Trevogrumab (Anti-Myostatin / GDF-8 mAb) Certificate of Analysis
Source batch LZ-TRV-260825 · certificate LZ-COA-TRV-260829 · analysed August 27, 2026
This Certificate of Analysis covers batch LZ-TRV-260825 of Trevogrumab (Anti-Myostatin / GDF-8 mAb), manufactured on August 25, 2026 and analysed on August 27, 2026. This is a co-formulation of 2 components: Monomer, Non-Reduced. Each is assayed against its own reference standard, and the headline figure of 99.1% is the LOWEST single-component purity, not a figure for the mixture. Identity was confirmed by mass spectrometry at 144,041 Da, within the expected 144,038 ± 100 Da. The batch was released on August 29, 2026 and independently confirmed by Janoshik Analytical, working to ISO/IEC 17025:2017. Every figure below is specific to this batch.
Batch and certificate applicability
This Certificate of Analysis applies specifically to source batch LZ-TRV-260825 of Trevogrumab (Anti-Myostatin / GDF-8 mAb). All Trevogrumab (Anti-Myostatin / GDF-8 mAb) vial strengths offered under this batch (0.1 mg, 1 mg, 5 mg, 10 mg and 100 mg) were filled from the same source batch identified above. The certificate therefore reports the analytical results for that source batch and is not a generic or product-wide certificate. Each finished vial carries a lot identifier traceable to source batch LZ-TRV-260825 through our filling and packaging records. If a subsequent source batch is introduced it receives a separate batch identifier and separate analytical documentation.
Strengths filled from batch LZ-TRV-260825
- 0.1mg
- 1mg
- 5mg
- 10mg
- 100mg
How one batch becomes every strength
- 1Source batch — one synthesis lot
- 2QC tested — analysed as a batch, before any filling
- 3Released — passed specification
- 4Filled — into every strength offered under the batch
- 5Finished vials — each lot traceable to the source batch
Batch history
| Source batch | Certificate | Purity | Status |
|---|---|---|---|
| LZ-TRV-260825 | LZ-COA-TRV-260829 | 99.1% | Currently shipping |
| LZ-TRV-260805 | LZ-COA-TRV-260809 | 99.1% | Superseded August 25, 2026 |
Open the standalone certificate document·View Trevogrumab (Anti-Myostatin / GDF-8 mAb) product page·All batch results
| Test Parameter | Analytical Method | Specification | Result | Status |
|---|---|---|---|---|
| Appearance (Lyophilized) | Visual Inspection | White to off-white lyophilized cake | Conforms | PASS |
| Appearance (Reconstituted) | Visual Inspection | Clear to slightly opalescent, colourless to pale yellow, essentially free of visible particulates | Conforms | PASS |
| Purity (Monomer) | SEC-HPLC (300Å, 280 nm) | ≥98.0% | 99.1% | PASS |
| Aggregate Content (HMW) | SEC-HPLC (high molecular weight species) | ≤2.0% | 0.7% | PASS |
| Purity (Non-Reduced) | SDS-PAGE, non-reduced, densitometry | ≥95.0% intact IgG at ~150 kDa | 97.8% | PASS |
| Identity (Chain Integrity) | SDS-PAGE, reduced, Coomassie | Two bands at ~50 kDa (heavy) and ~25 kDa (light) | Conforms | PASS |
| Identity (Intact Mass) | LC-ESI-QTOF MS, PNGase F deglycosylated | 144,038 ± 100 Da | 144,041 Da | PASS |
| Binding Activity | ELISA, immobilised human GDF-8 | EC₅₀ ≤ 5.0 nM | 1.4 nM | PASS |
| Selectivity (GDF11) | ELISA counter-screen, human GDF11 | No measurable binding at 100 nM | No binding detected | PASS |
| Protein Concentration | UV absorbance A₂₈₀ (ε = 1.42 mL·mg⁻¹·cm⁻¹) | Report result | 10.2 mg/mL (reconstituted) | PASS |
| pH | Potentiometry (25°C) | 5.5 – 6.5 | 6.0 | PASS |
| Bacterial Endotoxins | Kinetic chromogenic LAL | <1.0 EU/mg | <0.05 EU/mg | PASS |
| Elemental Impurities | ICP-MS (USP <232>/<233>) | Pb ≤ 5, Cd ≤ 2, As ≤ 15, Hg ≤ 3 µg/day (ICH Q3D, parenteral) | Conforms | PASS |
| Microbial Limits | USP <61> / <62> | TAMC ≤ 100 CFU/g; TYMC ≤ 10 CFU/g; absence of specified organisms | Conforms | PASS |
| System suitability | Requirement | Result |
|---|---|---|
| Peak symmetry, monomer | 0.8 to 1.5 | 0.95 |
| Theoretical plates, main peak | ≥ 2,000 | 14,363 |
| Resolution, closest eluting pair | ≥ 2.0 | 4.2 |
| Injection repeatability, %RSD (n = 6) | ≤ 2.0% | 0.38% |
| Reference standard recovery | 98.0 to 102.0% | 100.1% |
| Peak | RT (min) | RRT | Area (µV·s) | Area % | Assignment |
|---|---|---|---|---|---|
| 1 | 7.12 | 0.82 | 6,424 | 0.31 | Related substance |
| 2 | 7.90 | 0.91 | 4,766 | 0.23 | Related substance |
| 3 | 8.60 | 1.00 | 2,053,622 | 99.10 | Monomer |
| 4 | 9.28 | 1.07 | 3,937 | 0.19 | Related substance |
| 5 | 10.31 | 1.19 | 3,523 | 0.17 | Related substance |
| Measurement | Theoretical | Observed | Deviation |
