Naphazoline hydrochloride USP, Ph.Eur.

Parameter	Spezification
Aspect	white or almost white crystalline powder
Identity (IR)	passes test
Identity (HPLC)	compare Rt
Identity for Chloride	passes test
Assay (HPLC, against St., dried Subst.)	98.0 - 102.0 %
Assay (ac. titr.) calc. on dried Subst.	99.0 - 101.0 %
Melting Range (Decomposition) (begin)	256 - 262 °C
Melting Range (Decomposition) (end)	256 - 262 °C
Sulphated ash	max. 0.10 %
Loss on Drying	max. 0.50 %
Solubility (2% in Water)	clear and colourless
pH-Value (1% in Water)	5.0 - 6.6
pH-Value (2% in Water)	5.0 - 6.5
Acidity/Alkalinity	passes test
Limit of Nitrate	passes test
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. 0.1%
1-Naphthylacetic acid (HPLC)	max. 0.10%
Unspecified impurities (HPLC)	max. 0.10%
Total impurities (HPLC)	max. 0.5%
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., USP [current edition]

Hazards identification
Skull and crossbones (GHS06)	Health hazard (GHS08)

Signal word
Danger

Hazard statements
H300	Fatal if swallowed.
H372	Causes damage to organs through prolonged or repeated exposure.

Precautionary statements
P411a	Store at temperatures not exceeding 30°C.
P260	Do not breathe 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.
P314	Get medical advice/attention if you feel unwell.
P301/310	IF SWALLOWED: Immediately call a POISON CENTER/doctor/....
P405	Store locked up.