This is due to the crystallization of the active ingredient—in this case, Testosterone. Certain “long” esters of Testosterone, such as Cypionate and Undecanoate, are more prone to crystallization.

During the production process, it’s crucial to include not only carrier oils but also additional compounds that enhance solubility and maintain sterile conditions. Elevated temperatures play a vital role in ensuring the active ingredient dissolves completely.

Crystallization is a common occurrence in pharmaceutical preparations. For example, medical instructions for products like Retabolil, Testosterone Cypionate, and Undecanoate specifically mention that if crystallization occurs, the ampoule should be gently heated until the inconsistencies are resolved.

A well-known pharmaceutical company conducted a detailed investigation on this issue and published an official report. Below are excerpts from their findings:

*”…The high concentration of active ingredients makes this product prone to crystallization when exposed to temperatures below the recommended range of 20°C to 25°C (68°F to 77°F). This characteristic is well-documented and explicitly addressed in the USPI and on the product label.

Potency tests from these batches confirm two critical product quality attributes:
1. When properly warmed and shaken, the crystals can be re-dissolved following the instructions provided in the product insert and on the vial label.
2. The potency of both retained and complaint samples confirms the product maintains its labeled strength (200 mg/mL).

Based on comprehensive testing and a thorough medical and safety evaluation, all distributed lots of Depo®-Testosterone 200 mg/mL remain suitable for use, even in the presence of crystals, provided they are prepared as directed in the product insert.”*

This confirms that crystallization does not compromise the product’s quality in any way—a conclusion supported by official investigations and verified by a qualified commission. It’s important to be aware of this!

However, if a product never crystallizes, regardless of temperature, it could be an indicator of aggressive solvents in its composition. These solvents are often used in cheaper products and can prevent crystallization even in cold conditions. Unfortunately, such solvents tend to irritate human tissue, increasing the risk of systemic inflammation and injection site pain. As responsible manufacturers, we avoid using such substances.

What Should You Do if Crystallization Occurs?

✅ Option 1: Place the vial in a container of hot water, shaking it occasionally, until the crystals dissolve.

✅ Option 2: Heat some water in your microwave, submerge the vial halfway, wait for 30 seconds, then shake. Repeat this process with slightly hotter water until the crystals disappear.

✅ Option 3: If water doesn’t work, place the vial on a pan and gently heat it. It may take 10–15 minutes to fully dissolve the crystals, as experience shows.

Our vials are made from heat-resistant medical glass, significantly reducing the risk of breakage from temperature changes. However, you should still avoid rapid temperature shifts.

⚠️ Important: Once the crystals have dissolved, allow the oil to cool to around 38°C before administering it.

Thank you for your attention and continued support!