Benzocaine

Items of Test

Standard

Result of Test

Appearance

White crystals or crystalline powder

White crystals

Solubility

Freely soluble in alcohol,in chloroform and in ether,sparingly soluble in olive oil, very slightly soluble in water,dissolves in diluted acids

Conforms

Melting point

88-92℃

90.0-90.5℃

Melting range

Not more than 2℃

0.5℃

Identification

A.     IR should comply with the reference standard spectrum

B.      UV should comply with the reference standard spectrum

C.      An orange red precipiate is performed

Conforms

Conforms

Conforms

Loss on drying

Not more than 0.5%

0.18%

Readily carbonizable substances

The resolution has no more color than matching fluid A

Conforms

Residue of ignition

Not more than 0.10%

0.01%

Heavy metal

Not more than 0.001%

Conforms

Chloride

Should conform

Conforms

Assay

98.0%-102%

99.98%

Related substances(HPLC)

A.    Any single known impurity ≤0.10%

B.     Any single unknown impurity ≤0.10%

C.     Total impurity ≤0.5%

Not detected

0.003%

0.005%

Ordinary impurities (TLC)

≤1.0%

Conforms

Reaction

Should conformf

Conforms

Total numbers of colony

Not more than 80cfu/g

Conforms

Yeasts and Molds

Not more than 80cfu/g

Conforms

Live mites and mite eggs

No live mite is detected

Not detected

E.Coli

Negative

Conforms

Staphylococcus aureus

Negative

Conforms

Pseudomonas aeruginosa

Negative

Conforms