Standard Testing Procedure Tranexamic acid injection

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

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

4.0 ACCOUNTABILITY
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.

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.

Standard Testing Procedure Tranexamic acid injection

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