Standard Testing Procedure Tranexamic acid injection


Standard Testing Procedure Tranexamic acid injection



1.1 To lay down a procedure for Analysis of Tranexamic acid injection (1ml)

2.1 This procedure is applicable to the Analysis of Tranexamic acid (1ml) in quality control
3.1 Q.C- Chemist

4.1 Head-Quality Assurance

5.0 Identification: To a volume containing 400 mg of Tranexamic acid, add 2 ml of ether, stir, add 5 ml methanol, stir again and allow

to crystalline. The crystals, after drying comply with the following test.
(A) Determine by I.R
(B) To 1ml of a 1 per w/v solution, add 1 ml of a 0.2 per cent w/v solution of Ninhydrine in ethanol and heat on water bath for 2 minute, a dark bluish violet colour is produced.

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: –
NMT 35 Endotoxins unit/ml of Ondansetron as per SOP

12.0 Related substance: Determine by liquid chromatography.
Test solution: -Dilute the injection containing 1.0% w/v Tranexamic acid with water.
Reference solution (a) A 0.01 % w/v solution of the Tranexamic acid RS in water.

Reference solution (b) A 0.001 % w/v solution ml of ml 4-aminomethylbenzoic acid in water.
Mobile phase: – A mixture of a solution containing 11.0gm of anhydrous sodium dihydrogen orthophosphate in 500 ml of water,

add 5 ml of triethylamine and 1.4 gm. of sodium dodecyl sulphate, adjusted to pH 2.5 with 2M Orthophoshoric acid and

dilute to 600 ml with water and 400 volumes of methanol.

Chromatographic condition: –
Wavelength-220 nm
Flow rate 0.9 ml /mint.
Injection volume- 20 µl.
Column- C18 25cm x 4.6 mm 5µm bonded to porous silica
Inject reference solution(a) the test is not valid unless the column efficiency is not less than 2000 theoretical plates and the tailing factor is not more than 2.0.

1) Tranexamic acid Impurity A- Not more than 0.1%
2) Tranexamic acid Impurity B – Not more than 0.2%
3) Any secondary peak – Not more than 0.1%
4) Total impurities- Not more than 0.2%

13.0 Composition: –
Each 5 ml contains:
Tranexamic acid I.P. 500 mg.

14.0 Assay: –    NLT 95.0% and NMT 105.0%

By Titration method:
To a volume containing 100 mg of Tranexamic acid, add 50 ml of water and adjust to pH 7.0 with sodium hydroxide or 0.1 M Hydrochloric acid.

Add 25 ml of formaldehyde solution, previously adjusted to pH 7.0 and 20 ml of sodium hydroxide and titrate with 0.1 M Hydrochloric acid

determining the end point potentiomertrically carry out a blank titration.
1ml of 0.1 M sodium hydroxide is equivalent to 15.72 mg of C8H15NO2.

Calculation: –

V= Volume (in ml) of Tranexamic acid Solution consumed in titration.
N = Actual normality of Hydrochloric acid.


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


Sr. No.           Reference Title
01 I.P.

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 !!