Standard testing procedure of Iron Sucrose Injection


Standard testing procedure of Iron Sucrose Injection


1.1 To lay down a procedure for Analysis of Iron Sucrose Injection

2.1 This procedure is applicable to the Analysis of Iron Sucrose Injection . in QC lab

3.1 Q.C- Chemist

4.1 Head-Quality Assurance

5.0 Identification:
(A) Iron: – To 2.5 ml of injection add 17.5 ml of water and 5 ml of hydrochloric acid mix and heat for 5 minutes in a boiling water bath.

Cool and dropwise 13.5 N ammonium hydroxide until no further precipitation of ferric hydroxide occurs and filter wash

the precipitate with water to remove excess ammonium hydroxide, dissolve the precipitate in Aluminium volume

of 2 N hydrochloric acid, and add sufficient water to make a volume of 20 ml .to 3 ml of the solution so obtained

add 1 ml of potassium thiocyanate the resulting solution is red. To 1 ml of solution add 5 ml of amyl alcohol or

ethyl ether shake and allow to stand the organic layer is pink. To a separate 1 ml aliquot of solution add 2 ml of mercuric chloride the red colour is discharged iron (iii).

(B) Sucrose: – In the assay the principal peak in the chromatogram obtained with the test solution corresponds to the peak in the chromatogram obtained with the reference solution.

6.0 Description: Pour 10ml finish sample in Beaker and observed Visually.

7.0 pH: Taken 40ml sample in beaker the pH electrode first with purified water followed by sample dip the electrode in sample and observe the pH.

8.0 Extractable volume: Measured the volume by 10 ml Measuring cylinder and determine the volume.

9.0 Particulate matter: Injections that are solutions, when examine under suitable conditions of visibility are clear and practically free from particles that can be observed on visual inspection by the unaided eye.
10.0Sterility:-Injection comply with the test for sterility as per SOP

11.0 Bacterial endotoxins: – Not more than 3.7 USP Endotoxin per mg. of iron sucrose as per SOP

12.0 Composition: –
Each 5 ml contains:
Ferric hydroxide in complex with sucrose
Eq. to elemental iron 100 mg.

13.0 Assay: –

Method of Iron: – Determine by atomic absorption spectrophotometry.
Transfer about 350mg of ferrous ammonium sulfate, accurately weighed, to a 100ml volumetric flask add water to dissolve, dilute with water to volume and mix to obtain a solution having a concentration of about 50µg of iron per ml.
Transfer2.64g of calcium chloride to a 100ml volumetric flask add 500ml of water, and swirl to dissolve add 5.0ml to hydrochloride acid and dilute with water to volume.
To separate 50ml volumetric flasks transfer 2.0 ,4.0 ,6.0 ,8.0, and 10.0ml of iron stock solution dilute each flask with calcium chloride solution to volume and mix to obtain standard preparations having known concentration of about 2.0 ,4.0 ,6.0 ,8.0 and 10.0µg of iron per ml.

Sample preparation: -Take sample equivalent about 2.0 ml injection of 100 ml volumetric flask add 5 ml of hydrochloric acid until the solution turns yellow dilute with the calcium chloride further dilution 2.0 ml to 100 ml volumetric flask with calcium chloride.

Chromatographic condition: -Wavelength-248.3 nm with the suitable atomic absorption spectrophotometry.

14. Assay: –
Method of sucrose: – Determine by liquid chromatography.
Mobile phase: Acetonitrile: water.
79 : 21

Standard preparations— Dissolve an accurately weighed quantity of USP Sucrose RS in water, and quantitatively dilute with water to obtain solutions having known concentrations of about 13, 16, 18, 21, and 23 mg of sucrose per ml.

Sample preparation: -Transfer about 1.875 g of Injection, accurately weighed, into a 25-mL flask, add 1.25 mL of water, and mix. Add 1.25 mL of a monobasic sodium phosphate solution, prepared by dissolving 30 g in 50 mL, and mix. Allow the resulting solution to stand for 10 minutes to precipitate the colloidal ferric hydroxide. Dilute with water to volume, and mix. Centrifuge this solution at 3000 rpm for 15 minutes. Pass the resulting solution through a filter, discarding the first 2 mL of the filtrate.

Chromatographic condition: -The liquid chromatograph is equipped with a column compartment and a refractive index detector each maintained at a controlled temperature between 20 and 25 (±2) and a 4-mm × 25-cm column that contains packing L8. The flow rate is about 2.0 mL per minute. Chromatograph the Standard preparations, and measure the peak areas as directed for Procedure. The correlation coefficient obtained from the linear regression of the Standard preparations is not less than 0.998. [NOTE—The retention time for sucrose is about 8 minutes.


