Product Sourcing, Testing, and Quality Standards

We maintain a rigorously tested and diversified supply chain across the United States. Our FDA Regulated Facilities are held to strict quality protocols and contractual obligations. Any product that fails to meet our standards is rejected, and the supplier is required to issue a refund.

Our raw material suppliers operate in FDA-registered, inspected, and audited facilities located in the United States. These facilities are manufactured under strict current Good Manufacturing Practices (cGMP).

We exclusively partner with FDA-audited and ISO-certified analytical laboratories based in the United States.
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Janoshik Analytical
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The industry norm typically includes just two tests: purity and quantity via High Performance Liquid Chromatography (HPLC). Some providers may substitute Mass Spectrometry, which provides similar results using different analytical techniques.

We exceed these standards by conducting five distinct tests, applied twice—first when raw materials arrive, and again after final product completion:

Aseptic filtration (sterile processing) may slightly reduce purity levels due to mechanical handling.

Endotoxins are toxic substances found in the outer membrane of certain bacteria (Gram-negative). These molecules, known as lipopolysaccharides (LPS), can enter solutions when bacteria grow or die, potentially triggering harmful immune responses.

Because endotoxins are invisible and resistant to heat, products intended for injection are required to meet strict testing standards.

Endotoxin limits vary depending on usage, but we set a strict internal threshold of no more than 20 EU per mL. This aligns with the most stringent levels recommended by USP <85>, EP 2.6.14, JP 4.01, and FDA guidance.

Sterility testing is essential to confirm that no microorganisms—bacteria, fungi, or others—are present in the final solution. We follow USP <71> standards to validate sterility in applicable products.

Elemental impurities, or heavy metals, are regulated under U.S. standards. We are currently developing a comprehensive pass/fail testing protocol for six key heavy metals:

While not all current products include this testing, we are on track to implement full coverage across our portfolio by the end of 2025.

We work with contract manufacturers in the United States for finished product production.

For lyophilized (freeze-dried) peptides, we require aseptic processing, including sterile filtration through 0.22 µm filters in GMP-compliant facilities prior to freeze-drying. Sterility is confirmed through USP <71> testing.

We maintain our high analytical standard—five distinct tests per product—far exceeding industry norms:

Each finished product is batch-coded and labeled with a QR code that links to its Certificate of Analysis and expiration date. Quality and consistency are carefully tracked to ensure reliability.