PT-141 (Bremelanotide) Compounding Pharmacy: How to Read a Certificate of Analysis

What to check on the certificate

A certificate of analysis carries no approval, and for a compounded peptide there is none to carry: compounded drugs are not FDA-approved and are not reviewed by FDA for safety, effectiveness or quality before they reach patients [3]. A certificate is therefore only as informative as the details it shows. These are the points worth checking:

• Material: the certificate names bremelanotide (PT-141) and not a different compound.
• Lot: the lot number on the certificate matches the lot on the product you hold.
• Tests reported: which tests were run, such as identity, purity, sterility or endotoxin, and which are absent.
• Results against specification: each result sits next to a specification, and the result meets it. A number with no specification beside it cannot be judged.
• Laboratory and date: the testing laboratory is named, and the test date is stated.

PT-141 is a peptide name, not a product approval

Bremelanotide is approved as Vyleesi, a 1.75 mg subcutaneous autoinjector (NDA 210557, approved June 21, 2019) [2][4]. The approved use is premenopausal women with acquired, generalized hypoactive sexual desire disorder: low desire causing marked distress or interpersonal difficulty that is not due to another medical or psychiatric condition, relationship problems, or a medication [2]. The label states it is not indicated for postmenopausal women or for men, and not to enhance sexual performance [2]. Compounded and research-use products sold as PT-141 are not Vyleesi and are not FDA-approved drugs [1].

Bulk-substance lists and what they do not show

Bremelanotide is not on FDA's list of bulk substances that may present significant safety risks, and it is not one of the six peptides in HHS's October 2026 draft enforcement-discretion policy [5][6][7]. Those facts alone do not establish whether a particular compounded bremelanotide product is permitted, and they say nothing about the quality of any lot.

What the Vyleesi label says about the drug itself

The label gives a dose of 1.75 mg subcutaneously into the abdomen or thigh, as needed, at least 45 minutes before anticipated sexual activity. It says no more than one dose in 24 hours, says more than 8 doses a month is not recommended, and says to stop after 8 weeks if there is no improvement in symptoms [2].

In the pooled phase 3 trials of 1,247 premenopausal women, nausea occurred in 40.0% on Vyleesi versus 1.3% on placebo, flushing in 20.3% versus 0.3%, injection site reactions in 13.2% versus 8.4%, and headache in 11.3% versus 1.9% [2]. Each dose transiently raises blood pressure and lowers heart rate. The label reports maximal increases of 6 mmHg systolic and 3 mmHg diastolic, peaking 2 to 4 hours after the dose, with heart rate down up to 5 beats per minute, usually back to baseline within 12 hours [2]. In an ambulatory study of 127 women dosed daily for 8 days, the mean daytime increase was 1.9 mmHg systolic and 1.7 mmHg diastolic, with mean heart rate down 0.5 beats per minute [2]. The label lists uncontrolled hypertension and known cardiovascular disease as contraindications [2].