Sr. No. Abbreviation used Full form of abbreviation used
1.0 STP Standard Testing Procedure
2.0 QA Quality assurance
3.0 STD Standard
4.0 SPL Sample
5.0 NM Nano Meter


Analysis of vitamin B1 B6 B2 Nicotinamide and sodium pentothenate Injection

Analysis for Nandrolone Decanoate injection

Analysis of Dicyclomine and Diclofenac sodium Injection

standard testing procedure of Fexofenadine and Phenylephrine suspension

standard testing procedure of Piroxicam Injection

STP of Fungal Diastase and Papain capsules

standard testing procedure PVC

standard testing procedure glass ampoule

Standard testing procedure of Iron Sucrose Injection

Standard testing procedure lactose

Standard testing procedure mefenamic acid

standard testing procedure domperidone

standard testing procedure flavour mixed fruit

standard testing procedure dicyclomine hydrochloride

Standard testing procedure honey pure

standard testing procedure dextromethorphan hydrobromide

standard procedure of levocarnitine injection

Analysis of Ivermectin Suspension

standard testing procedure artemether injection

standard testing procedure artemether injection

standard testing procedure Carbocisteine syrup

standard testing procedure Phytomenadione injection

standard testing procedure serratiopeptidase

standard testing procedure starch IP

standard testing procedure sucrose refined sugar

standard testing procedure titanium dioxide

standard testing procedure tramadol hydrochloride

standard testing procedure zinc sulphate

standard testing procedure croscarmellose sodium

standard testing procedure colour erythrosine supra

standard testing procedure magnesium hydroxide

standard testing procedure diclofenac sodium

standard testing procedure dibasic calcium phosphate

standard testing procedure cyanocobalamin

standard testing procedure cholecalciferol

standard testing procedure Calcium carbonate oyster shell powder

standard test procedure Calcium Citrate

standard testing procedure Bronopol

standard testing procedure Bromhexine Hydrochloride

Standard Testing Procedure diclofenac sodium injection

Standard Testing Procedure Drotaverine Hydrochloride injection

Standard Testing Procedure Tranexamic acid injection

standard test procedure paracetamol infusion

standard test procedure ofloxacin and ornidazole infusion

standard test procedure ornidazole injection

standard test procedure Ondansetron injection

standard test procedure dextrose injection

standard test procedure ciprofloxacin injection

STP and analysis method of Ammonium Chloride

Analysis method of aceclofenac

Sop for Analysis of cartons

analysis method of Losartan Potassium and Hydrochlorothiazide

analysis method of Linezolid Dry Syrup

analysis method of Drotaverine Hydrochloride and Mefenamic acid

Analysis method of Ceftriaxone Sodium and Sulbactam sodium Injection

analysis method of Cefepime and Tazobactam Injection

 Analysis method of Hydroquinone Cream

 Analysis method of Tacrolimus Ointment

 Analysis method of Terbinafine HCL Cream

 Analysis method of Mometasone Furoate and Fusidic Acid Cream

 Analysis method of Disodium Hydrogen Citrate Syrup

Analysis method of Hydroquinone with Tretinoin Cream

 Analysis method of Hydroquinone Tretinoin and Mometasone Furoate Cream

 Analysis method of Sertaconazole Nitrate Cream

 Analysis method of Halobetasol Propionate Cream

 Analysis method of Povidone Iodine with Ornidazole Ointment

Analysis method of Eberconazole Cream

 Analysis method of Luliconazole Cream

 Analysis method of Fluconazole Gel

Analysis method of Ketoconazole Cream

Analysis method of Salbutamol and Choline theophyllinate Syrup

Analysis method of Methylcobalamin Injection

Analysis method of Piroxicam and paracetamol Injection

Analysis method of Alpha Beta Arteether Injection

Analysis method of Enrofloxacin Suspension

Analysis method of Levetiracetam Syrup

Analysis method of Sucralfate suspension

Analysis method of Sucralfate and Oxetacaine Suspension

Analysis method of Quinine Sulphate Suspension

Analysis method of Calcium Carbonate vitamin D3 Zinc Gluconate and Magnesium hydroxide suspension

Analysis method of Suspension of Tribasic Calcium phosphate with vitamin D3 and Vitamin B12

Analysis method of Calcitriol with calcium citrate Suspension

Analysis method of Oxyclozanide and Fenbendazole Suspension

Analysis method of Oxyclozanide and Levamisole Suspension

Analysis method of Triclabendazole and Ivermectin Suspension

Analysis method of Itraconazole Solution

Analysis method of Levocetirizine Dihydrochloride syrup

Analysis method of Iron Calcium Vitamin D3 Folic Acid Vitamin B12 Suspension

Analysis method of Ferrous Ascorbate Cyanocobalamin and Folic Acid Suspension

Analysis method of Ambroxol Hydrochloride Drops 

Analysis method of Dried Aluminium Hydroxide Magnesium Hydroxide Oxetacaine and Simethicone suspension

Analysis method of Ferrous Ascorbate with Folic Acid suspension

Analysis method of Piracetam Syrup

Analysis method of Rafoxanide and Levamisole suspension

Analysis method of Zinc gluconate Syrup

Analysis method of Magaldrate Simethicone and Oxetacaine suspension

Analysis method of mefenamic acid and paracetamol suspension

Analysis method of Cholecalciferol Drops

Analysis method of Racecadotril suspension

Analysis method of Deflazacort Suspension

Analysis method of Montelukast sodium and levocetirizine Dihydrochloride Syrup

Analysis method of Iron and Folic Acid Syrup

Analysis method of Cyproheptadine Hydrochloride and Tricholine Citrate Syrup

Analysis method of Paracetamol Phenylephrine hydrochloride and Chlorpheniramine Maleate in oral liquid

Analysis method of Levofloxacin Hemihydrate Ornidazole and Vitamin E Solution

Analysis method of Albendazole and ivermectin in oral liquid

Leave a Comment

error: Content is protected !!