |
max. 2.000 ppm |
|
Diisopropyl ether (GC) |
max. 500 ppm |
|
Isopropyl alcohol (GC) |
max. 5,000 ppm |
|
Impurity A (HPLC) |
max. 0.5% |
|
Unspecified impurities (HPLC) |
max. 0.10% |
|
Total impurities (HPLC) |
max. 1.0% |
|
Sum TAMC + TYMC |
max. 100 CFU/g |
|
Enterobacteria |
absence in 1 g |
|
Pseudomonas aeruginosa |
absence in 1 g |
|
Staphylococcus aureus |
absence in 1 g |
|
Escherichia coli |
absence in 1g |
|
Salmonella |
absence in 10 g |
|
Requirement |
Ph.Eur. [current edition] |
Naphazoline nitrate Ph.Eur.
| Hazards identification |
|---|
 Exclamation mark (GHS07) |
| Signal word |
|---|
|
Warning |
| Hazard statements | |
|---|---|
|
H302/312/332 |
Harmful if swallowed, in contact with skin or if inhaled. |
| Precautionary statements | |
|---|---|
|
P411a |
Store at temperatures not exceeding 30°C. |
|
P261 |
Avoid breathing dust/fume/gas/mist/vapours/spray. |
|
P264 |
Wash with water and soap thoroughly after handling. |
|
P270 |
Do not eat, drink or smoke when using this product. |
|
P310 |
Immediately call a POISON CENTER or doctor. |
|
P321 |
Specific treatment (see ... on this label). |
|
P330 |
Rinse mouth. |