standard testing procedure artemether injection

 

standard testing procedure artemether injection

 

1.0 OBJECTIVE
1.1 To lay down a procedure for Analysis of Artemether injection.

2.0 SCOPE
2.1 This procedure is applicable to the Analysis of Artemether injection  in quality control laboratories

3.0 RESPONSIBILITY
3.1 Q.C- Chemist

4.0 ACCOUNTABILITY
4.1 Head-Quality Assurance



5.0 Identification: – 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: –
Injection comply with the test for Bacterial endotoxins as per SOP
12.0 Composition: –
Each ml contains:
Artemether I.P. 40 mg. 13.0Assay: – Limit: -NLT 90.0 % & NMT 110.0%
Method of Artemether: – by liquid chromatography.
Mobile phase: Acetonitrile: Water  62:38
Standard preparation: Weight Accurately about 40 mg working standard of Artemether diluted to 100 ml mobile phase.

Sample preparation: Taken 1.0 ml. sample Diluted to 100 ml volumetric flask with mobile phase.
Chromatographic condition:
Column 4.0 mm × 25 cm; 5 µm
Wavelength- 205 nm
Flow rate- 1.5 ml /mint.
Inj volume 20 µl.

Record the Chromatogram and measure the peak response of the measure peaks. Calculate the content of Artemether Respectively.

Calculation: –

Area of spl Wt. of std
…………… x …………… X 100X % Potency of Standard X 1
Area of std Wt. of spl

Procedure: – Inject Blank in single injection, Standard preparation in Replicates of three test preparation in duplicate injection.



System suitability: – % RSD of three replicate injections should not be more than 2.0

 

14.0    ABBREVIATION

 

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

  15.0      REFERENCE

Sr. No.           Reference Title
01                  IHS

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