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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