Analysis for Nandrolone Decanoate injection
1.0 OBJECTIVE
1.1 To lay down a procedure for Analysis of Nandrolone Decanoate injection
2.0 SCOPE
2.1 This procedure is applicable to the Analysis of Nandrolone Decanoate injection.in QC lab
3.0 RESPONSIBILITY
3.1 Q.C- Chemist
4.0 ACCOUNTABILITY
4.1 Head-Quality Assurance
5.0 Identification: Determine by thin layer chromatography.
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:
Nandrolone deaconate I.P. 25 mg./50 mg.
13.0 Assay: NLT 90.0% and NMT 110.0%
Method of Nandrolone deaconate: Determine by liquid chromatography.
Mobile phase: Water: Methanol
10 : 90
Standard preparation: Weight accurately about 50 mg Working standard. of Nandrolone Deaconate 100 ml of Methanol.
Sample preparation: Take equivalent to 50 mg of sample Dilute 100 ml of Methanol.
Chromatographic condition: –
Wavelength-240 nm
Flow rate 1.0 ml /mint.
Injection volume- 10 micro liter.
Column- C18 250cm x 4.6 mm 5µm.
Column temp. 500C
Retention time about 4.5 mint.
Calculation:
Area of spl Wt. of std
………………… X……………………. X 100 X % Potency of Standard
Area of std Wt. of spl
Record the Chromatogram and measure the peak response of the measure peaks. Calculate the content of Nandrolone Deaconate Respectively.
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
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