BACTERIAL ENDOTOXIN TEST FOR DEXAMETHASONE INJECTION
1.0 EQUIPMENT REQUIRED
LAF, Heating Block, Cyclo Mixer, Micropipettes,
2.0 MATERIAL REQUIRED
Depyrogenated dilution tube 13mm X 100mm,
Depyrogenated assay tube 12mm X 75mm,
Individually packed Sterile, Endotoxin free micropipette tips.
3.1 Clean all the required glassware and dehydrogenated all the glassware.
3.2 Transfer all the dehydrogenated all the glassware to BET room.
3.3 Switch on the heating block and set the temperature at 37°C.
4.0 Calculation Of Maximum Valid Dilution and preparation of product dilution to MVD/2.
4.1 Product will be tested at MVD.
4.2 Calculate MVD for sample specimen by following formula –
For this take 100 µl of sample and add to it 900 µl LRW & mix for three minutes using vortex mixer. Now take 100 µl from last dilution and add to it 68 µl LRW. this will be the product diluted to MVD/2.
5.0 Preparation of Control Standard Endotoxin (CSE)
5.1 Reconstitute CSE in LRW as per manufacturers instruction as laid down in the bottle and
certificate supplied by manufacturer, and vortex for 30 minutes intermittently.
5.2 Use Reconstituted CSE within 4 weeks after reconstitutions. Store reconstituted CSE at 20C to 80C temperature.
5.3 Prepare a CSE dilution with LRW to yield 1EU/ml and shake the dilution on vortex for 3 minutes. Prepare 4 CSE by diluting a volume from 1 EU/ml CSE with LRW. For this take 200 µl of 1 EU/ml CSE and add to it 200 µl LRW. This will be 4 CSE.
5.4 Shake the dilution on vortex mixer for 3 minutes.
6.0 Reconstitution of Lysate
6.1 Now reconstitute the Lysate by opening the aluminum seal of Lysate with the help of sterile blade.
6.2 Collect Lysate powder into the bottom of the vial by tapping on a hard surface. And then open the cork slowly.
6.3 As per manufacturer’s instruction, add LRW or buffer solution before use and replace the cork immediately.
7.0 Test Procedure
7.1 Prepare solutions A, B, C and D as shown in Table 1,
||LRW in ml
||4l (CSE) in ml
||Product at MVD/2 in ml
||Lysate in ml
||No. of Replicates
||Negative product control (NPC)
||Positive Product control (PPC)
||Positive water control (PWC)
||Negative water control (NWC)
- Take 8 dehydrogenated4ererer assay tubes and label the tubes by numbering and arrange in stand one opposite to each other. i.e. 1 & 2 for NPC, 3 & 4 for PPC, 5 & 6 for PWC, 7 & 8 for Negative water control.
- Add 50ml of LRW in NPC and PWC, and 100 ml in NWC. Immediately add 50 ml of product sample, which is diluted at MVD/2 in a NPC and PPC, and then add 50ml of CSE that is diluted to 4l in a PPC and PWC.
- Finally add 100ml of Lysate in all tubes and next, mix the assay tubes by hand and incubate in heating block, where the temperature is maintained at 37 ± 10C for 60 ± 2
- Interpretation of Result
- Each tube in the gel clot method is interpreted as either positive or negative, Positive test indicates the formation of firm gel capable of maintaining its integrity when the test tube is inverted 1800.
- A negative test is characterized by the absence of gel or by the formation of a viscous mass, which does not hold when the tube is inverted at 1800.
- The test is not valid if the positive product control is negative or if the negative control is
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