Ferrous Fumarate (IP/BP/USP/EP)

PRODUCT NAME

 

FERROUS FUMARATE - IP/BP/USP/EP

Chemical formula 

 

C4H2FeO4

Molecular weight   

 

169.90

Standard pack size

 

25 KG. PAPER BAG / 50 KG. HDPE BAG

Retest period

 

5 Years from the date of manufacture

Application

 

 


  

Sr. No.

TEST

SPECIFICATION

REFERENCE

1.

Description

A Reddish orange to reddish Brown, fine Powder may contain soft lumps that Produce a yellow streak when crushed; Odor, slight.

IP

2.

Solubility

Slightly Soluble in Water; very slightly soluble in ethanol (96%)

IP

3.

Identification

A) Filtrate gives reaction a of ferrous salt.

(B) Potassium permanganate is Decolorized and A brownish solution is obtained.

(C) An orange-yellow solution without any fluorescence is obtained

IP

4.

ARSENIC

Not more than 5 ppm

IP

5.

HEAVY METALS

Not more than 20 ppm.

IP

6.

SULPHATE                          

Not more than 0.1%.

IP

7.

FERRIC IRON 

Not more than 2.0 %.

IP

8

LOSS ON DRYING

Not more than 1.0%.

IP

9

ASSAY

NLT 93.0% & NMT 101.0%

IP



Sr. No.

TEST

SPECIFICATION

REFERENCE

1.

Description

Fine Reddish orange or reddish Brown Powder.

BP

2.

Solubility

Slightly Soluble in Water; very slightly soluble in ethanol (96%)

BP

3.

Identification

(A) The principle spot in the Chromatogram obtained with the test solution is similar in position and size to the principle spot in the chromatogram obtained with the Reference solution.

(B) An orange-yellow color develops and the solution shows no Fluorescence.

(©The obtained for the Test solution in identification test A shows reaction (a) of iron.

BP

4.

Sulphate                          

Not more than 0.2%.

BP

5.

Arsenic

Not more than 5 ppm.

BP

6.

Ferric iron  

Not more than 2.0 %.

BP

7.

Cadmium        

Not more than 10 ppm.

BP

8

Chromium                      

Not more than 200 ppm.

BP

9

Lead               

Not more than 20 ppm.

BP

10

Mercury

Not more than 1 ppm

BP

11

Nickel

Not more than 200 ppm.

BP

12

Zinc

Not more than 500 ppm.

BP

13

Lod

Not more than 1.0 %.

BP

14

Assay (On Dry Basis) 

NLT 93.0% & NMT 101.0%

BP


Sr. No.

TEST

SPECIFICATION

REFERENCE

1.

Description

Reddish -orange to red Brown, Odourless Powder. May contain soft lumps that Produce a yellow streak when crushed.

USP

2.

Solubility

Slightly Soluble in Water; very slightly soluble in alcohol. Solubility in dilute hydrochloride acid is limited by the separation of Fumaric acid

 

USP

3.

Identification

(A) The IR absorption of a potassium bromide dispersion of the dried precipitate exhibits maxima only at the same wavelengths as that of a similar preparation of USP Fumaric Acid RS.

(B) A portion of the filtrate obtained in identification test A meets the requirements.

USP

4.

Lod

Not more than 1.5 %.

USP

5.

Sulphate

Not more than 0.2%.

USP

6.

Arsenic

Not more than 3 ppm.

USP

7.

Ferric iron  

Not more than 2.0 %.

USP

8.

Lead   

Not more than 10 ppm

USP

9.

Mercury

NMT 3 ppm

USP

10.

Assay(on dry basis)    

NLT 97.0% & NMT 101.0%

USP


Sr. No.

TEST

SPECIFICATION

REFERENCE

1.

Description

Fine, Reddish orange or reddish Brown Powder.     

EP

2.

Solubility

Slightly Soluble in Water; very slightly soluble in ethanol (96%) 

EP

3.

Identification

(A) TLC

The principle spot in the Chromatogram obtained with the test solution is similar in position and size to the principle spot in the chromatogram obtained with the working standard solution.

(B) An orange-yellow color develops and the solution shows no Fluorescence.

© The filtrate obtained during preparation of test solution in the identification test A shows reaction (a)  of iron

EP

4.

Sulphate                          

Not more than 0.2%.

EP

5.

Arsenic

Not more than 5 ppm.

EP

6.

Ferric iron  

Not more than 2.0 %.

EP

7.

Cadmium        

Not more than 10 ppm.

EP

8

Chromium                      

Not more than 200 ppm.

EP

9

Lead               

Not more than 20 ppm.

EP

10

Mercury

Not more than 1 ppm

EP

11

Nickel

Not more than 200 ppm.

EP

12

Zinc

Not more than 500 ppm.

EP

13

Lod

Not more than 1.0 %.

EP

14

Microbial contamination

Total aerobic microbial count (1AMC) 103CFU per 1g

Total  yeast and mould count (1YMC) 102CFU per 1g

EP

15

Assay (On Dry Basis) 

Not Less than  93.0% &Not More than 101.0%

EP