Ferric Maltol

Sr. No.

Test

Specification

01

Description

Light brown to reddish brown powder.

02

Identification by Infrared spectroscopy

The infrared spectrum of the test preparation should exhibit maxima at the characteristic wavenumbers 1565, 1501, 1274 and 1203 cm^-1 (10 cm^-1).

03

PH (1.0 % solution in water)

Between 5 and 8

04

Water Content By KF

Not more than 2.0% w/w                           

05

Loss on drying

(105 C for 3 hrs.)

Not more than 2.0 % w/w

06

Iron content by UV (On dried basis)

Between 12% w/w to 14% w/w                               

07

 Maltol content by HPLC (On dried basis)

Between 86% w/w to 88% w/w 

08

Related substances by HPLC:

Citric acid           

Any unspecified impurity

Total impurities

Not more than 0.15%

Not more than 0.10%

Not more than 1.0%

09

Iron (II) content by titrimetry

Not more than 0.15 % w/w

10

X-ray Diffraction

X-ray diffractogram of the test sample should show polymorphic Form-II characteristic 2qvalues at 8.3,9.5,11.8, 14.5,15.5,19.2,19.8,21.1 and 23.0        (0.2).

11

Microbial Enumeration Test :

(A) Total Aerobic Microbial Count     (TAMC)

NMT 1000 cfu/g.

(B) Total Combined Yeast and Mold Count  (TYMC)

NMT 100 cfu/g.