Test

Test 

Test

Standard

results

items

 methods

 unit

results

Apearance

USP

/

Pass

White crystal

Conform

Identification by FTIR

USP-EP

/

Pass

Pass

Conform

Color of solution

USP

/

Pass

Pass

Conform

Clarity of solution

USP

/

Pass

Pass

Conform

Assay

USP-EP

%

99.44

99-101

Conform

(on anhydrous basis)

Water

USP-EP

%

14.06

≤15

Conform

Acidity  or

USP-EP

/

Pass

Pass

Conform

alkalinity

o-Toluenesulphonamides

USP-EP

mg/kg

Pass

Pass

Conform

p-Toluenesulphonamides

USP-EP

mg/kg

Pass

Pass

Heavy metals

USP

mg/kg

<10

≤10

Conform

Benzoate and

USP

/

Pass

Pass

Conform

salicylate

Readily

USP-EP

/

Pass

Pass

Conform

carbonizable

substances

Organic

USP

/

Pass

Pass

Conform

volatile

 impurities

Aerobic plate count

QMIC-0002

cfu/g

<10

Conform

Yeasts and fungi (Molds)

QMIC-0002

cfu/g

<10

Conform

Gram Negative Bacilli

QMIC-0002

cfu/g

<10

Conform

 Staphlococcus aureus

QMIC-0002

cfu/g

0

Conform