Items

Specification

Characters

White or off-white crystalline powder

Identification

IR should comply with the reference standard spectrum

UV should comply with the reference standard spectrum

Melting range

186 ~ 189ºC

Volatile diazoizable substance

≤0.002%

Loss on drying

≤0.2%

Residue on ignition

≤0.1%

Related substances

( HPLC)

Nitrobenzoic acid

Benzocaine<0.2%

Any unspecified impurity<0.1%

Total impurities<0.5%

Anilineand Poluidine (GC )

Anilin<10ppm

Ptoluidine<l0ppm

Heavy metal

≤0.002%

Pb

≤0.05%

As

≤0.005%

Cr

≤0.005%

Hg

≤0.003%

Salmonella

Not detected

Total plate count

< 10cfu/g

Coliform bacteria

< 10cfu/g

Colibacillus

< 10cfu/g

Mould

< 10cfu/g

Yeast

< 10cfu/g

Staphylococcus aureus

< 10cfu/g

Assay

98.5 ~ 101.5%

Ordinary impurity

≤ 1%