Help! Test E Changed Colors

Pharma
1

So I heated one of my bottles of test e in the oven at 300 deg F for 30 min to sterilize it and then vented it with a pin for a couple seconds. That was a few days ago and the test solution has stilil not returned to its original color.

The picture below shows the bottle on the left which has been baked in the oven and the bottle on the right is what it looked like before I baked it.

Is this anything to be worried about? The only thing I was thinking is that maybe part of the rubber stopper melted when I was baking it and seeped into the test solution? The second pic shows what the rubber stopper looks like to give you an idea if it would be even possible for it to melt.

2

May I ask why you heated the bottle instead of filtering the contents? I would’ve thought a .22 would do the job.

3

heating just seemed easier then having to remove the rubber stopper, get a new vial, buy a filter, etc.

4

Heating will not sterilize it btw. Filtering will sterilze though. But hey if it means saving $4 dollars in supplies then why not take shortcuts? amirite?

edited

5

Just my opinion, but I would not shoot that…

6

[quote]BONEZ217 wrote:
Heating will not sterilize it btw. Filtering will sterilze though. But hey if it means saving $4 dollars in supplies then why not take shortcuts? amirite?

edited[/quote]

Oh really?

"DRY HEAT STERILIZATION OF PARENTERAL OIL VEHICLES.

T Kupiec1 , R Ahmad2 , P Matthews3 , L V Allen, Jr.4

1Analytical Research Laboratories, Edmond, OK, 2University of Central Oklahoma, Edmond, OK, 3Analytical Research Laboratories, Edmond, OK, 4Midwest Institute of Research and Technology, Edmond, OK,

Purpose.
The purpose of this study was to evaluate the effect of temperature and time on the dry heat sterilization conditions of three different parenteral oil vehicles.

Methods. Three different oils, cottonseed oil, peanut oil, and sesame seed oil were each spiked with Bacillus subtillus spores. The inoculated oils were exposed to dry heat at 4 different temperatures (150ºC, 160ºC, 170ºC, and 180ºC) for three time intervals (1, 1.5 and 2 hours).

Following inoculation and dry heat sterilization, samples were placed in a sterile laminar flow hood and processed according to <71> Sterility Tests of the USP XXIII using thioglycolate broth and fluid D. The specimens were then placed into the incubator at 30ºC for 3, 5 and 7 days and observed for bacterial growth. The above variables were performed in triplicate. Positive and negative controls were run along with each variable and group for quality control.

Results. Cottonseed oil, peanut oil, and sesame seed oil were found to be free of Bacillus subtillus following dry heat sterilization at all four temperatures for 1, 1.5 and 2 hours at 3, 5 and 7 days. The positive controls were positive for observed growth and the negative controls had no observed bacterial growth.

Conclusions. Dry heat sterilization of parenteral oils at 150ºC for one hour was sufficient time and temperature. However the authors recommend dry heat sterilization at 160ºC for one hour after the oil has reached the desired temperature. These studies were partially funded by the Professional Compounding Centers of America, Inc."

http://www.aapsj.org/abstracts/AM_1999/973.htm

7

Now post up a study that shows how you sticking the vial in the oven will get rid of particle contaminants.

8

Cool study. I hope it relates to your 30 min run through your oven. What kind of bacteria was in your vials, if you dont mind sharing?

Even if the bacteria die from the heat. Whats the plan for the dead bacteria cells floating in the liquid?

Im picking on little things simply to point out that filtering is more effective at all aspects of creating a clean high quality product for IM injection.

9

[quote]BONEZ217 wrote:
Cool study. I hope it relates to your 30 min run through your oven. What kind of bacteria was in your vials, if you dont mind sharing?

Even if the bacteria die from the heat. Whats the plan for the dead bacteria cells floating in the liquid?

Im picking on little things simply to point out that filtering is more effective at all aspects of creating a clean high quality product for IM injection. [/quote]

Ok thanks for the advice bro. Not trying to start an argument.

I guess my real question is do you think its still okay to use that vial thats been baked and the color changed?

Thanks

10

The color change could be from oxidation. Maybe the oil burned. It’s kind of hard to say what actually happened.

If I was confident it was sterile Id probably try it out. If it’s sterile the worst case is that the product is less potent. It’s unlikely that the active drug is completely destroyed.