Mazdutide — analytical characterisation
Chromatographic conditions, identity, related substances, presentation, reconstitution and in-use stability.
§6Analytical characterisation
§6.1Chromatographic conditions
- Column
- C18, 2.1 × 150 mm, 1.7 µm
- Mobile phase and gradient
- A: 0.1 % formic acid in water; B: acetonitrile with 0.1 % formic acid. Gradient 25–58 % B over 30 min
- Detection
- UV 214 nm
- Retention
- Intermediate among the acylated dual agonists
§6.2Identity by mass spectrometry
Deconvoluted average mass near 4600 Da. The Institute regards published mass and CAS records for this compound as unreliable and requires comparison against a primary reference standard.[3]
§6.3Related substances and degradation
Table 7. Related substances recorded for Mazdutide, with the process or storage route that generates each and its analytical signature.
| Related substance | Origin | Analytical signature |
|---|---|---|
| Sequence-variant material | Supplier ambiguity | Dominant identity risk |
| Non-acylated backbone | Failed conjugation | Large negative shift |
| Deamidated forms | Storage | +1 Da |
Degradation routes
- Not characterised publicly
- Class-typical routes assumed
§7Presentation, reconstitution and storage
§7.1Presentation and reconstitution
- Presentation
- Solution for injection (approved product in China); lyophilised powder in research supply
- Reconstitution
- A 5 mg vial with 1.0 mL gives 5 mg/mL; a 4 mg dose is 0.80 mL, that is 80 units on a U-100 syringe.
- Storage, lyophilised
- 2–8 °C
- Storage, reconstituted
- 2–8 °C
- In-use period
- Refer to the approving jurisdiction’s labelling; no Institute in-use claim for research material
This is the first monograph in the series describing a compound whose only marketing authorisation is in China, and the Institute treats the regulatory status and the evidence status as separate questions.
§7.2In-use stability
Applicable standards: CEI-MS-01 · CEI-MS-02 · CEI-MS-03 · CEI-MS-04 · CEI-MS-05 · CEI-MS-06. The full series is at methodological standards.
Working calculators: reconstitution and insulin-unit conversion · purity against peptide content · certificate minimum-data checker.
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.
- 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
- International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. ICH Q2(R2) Validation of Analytical Procedures. ICH Harmonised Guideline 2023;Step 4 version, 1 November 2023. identifier not held by the Institute
- 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
- International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. ICH Q1A(R2) Stability Testing of New Drug Substances and Products. ICH Harmonised Tripartite Guideline 2003;Step 4 version. identifier not held by the Institute
- Manning MC, Chou DK, Murphy BM, Payne RW, Katayama DS. Stability of protein pharmaceuticals: an update. Pharmaceutical Research 2010;27(4):544–575. doi:10.1007/s11095-009-0045-6 · PMID 20143256
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.