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THE JOURNAL / RESEARCH NOTES

The journal

Notes on molecules, analytical testing and research documentation.

6 articles

Updated

TB-500 and BPC-157: names, mass and molecular identity

A short product name does not define chemical identity. Reading a sample record means connecting the molecular name, structural form, reference mass and batch-specific analytical result.

Identity
Updated

Endotoxin testing: reading beyond “Pass”

“Pass” is a conclusion against a defined method and criterion. Units, sample dilution, assay sensitivity and interference controls provide the context needed to interpret the result.

Testing & COA
Updated

Lyophilized peptides: beyond the temperature log

A temperature log records exposure; stability evidence helps interpret its effect. Time, moisture, packaging and relevant tests matter alongside temperature. Lyophilization alone does not establish a shelf life.

Storage & stability
Updated

FDA nonclinical terminology: what the update changes

FDA’s September 2026 announcement recognizes appropriate non-animal approaches within nonclinical testing. The agency explicitly says evidentiary standards are unchanged; existing data are not automatically invalidated by terminology alone.

Regulatory notes
Updated

Semaglutide and tirzepatide: what a method must demonstrate

Using RP-HPLC does not make two analytical procedures equivalent. Suitability needs evidence for the intended measurement. Different molecules also do not, by themselves, prove that one method can never serve both.

Testing & COA
Updated

FDA temporary compounding policies: read the scope first

A temporary policy’s title is not its scope. The neonatal starter parenteral nutrition guidance identifies specific products and facilities, with appendices and time limits. Those conditions do not automatically extend to another product category.

Regulatory notes
Start with original sources

Each article links to its sources. Dates show when these notes were prepared; consult current original documents for regulatory scope and status.

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