AOD-9604 — supply and evidence gaps
Suppliers in the assessment set, what a certificate for this compound must carry, and the numbered record of what has not been established.
§8Supply and quality considerations
§8.1Suppliers in the assessment set
16 of the 20 suppliers in the Institute's assessment set list a line in this compound class. Supplier domains are reproduced as plain text and are not linked; reproducing a domain is a matter of record, and linking to it is an act of referral the Institute does not make.
Table 8. Suppliers in the assessment set carrying a line in this class, with their certificate-completeness and third-party-evidence scores from the supplier evaluation rubric.
| Supplier | Code | Domain | City | Certificate | Third-party |
|---|---|---|---|---|---|
| Xi'an Mokemei Biotechnology Co., Ltd. | MKM | mokemeibiotechnology.com | Xi'an | 4 / 5 | 5 / 5 |
| ChinaPeptides Co., Ltd. (QYAOBIO) | QYB | qyaobiopeptides.com | Shanghai | 5 / 5 | 5 / 5 |
| Sangon Biotech (Shanghai) Co., Ltd. | SGN | sangonbio.com | Shanghai | 5 / 5 | 5 / 5 |
| Chinese Peptide Company Co., Ltd. | CPC | chinesepeptidecompany.net | Hangzhou | 4 / 5 | 4 / 5 |
| Shanghai Sigma-Audley New Material Technology Co., Ltd. | SSA | shanghaisigmaaudley.com | Shanghai | 4 / 5 | 4 / 5 |
| Hunan Aslsen Technology Co., Ltd. | Homopeptide | homopeptide.net | Changsha | 5 / 5 | 5 / 5 |
| Tianjin Finder Chemical Co., Ltd. | TFC | tfcpeptides.com | Tianjin | 5 / 5 | 4 / 5 |
| Flourishglobal Peptide Biotech (Chengdu) Co., Ltd. | FGP | flourishglobalpeptide.net | Chengdu | 3 / 5 | 4 / 5 |
| Qingdao Sigma Chemical Co., Ltd. | QSC | qingdaosigma.com | Qingdao | 4 / 5 | 4 / 5 |
| Shanghai Wibson Biotechnology Co., Ltd. | SWB | shanghaiwibsonbiotechnology.net | Shanghai | 5 / 5 | 5 / 5 |
| Nantong Guangyuan Chemical Co., Ltd. | GGPeps | ggpeps.net | Nantong | 3 / 5 | 4 / 5 |
| Zhuhai Kerui Biotechnology Co., Ltd. | KP | keruipeptides.com | Zhuhai | 5 / 5 | 5 / 5 |
| GL Biochem (Shanghai) Ltd. | GL Biochem | glbiochem.net | Shanghai | 3 / 5 | 3 / 5 |
| Shanghai ERP Biotechnology Co., Ltd. | ERP | erpbiotechnology.com | Shanghai | 5 / 5 | 5 / 5 |
| Qingdao Saber Technology Pharmaceutical | QST | qingdaosabertechnology.com | Qingdao | 3 / 5 | 3 / 5 |
| Guangzhou JEEP Biotechnology Co., Ltd. | JEEP | jeepbio.com | Guangzhou | 4 / 5 | 4 / 5 |
| Scores are the Institute’s own, awarded against the published rubric on the documentation the Institute examined. They are not a statement about product quality; the Institute has tested nothing. | |||||
§8.2What a certificate for this compound must carry
- Identity by two orthogonal methods. Deconvolution should return an average mass within 2 daltons of 1815.09.
- Purity by a stated, stability-indicating method. The gradient, column and detection wavelength must be named, and the integration window reported.
- Peptide content. Determined against a named reference standard. Without it the certificate reports an area percentage rather than a content.
- Water content by Karl Fischer titration. AOD-9604 is supplied as a lyophilisate and residual water is a direct subtraction from delivered peptide mass.
- Counter-ion identity and content. Classified as a recommended rather than a critical field for this sequence, on the interpretive argument set out in the certificate-of-analysis standard.
- Batch traceability. A certificate that cannot be linked to the material in hand by batch identifier and date is a specimen document.
The full standard is CEI-MS-14. A working checker is at the certificate minimum-data checker.[1,2]
§9Evidence gaps
The Institute records evidence gaps as a numbered list on every monograph, because a gap that is not written down is not distinguishable from a question nobody asked. Each entry below is a study that has not been done, not a study that has been done badly.
- No human molecular target established
- The negative phase 2b result has not been followed by any adequately powered positive trial
- Oral bioavailability of the intact peptide has never been demonstrated
- Disulfide integrity is unreported across supply
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.
- International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. ICH Q6B Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products. ICH Harmonised Tripartite Guideline 1999;Step 4 version. identifier not held by the Institute
- 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.