James Alexander Corporation

FAQ

Do you sell components (including empty crushable glass ampoules)?

No, we don’t sell components. We have been a custom filler for over 35 years and would be happy to fill your product.

At what temperature and for how long is Amyl Nitrite stable out of the refrigerator?

James Alexander has stability data to support a 3 year expiration date at 36-46 degrees F. This data allows for shipment of product to our customer at uncontrolled temps and during the filling and further packaging processing the product is stored at room temperature for up to 16 hours at a time. Exposure to conditions other than those listed on the product packaging will adversely affect the stability of the product.

Can we get more than one use out of your packages?

All of our packaging is unit-dose.

How do I dispose of expired Ammonia Inhalants and Amyl Nitrite?

Every state law is different. Please consult your local DEP office. If you need the SDS for the product, they are readily available on our website.

What are your minimum runs?

Our minimum runs are 25,000 pieces. We do offer samples runs of 200 pieces so you can test your product for compatibility and stability in our packaging. Call for details.

Do you have an in-house lab for testing?

We do minimal testing in house. We have been working with an excellent FDA-registered outside lab for over 25 years whom we could recommend if necessary.

Do you fill Hazardous Materials?

Yes, we fill hazardous materials on a regular basis.

Are you ISO-Certified or do you have a clean room?

No, but we do follow CGMPs & QSR Regulations and are routinely audited by the FDA. We do have a production area that is environmentally monitored.

Do you do sterilization in house?

We can autoclave glass ampoules in house.

Do you fill powders?

Yes, we can fill powders, if they flow freely and do not clump. We can’t fill a lyophilized powder.

Do you offer a 2-part system?

Yes, our DuoDispersion System® is available in a dropper tip or swab version.
DuoDispersion System High Res (1)