Egrifta (Tesamorelin) Compounding Pharmacy: How to Read a Certificate of Analysis

What a Certificate of Analysis Is

A certificate of analysis is a testing laboratory's report on one lot. Depending on the laboratory, it may report an identity result, a purity result and the method behind it, sterility and endotoxin results, the specification each result was compared against, and a lot number tying the report to the vial. Only the tests actually printed on the certificate were performed for that report.

Where Tesamorelin Sits

Tesamorelin is the active ingredient in Egrifta, approved November 10, 2010 under BLA 022505 [3]. Egrifta SV is a 2 mg vial dosed at 1.4 mg once daily; Egrifta WR is an 11.6 mg vial dosed at 1.28 mg once daily. The labels state the two are not substitutable [2][4]. The only approved use is reduction of excess abdominal fat in HIV-infected adults with lipodystrophy [2].

FDA has made no category-based statement about compounding tesamorelin: it is not on FDA's list of bulk substances that may present significant safety risks, and it appears in no category of FDA's list for state-licensed pharmacies and physicians or of its list for outsourcing facilities [5][6][7]. It is also not among the six peptides in HHS's draft enforcement-discretion policy filed October 28, 2026 [8].

Reading Each Line

Identity. The certificate should name tesamorelin acetate rather than just "peptide". The FDA label describes tesamorelin as a 44-amino-acid GHRF analog with a molecular weight of about 5,135.9 Da [2]. Read the identity line together with the result and method the certificate itself states.

Purity. Read any purity percentage together with the named method and the specification printed on the same document. A percentage alone does not say what was measured.

Sterility and endotoxin. A certificate may report sterility and endotoxin results. Those results describe the tested lot; they do not establish FDA approval.

Strength and lot. The strength on the certificate should match the vial and the prescription. For reference, the labeled 1.4 mg dose comes from the 2 mg SV vial and the 1.28 mg dose from the 11.6 mg WR vial [2][4]. The lot number on the certificate should be the number printed on the vial.

What the Certificate Cannot Tell You

A certificate does not describe how a product behaves in the body. For the original Egrifta 1 mg/vial product, the label reports anti-tesamorelin IgG antibodies in 50% of patients at 26 weeks and 47% at 52 weeks; 85% of those with hypersensitivity reactions had antibodies, and fat loss and IGF-1 response were similar with or without antibodies [2].

A 2007 randomized trial of 412 HIV-infected adults found that tesamorelin 2 mg daily for 26 weeks reduced visceral adipose tissue by 15.2% while it rose 5.0% on placebo (P<0.001) [9]. That trial used 2 mg daily of the original 1 mg/vial product, not either currently labeled dose [2][9]. It tested the approved drug, not a compounded product.