Department Document No.

Focus & Rulz Pharmaceuticals (Pvt.) Ltd. Quality Control FR/ QCD/SAP/164
Effective Date Next Revision Date
Standard Analytical Procedure 01-04-2021 01-04-2024
M-Fer Oral Drops Revision Date Revision No.

26-03-2021 00
Prepared by: Sign with Date Reviewed by: Sign with Date Approved by: Sign with Date Authorized by: Sign with Date

Quality Control Analyst Quality Control Manager Quality Assurance Manager Plant Manager

1.0 Purpose
This SAP describes the chemical testing of the product.
2.0 Scope
This procedure is applicable to the following stages:
a. Bulk Solution
b. Finished. (Filled Bottles)
3.0 Composition:
3.1 M-Fer Oral Drops
Each ml contains:
Iron (III) Hydroxide Polymaltose Complex eq. to elemental Iron ……50mg
3.2 Product Specifications: F & R Specs
3.3 pH of Syrup
Between 5.0– 8.0, check the pH with calibrated pH meter.
4.0 Factor
Iron: Depending upon the assay of raw material, between the limits of iron contents as 28 % to
36%.
5.0 Identification
Iron:
By UV- The spectrum of the Sample Preparation obtained exhibits a major peak for Iron, which
corresponds to that exhibited in the spectrum of the Standard Preparation at the same wave
length in the visible region.
6.0 Assay For Iron:
Method I : (UV) Ref : IH
6.1 Requirements
a. Glassware

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Controlled Copy: Do not Duplicate Page 1 of 5
 Department Document No.
Focus & Rulz Pharmaceuticals (Pvt.) Ltd. Quality Control FR/ QCD/SAP/164
Effective Date Next Revision Date
Standard Analytical Procedure 01-04-2021 01-04-2024
M-Fer Oral Drops Revision Date Revision No.

26-03-2021 00
Prepared by: Sign with Date Reviewed by: Sign with Date Approved by: Sign with Date Authorized by: Sign with Date

Quality Control Analyst Quality Control Manager Quality Assurance Manager Plant Manager

Pipettes, Beaker, Volumetric Flask, Conical Flask, Funnel.

b. Instruments
i. UV-VIS Spectrophotometer
ii. Analytical Balance
c. Reagents/ Chemicals
i. Nitric acid
ii. HCl
iii .Ammonium Thiocynate.
iv. 0.1N H2SO4
d. Preparation of Solution
Ammonium Thiocynate solution (10%):
Dissolve 10g of Ammonium Thiocynate in 100ml of volumetric flask. Make up volume with
distilled water.
6.2. Procedure
Standard Preparation
Transfer accurately weighed an amount of Iron Polymaltose Complex WS (equivalent to 100mg
of iron) into a 100 ml volumetric flask, with 1ml of nitric acid and 5ml of hydrochloric acid for
hydrolysis over a water bath for 2 minutes, cool at room temperature and make up volume to
100ml with distilled water. Stir.
Transfer 3ml of the filtrate and 3ml of the Ammonium Thiocynate (10%) solution into a 50 ml
volumetric flask and make up volume to 50ml with 0.1N H2SO4.Shake well.
Sample Preparation
a) Bulk Solution:
Accurately take 10ml of Solution equivalent to 100mg of iron in a 100ml volumetric flask, with
1ml of nitric acid and 5ml of hydrochloric acid for hydrolysis over a water bath for 2 minutes,

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Controlled Copy: Do not Duplicate Page 2 of 5
 Department Document No.
Focus & Rulz Pharmaceuticals (Pvt.) Ltd. Quality Control FR/ QCD/SAP/164
Effective Date Next Revision Date
Standard Analytical Procedure 01-04-2021 01-04-2024
M-Fer Oral Drops Revision Date Revision No.

