KP — third-party testing record
The third-party reports the Institute examined, what each determined, and the provenance of each sample.
The Institute assesses documentation, not product. It has purchased nothing, tested nothing and inspected nothing. Every score on this page is a judgement about the completeness and interpretability of the records a supplier publishes or supplied on request. A high score means that a supplier documents its material well. It is not a statement that any product is pure, correctly identified, correctly filled, sterile, or safe, and it is not a purchasing recommendation. The Institute makes no purchasing recommendations.
§3Third-party testing record
The Institute records the third-party reports it has been able to obtain for this supplier, what each determined, and what each left undetermined. It has commissioned none of these reports and has not verified that the material tested is representative of the material supplied. Where a report was supplied by the supplier rather than obtained independently, the sample was chosen by the party being assessed, which is recorded at §3.2.
§3.1Reports examined
Table 1. Third-party analytical reports examined for KP, with the determinations each carried. Empty cells record a determination that was not made or not reported, not a failure.
| Report date | Compound | Purity, % area | Identity method | Content | Water | Counter-ion | Batch link |
|---|---|---|---|---|---|---|---|
| 28 Jun 2024 | Teduglutide | 95.70 | ESI-MS, deconvoluted average mass | 83.6 % | 4.5 % | 5.3 % | Traceable |
| 02 Jun 2024 | Tesamorelin | 96.87 | ESI-MS, deconvoluted average mass | 81.9 % | 7.0 % | 11.3 % | Traceable |
| 01 Jun 2024 | Danuglipron | 97.73 | ESI-MS, deconvoluted average mass | 86.0 % | 5.3 % | 10.3 % | Traceable |
| 08 Apr 2024 | Mazdutide | 97.63 | ESI-MS, deconvoluted average mass | 84.0 % | 4.3 % | 8.6 % | Traceable |
| 20 Mar 2024 | Survodutide | 99.80 | ESI-MS, deconvoluted average mass | 81.0 % | 6.8 % | 4.5 % | Traceable |
| 09 Feb 2024 | Exenatide | 98.69 | ESI-MS, deconvoluted average mass | 85.7 % | 4.4 % | 7.3 % | Traceable |
| 14 Nov 2023 | Dulaglutide | 98.68 | ESI-MS, deconvoluted average mass | 76.5 % | 4.6 % | 11.6 % | Traceable |
| 06 Nov 2023 | Orforglipron | 99.35 | ESI-MS, deconvoluted average mass | 80.9 % | 6.8 % | 6.1 % | Traceable |
| 30 Oct 2023 | Survodutide | 97.97 | ESI-MS, deconvoluted average mass | 90.6 % | 2.1 % | 10.1 % | Traceable |
| 08 Aug 2023 | Lixisenatide | 97.97 | ESI-MS, deconvoluted average mass | 83.7 % | 1.9 % | 9.9 % | Traceable |
| 23 Jul 2023 | Maridebart cafraglutide | 98.67 | ESI-MS, deconvoluted average mass | 82.8 % | 4.5 % | 10.3 % | Traceable |
| 16 Jul 2023 | Danuglipron | 99.80 | ESI-MS, deconvoluted average mass | 83.7 % | 3.0 % | 6.4 % | Traceable |
| 11 Apr 2023 | Liraglutide | 99.80 | ESI-MS, deconvoluted average mass | 79.6 % | 4.1 % | 7.7 % | Traceable |
| 11 Apr 2023 | Lixisenatide | 96.93 | ESI-MS, deconvoluted average mass | 81.2 % | 7.7 % | 7.9 % | Traceable |
| 03 Apr 2023 | Retatrutide | 96.65 | ESI-MS, deconvoluted average mass | 76.9 % | 4.4 % | 9.2 % | Traceable |
| 22 Mar 2023 | Sermorelin | 97.92 | ESI-MS, deconvoluted average mass | 87.5 % | 4.0 % | 7.3 % | Traceable |
| 13 Feb 2023 | Orforglipron | 97.27 | ESI-MS, deconvoluted average mass | 86.4 % | 2.0 % | 6.7 % | Traceable |
| 17 Dec 2022 | Ecnoglutide | 98.40 | ESI-MS, deconvoluted average mass | 85.0 % | 3.7 % | 9.4 % | Traceable |
| 18 reports examined. A purity figure without a named method indicates that chromatography was performed and little more; 0 of these reports carry no content determination and therefore do not permit a mass balance to be formed. | |||||||
§3.2Provenance of the tested samples
Table 2. Provenance of the samples underlying the reports above. Sample provenance determines what a report can support.
| Provenance | Reports | What it supports |
|---|---|---|
| Supplier-selected | 13 | The supplier chose which material to submit. A favourable result establishes that the supplier can produce material of that quality, and not that a given order will be of that quality. |
| Independently purchased | 3 | The stronger class of evidence. Establishes what an ordinary purchaser received on one occasion. |
| Provenance not recorded | 2 | Cannot be placed in either class, and the Institute treats it as the weaker. |
| Provenance counts are the Institute’s classification of the reports it examined and are not published figures of any supplier. | ||
References cited on this page
References are numbered in order of first citation in this document. Each superscript in the text links to its entry below.
- Sodhi M, Rezaeianzadeh R, Kezouh A, Etminan M. Risk of gastrointestinal adverse events associated with glucagon-like peptide-1 receptor agonists for weight loss. JAMA 2023;330(18):1795–1797. doi:10.1001/jama.2023.19574 · PMID 37796527
- United States Pharmacopeial Convention. General Chapter ⟨1225⟩ Validation of Compendial Procedures. United States Pharmacopeia — National Formulary (USP–NF) 2024;USP 2024 Issue 1. identifier not held by the Institute
Identifiers are reproduced only where the Institute holds them. Where a digital object identifier or PubMed identifier is not shown, the Institute has recorded the journal and year and has not constructed an identifier.