Thymalin Certificate of Analysis
Source batch LZ-THY-260826 · certificate LZ-COA-THY-260830 · analysed August 27, 2026
This Certificate of Analysis covers batch LZ-THY-260826 of Thymalin, manufactured on August 26, 2026 and analysed on August 27, 2026. Purity is 99.33%, determined against the specification stated in the results table. The batch was released on August 30, 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-THY-260826 of Thymalin. All Thymalin vial strengths offered under this batch (10 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-THY-260826 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-THY-260826
- 10mg
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-THY-260826 | LZ-COA-THY-260830 | 99.33% | Currently shipping |
| LZ-THY-260806 | LZ-COA-THY-260810 | 99.33% | Superseded August 26, 2026 |
Open the standalone certificate document·View Thymalin product page·All batch results
| Test Parameter | Analytical Method | Specification | Result | Status |
|---|---|---|---|---|
| Total Peptide Content | Lowry Assay (BSA standard) | ≥98.0% | 99.33% | PASS |
| Appearance | Visual Inspection | White to off-white lyophilized powder | Conforms | PASS |
| MW Distribution | SDS-PAGE (Tricine, silver stain) | Bands 1–10 kDa, no high-MW contaminants | Conforms | PASS |
| RP-HPLC Profile | RP-HPLC (C18, 220 nm) | Conforms to reference fingerprint | Conforms | PASS |
| Water Content | Karl Fischer Titration (KF) | ≤8.0% | 4.70% | PASS |
| Sterility | USP <71> Membrane Filtration | No growth (14 days) | No growth | PASS |
| Bacterial Endotoxins | Limulus Amebocyte Lysate (LAL) | <1.0 EU/mg | <0.1 EU/mg | PASS |
| Residual Solvents | Headspace GC-FID (USP <467>) | Acetonitrile ≤ 410 ppm; dichloromethane ≤ 600 ppm; methanol ≤ 3000 ppm (ICH Q3C) | Conforms | 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 |
| pH (1% aq. solution) | Potentiometry (25°C) | 4.0 – 7.5 | 5.4 | PASS |
| System suitability | Requirement | Result |
|---|---|---|
| Tailing factor, main peak | ≤ 2.0 | 1.20 |
| Theoretical plates, main peak | ≥ 2,000 | 12,910 |
| Resolution, closest eluting pair | ≥ 2.0 | 5.1 |
| Injection repeatability, %RSD (n = 6) | ≤ 2.0% | 0.44% |
| Reference standard recovery | 98.0 to 102.0% | 100.4% |
| Test | Method | Requirement | Result |
|---|---|---|---|
| Peptide mapping | Tryptic digest followed by LC-MS/MS, sequence coverage by database match | ≥ 90% sequence coverage; no unassigned peaks above 1% of base peak | 92.8% coverage; all major peaks assigned |
| Lot | Certificate | Manufactured | Analysed | Purity | Water | Endotoxin | Disposition |
|---|---|---|---|---|---|---|---|
| LZ-THY-260826 (this lot) | LZ-COA-THY-260830 | August 26, 2026 | August 27, 2026 | 99.33% | 4.70% | <0.1 EU/mg | Released |
| LZ-THY-260806 | LZ-COA-THY-260810 | August 6, 2026 | August 7, 2026 | 99.33% | 4.70% | <0.1 EU/mg | Released, superseded August 26, 2026 |
| LZ-THY-260526 | LZ-COA-THY-260530 | May 26, 2026 | May 27, 2026 | 99.30% | 3.34% | <0.1 EU/mg | Released |
| Solvent | Class | Limit | Result | LOQ |
|---|---|---|---|---|
| Acetonitrile | Class 2 | 410 ppm | < 10 ppm | 10 ppm |
| Methanol | Class 2 | 3,000 ppm | < 50 ppm | 50 ppm |
| Ethanol | Class 3 | 5,000 ppm | 315 ppm | 50 ppm |
| 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 | 0.46 ppm | 0.10 ppm |
| Mercury (Hg) | Class 1 | 0.30 ppm | 0.11 ppm | 0.05 ppm |
| Cobalt (Co) | Class 2A | 0.50 ppm | 0.15 ppm | 0.05 ppm |
| Nickel (Ni) | Class 2A | 2.00 ppm | < 0.10 ppm | 0.10 ppm |
| Vanadium (V) | Class 2A | 1.00 ppm | 0.12 ppm | 0.10 ppm |
| Test | Method | Limit | Result |
|---|---|---|---|
| Total aerobic microbial count (TAMC) | USP <61>, membrane filtration | ≤ 100 CFU/g | < 10 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.