Greetings, gentlemen! 💪
A big thank you to our client who posed a query about crystallization, inspiring the conception of this article. We trust that the information provided will prove beneficial! 😎
While quite uncommon, there are instances where vials may exhibit inconsistencies in the oil, or even the presence of a solid layer floating atop it.
In this specific scenario, the crystallization phenomenon is attributed to the active ingredient, Testosterone, particularly in the “long” esters such as Cypionate and Undecanoate, which display a propensity for crystallization.
The formulation process involves not only the inclusion of carrier oil but also the addition of substances that enhance solubility and sterile properties. Subsequently, elevated temperatures facilitate the complete dissolution of the active substance.
It is evident, therefore, that reducing the temperature can potentially induce product crystallization. Although this occurrence is infrequent with our products, it remains a possibility.
Crystallization is a common occurrence in pharmaceutical preparations. The medical instructions for Retabolil, Testosterone Cypionate, and Undecanoate explicitly state that in the event of crystallization, the ampoule should be heated until the inconsistencies disappear.
Pfizer conducted an independent investigation and released a report, from which we present excerpts below. The full version of the report is also linked here.
“…The high concentration of active ingredients makes the product highly prone to crystallization when exposed to temperatures lower than those recommended on the label [20°C to 25°C (68°F to 77°F)]. This characteristic is well-documented and is explicitly addressed in instructions found in both the USPI and on the product vial label.
Potency testing from these lots confirms two critical product quality attributes:
🔴 The product can be warmed, shaken, and the crystals re-dissolved when prepared according to the instructions in the product insert and on the vial label; and,
🔴 The potency of the retained and complaint samples confirms product potency at the labeled strength (200 mg/mL). Based on our testing and a medical and safety evaluation, all distributed lots of Depo®-Testosterone 200 mg/mL remain suitable for use, regardless of the presence of crystals, when used as directed in the product insert.”
❗️Thus, crystallization does not compromise the quality of the product, as officially investigated and confirmed by a qualified commission. It’s crucial to be aware of this!
Additionally, it’s worth noting that the absence of crystallization at any temperature may not be ideal. In products containing aggressive solvents (often found in cheaper products), crystallization may not occur even in cold temperatures. However, this can make the liquid more irritating to human tissues, leading to potential systemic inflammation and post-injection pain (PIPs). As responsible manufacturers, we avoid this.
So, what should you do? 🤔
✅ In the event of crystallization, place the vial in a container of hot water, shaking occasionally, until the crystals dissolve.In the event of crystallization, place the vial in a container of hot water, shaking occasionally, until the crystals dissolve.
✅ Warm some water in your microwave. Submerge the vial halfway in the hot water, wait 30 seconds, shake the vial a little, and repeat with hotter water until the crystals disappear.
If water doesn’t help dissolve the crystals, then:
✅ Place the vial on a pan and slowly heat it until the crystals completely dissolve. As practical experience suggests, this process may take up to 10-15 minutes.
Even though we use heat-resistant medical glass, the likelihood of the vial bursting due to temperature changes is very low. However, abrupt temperature changes should be avoided.
❗️Important: After this process, the oil must be cooled to a temperature of 38 degrees before injection.
Thank you for your attention and support, Gentlemen!
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