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LOSARTAN POTASSIUM



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Product Code : 18

Product Specification

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%

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