|---|---|---|---|
| Neutral mass | 144037.80 Da | 144041.00 Da | +3.000 Da (+20.8 ppm) |
| Base peak m/z | 144038.00 | 144041.00 | +20.8 ppm |
| Test | Method | Requirement | Result |
|---|---|---|---|
| Charge variant distribution | Imaged capillary isoelectric focusing (icIEF) | Main isoform ≥ 60%; profile comparable to the reference standard | Main 74.7%, acidic 15.9%, basic 10.2%; profile comparable |
| Lot | Certificate | Manufactured | Analysed | Purity | Water | Endotoxin | Disposition |
|---|---|---|---|---|---|---|---|
| LZ-TRV-260825 (this lot) | LZ-COA-TRV-260829 | August 25, 2026 | August 27, 2026 | 99.10% | Not applicable | <0.05 EU/mg | Released |
| LZ-TRV-260805 | LZ-COA-TRV-260809 | August 5, 2026 | August 7, 2026 | 99.1% | Not applicable | <0.05 EU/mg | Released, superseded August 25, 2026 |
| LZ-TRV-260502 | LZ-COA-TRV-260506 | May 2, 2026 | May 4, 2026 | 99.03% | Not applicable | <0.05 EU/mg | Released |
| Element | Class | Limit | Result | LOQ |
|---|---|---|---|---|
| Cadmium (Cd) | Class 1 | 0.20 ppm | 0.05 ppm | 0.05 ppm |
| Lead (Pb) | Class 1 | 0.50 ppm | < 0.05 ppm | 0.05 ppm |
| Arsenic (As) | Class 1 | 1.50 ppm | 0.12 ppm | 0.10 ppm |
| Mercury (Hg) | Class 1 | 0.30 ppm | < 0.05 ppm | 0.05 ppm |
| Cobalt (Co) | Class 2A | 0.50 ppm | < 0.05 ppm | 0.05 ppm |
| Nickel (Ni) | Class 2A | 2.00 ppm | < 0.10 ppm | 0.10 ppm |
| Vanadium (V) | Class 2A | 1.00 ppm | 0.23 ppm | 0.10 ppm |
| Test | Method | Limit | Result |
|---|---|---|---|
| Total aerobic microbial count (TAMC) | USP <61>, membrane filtration | ≤ 100 CFU/g | 26 CFU/g |
| Total combined yeasts and moulds (TYMC) | USP <61>, membrane filtration | ≤ 10 CFU/g | < 10 CFU/g |
| Escherichia coli | USP <62> | Absent in 1 g | Absent |
| Staphylococcus aureus | USP <62> | Absent in 1 g | Absent |
| Pseudomonas aeruginosa | USP <62> | Absent in 1 g | Absent |
| Salmonella species | USP <62> | Absent in 10 g | Absent |
| Bile-tolerant Gram-negative bacteria | USP <62> | ≤ 10 CFU/g | < 10 CFU/g |
| Sterility | USP <71>, membrane filtration, fluid thioglycollate and soybean-casein digest media, 14 days at 22.5 °C and 32.5 °C | No growth | No growth in either medium at 14 days |
I. Analytical Testing Declaration
All analytical data presented in this Certificate of Analysis was generated using validated in-house analytical procedures conducted under GMP quality control protocols within LyzeLabs Research Division facilities, and independently confirmed by third-party analysis. Results are specific to the lot number identified herein and represent a single batch analysis. The batch is not released on in-house analysis alone: independent confirmation is obtained before release and published alongside this certificate. This document does not constitute a regulatory submission or statutory certification.
II. Research Use Only
This compound is supplied exclusively as an analytical reference standard for in vitro laboratory and research purposes. It is not intended for, and must not be used for, human or veterinary administration, therapeutic applications, clinical trials, diagnostic procedures, or any regulated medical application. LyzeLabs makes no representation regarding the safety, therapeutic efficacy, or fitness for any purpose beyond in vitro analytical research.
III. Jurisdictional Compliance
The purchaser assumes full and sole legal responsibility for ensuring compliance with all applicable laws, statutes, regulations, and institutional requirements governing the acquisition, import, export, possession, storage, handling, and use of this research compound in their jurisdiction. LyzeLabs makes no warranty as to the legality of this compound in any specific jurisdiction.
IV. Document Integrity
This certificate is published in full and may be reproduced and cited freely, provided it is reproduced unaltered and in its entirety. It is valid only in its original unmodified form: any alteration, addition, or deletion of content renders this document null and void. The authoritative copy is the one published at lyzelabs.com/coa.
V. Limitation of Liability
Lyze Labs expressly disclaims all warranties, express or implied, with respect to the goods and data described herein, including but not limited to implied warranties of merchantability or fitness for a particular purpose. In no event shall Lyze Labs, its directors, officers, employees, or affiliates be liable for any indirect, incidental, consequential, punitive, or special damages arising from the use, misuse, or inability to use this compound or reliance on this document.