PRODUCT NAME:OLOPATADINE HCL

EXPIRY DATE:3 years

CAS NO.:

Items

Standards

Results

Appearance

White crystalline powder

White crystalline powder

Solubility

Soluble in methanol, sparingly soluble in water.

Complies

Identification

UV

Absorb at 298nm

IR

Positive

Relative Substance

Total NMT 1.0%

Single NMT 0.5%

0.19%

0.11%

Residual Solvents

Methanol        NMT0.3%

Toluene         NMT 0.089%

Tetrahydrofuran NMT0.072%

Acetone         NMT0.5%

Complies

Loss on Drying

NMT 0.5%

0.16%

Residue on Ignition

NMT 0.1%

0.09%

Heavy Metals

NMT 20ppm

LT 20ppm

Assay(by titration)

NLT 98.5%

100.1%

CONCLUSION: IT COMPLIES WITH IN-HOME STANDARDS.