Product name: Brimonidine Tartrate

Expiry date:2 years

ITEMS

SPECIFICATION

RESULTS

Appearance  

Off-white or slight yellow crystalline powder

Conforms

Solubility

Sparingly soluble in water, insoluble in methanol, acetone

Conforms

Identification

a)      IR

b)      Retention time(HPLC)

Conforms to standard

Conforms to standard

Conforms

Conforms

Appearance of solution

The solution is not more opalescent than reference suspension I and not more intensely colored than reference solution Y7(1 in 10 carbon dioxide-free water R )

conforms

Melting Point

204-209ºC

205.3-207.2 ºC

PH

3-4

(i in 10 carbon dioxide-free water R)

3.2

Loss on drying

≤0.5%at 100ºC to the constant weight

0.04%

Sulphated Ash

≤0.1%

0.01%

Heavy metals

≤20ppm

<20ppm

Related substances

Single impurities≤0.5%

Total impurity≤1.0%

0.08%

0.15%

Residual solvents

Ethanol: ≤ 0.5%; Acetone:≤ 0.5%

Conforms

Specific Rotation

+9.0° to +10.5°

+9.8°

Purity

99.0-101.0%(C11H10Br5.C4H6O6)

( on dry basis)

99.85%

CONCLUSION:

The product complies with enterprise standard