26-03-2021 00
Prepared by: Sign with Date Reviewed by: Sign with Date Approved by: Sign with Date Authorized by: Sign with Date

Quality Control Analyst Quality Control Manager Quality Assurance Manager Plant Manager

cool at room temperature and make up volume to 100ml with distilled water. Stir and filter
through a filter paper discarding first few ml of the solution.
Transfer 3ml of the filtrate and 3ml of the ammonium Thiocynate (10%) solution into a 50ml
volumetric flask and make up volume to 50ml with 0.1N H2SO4. Shake well.
b) Finished:
Take accurately 10ml of Syrup while shaking well the syrup, equivalent to 100mg of iron in a
100 ml volumetric flask, with 1ml of nitric acid and 5ml of hydrochloric acid for hydrolysis over
a water bath for 2 minutes, cool at room temperature and make up volume to 100ml with distilled
water. Stir and filter through a filter paper discarding first few ml of the solution.
Transfer 3ml of the filtrate and 3ml of the Ammonium Thiocynate (10%) solution into a 50ml
volumetric flask and make up volume to 50ml with 0.1N H2SO4. Shake well.
6.3 Results
Measure the absorbance of standard and sample solutions at 471 nm using 3ml of the ammonium
Thiocynate (10%) solution into a 50 ml volumetric flask and make up volume to 50ml with 0.1N
H2SO4 as blank.
6.4 Calculations
Calculate mg per 5ml as well as the percentage results by following formula.
Formula:
mg/5ml:
= Abs. of Smp. x Wt of Std x 3 x 100 x 50 x 5 x Potency of WS
Abs. of Std. 100 50 Vol of Smp (10ml) 3 100

Assay (%age) = Calculated amount (mg/5ml) x100

Labeled amount (mg/5ml)
6.5 Assay Limits
90.0 to 110.0% of the stated amount.

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Controlled Copy: Do not Duplicate Page 3 of 5
 Department Document No.
Focus & Rulz Pharmaceuticals (Pvt.) Ltd. Quality Control FR/ QCD/SAP/164
Effective Date Next Revision Date
Standard Analytical Procedure 01-04-2021 01-04-2024
M-Fer Oral Drops Revision Date Revision No.

26-03-2021 00
Prepared by: Sign with Date Reviewed by: Sign with Date Approved by: Sign with Date Authorized by: Sign with Date

Quality Control Analyst Quality Control Manager Quality Assurance Manager Plant Manager

7.0 Method II : (Iodometric) Ref : IH

7.1 Requirements
a. Glassware
Pipettes, Beaker, Stopered Flask, Iodine flask, Burette, Funnel
b. Instruments
i. Titration assembly
ii. Analytical Balance
c. Reagents/ Chemicals
i. Conc. HCl
ii. Potassium iodide
iii. 0.1N Sodium Thiosulphate
iv. 1% Starch
d. Preparation of Solution
0.1 N Sodium Thiosulphate Solution
Dissolve 2.482g Sodium Thiosulphate in 100mL water.
1% Starch Solution
Dissolve 0.5g starch in 50mL hot water to prepare 1% starch solution.
7.2. Procedure
Sample Preparation
a) Bulk Solution:
Accurately take 10 ml of the syrup equivalent to 100mg of iron in a glass stopered flask.
Dissolve in a mixture of 10ml of conc. HCl and 100ml Distilled water. Boil for 15 seconds, cool,
if not cooled will give false low assay. Add 2 g potassium Iodide. Allow to stand for 20 minutes
in dark area. Add 2ml of 1% starch solution and titrate with 0.1N Sodium Thiosulphate solution
until blue color disappears.

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Controlled Copy: Do not Duplicate Page 4 of 5
 Department Document No.
Focus & Rulz Pharmaceuticals (Pvt.) Ltd. Quality Control FR/ QCD/SAP/164
Effective Date Next Revision Date
Standard Analytical Procedure 01-04-2021 01-04-2024
M-Fer Oral Drops Revision Date Revision No.

26-03-2021 00
Prepared by: Sign with Date Reviewed by: Sign with Date Approved by: Sign with Date Authorized by: Sign with Date

Quality Control Analyst Quality Control Manager Quality Assurance Manager Plant Manager

b) Finished:
Shake well the bottle. Accurately take 10ml of the solution, equivalent to 100mg of iron in a
glass stopered flask. Dissolve in a mixture of 10ml of conc. HCl and 100ml Distilled water. Boil
for 15 seconds, cool, if not cooled will give false low assay. Add 2 g potassium Iodide. Allow to
stand for 20 minutes in dark area. Add 2ml of 1% starch solution and titrate with 0.1N Sodium
Thiosulphate solution until blue color disappears.
1ml of 0.1N Sodium Thiosulphate is equivalent to 5.585 mg of Iron.
7.3 Calculations
Calculate the results by following formula.
Volume used x Factor (5.585) x100
Wt. of Sample

7.4 Assay Limits

90.0 to 110.0% of the stated amount.

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