SL.

NO.

                                                        TESTS

                            SPECIFICATIONS                         

                RESULTS           

01

02

03

04

05

06

07

08

09

10

Description

Solubility

Identification

a)      IR

b)      Test for

Potassium

Clarity

Color Index

PH of 5% w/v Aq solution

Loss On Drying

Heavy Metals

Assay

Related Substances by (HPLC)

A White to off- White crystalline powder.

Soluble in Water and methanol

The IR Spectrum is concordant

With the spectrum of standard.

Response to reactions of potassium. 

A 5% w/v solution in water is clear and free from any extraneous matter

Absorbance if I cm layer of 5% w/v solution in methanol at 420 mm is less than 0.08.

8.4 9.6

Not More than 1.0% w/w

Not more than 20 p pm

98.5 101.5% on dried basis

Purity by HPLC : NLT:99.0%

Single Impurity : NMT: 0.5%

Total Impurities : NMT : 1.0%

A White color crystalline powder.

complies

Complies

Complies

complies

Not less than 98.50% w/w

complies

8.95

0.60% w/w

complies

99.10%

99.80%

0.15%

0.20%