Test methods
Review each release test, its required standard and the information each lot's certificate will report.
- Testing
- Independent laboratory, Texas
- Certificate
- Not yet published
- Status
- Launching end of 2026. Lot documentation pending.
Sample components move through the column at different rates.Illustration of the methodUHPLC
Instrument: Agilent 1290 Infinity II
What the certificate will report
The measured purity, in percent.
View test standard
Ion motion is used to measure mass-to-charge ratios.Illustration of the methodOrbitrap
Instrument: Orbitrap high resolution mass spectrometer
What the certificate will report
The measured mass compared with the reference mass.
View test standard
Fragment ions are compared with an expected molecular pattern.Illustration of the methodLC-MS/MS
Instrument: Triple quadrupole LC-MS/MS system
What the certificate will report
The measured sequence compared with the reference sequence.
View test standard
Elements are ionised, then measured by mass-to-charge ratio.Illustration of the methodICP-MS
Instrument: ICP mass spectrometer
What the certificate will report
Each measured element compared with its specified limit.
View test standard
Example setup: filtration and growth media precede a controlled incubation period.Illustration of the methodUSP <71>
Standard: United States Pharmacopeia <71>
What the certificate will report
The sterility result.
View test standard
A chromogenic LAL assay illustrates a response to bacterial endotoxins.Illustration of the methodUSP <85>
Standard: United States Pharmacopeia <85>
What the certificate will report
The endotoxin result, in EU per mg.
View test standardCertificate of analysis
- Product
- Blank
- Strength
- Blank
- Lot
- LOT —
| Test | Method | Result |
|---|---|---|
| Purity | UHPLC | Blank |
| Identity | Orbitrap HRMS | Blank |
| Sequence | LC-MS/MS | Blank |
| Elemental impurities | ICP-MS | Blank |
| Sterility | USP <71> | Blank |
| Bacterial endotoxins | USP <85> | Blank |
| Condition | Specification | Result |
|---|---|---|
| Storage | -20 °C | Blank |
| Container | Amber USP Type I glass | Blank |
SPECIMEN, no lot released
Compare the test methods
Compare the testing standards and the information each lot's certificate will report.
| Test and method | Standard | What the certificate will report |
|---|---|---|
![]() | Purity by UHPLC on an Agilent 1290 Infinity II. A lot is released at 99 percent purity or above. No lot has been released, so no chromatogram is on file yet. | The measured purity, in percent. |
![]() | Identity by Orbitrap high resolution mass spectrometry, molecular weight against the reference, on every lot before release. No identity record is on file yet. | The measured mass compared with the reference mass. |
![]() | Sequence confirmation by LC-MS/MS against the reference, on every lot before release. No sequence record is on file yet. | The measured sequence compared with the reference sequence. |
![]() | Elemental impurity screening by ICP-MS, with each result reported against its limit. No results have been issued yet. | Each measured element compared with its specified limit. |
![]() | Sterility testing to USP <71> is required for every lot. Testing has not yet been performed. | The sterility result. |
![]() | Bacterial endotoxin by LAL assay to USP <85> on every lot. No assay has been run yet. | The endotoxin result, in EU per mg. |
| Independent testing, Texas | Every lot is tested by an independent laboratory in Texas before it is released. No lot has been released yet. | The independent laboratory in Texas named on the certificate. |
| Certificate of analysis | Each lot's certificate of analysis will be published on its documentation record before shipment, identifying the laboratory, instruments and test results. No certificate has been issued yet. | The certificate number and the lot number associated with its results. |





