vialroom

#coa-reading 2024-10-06

Sunday30 messages6 participantstimes are UTC
Highlights from this day
  • lot_number_lou — right so i asked Homopeptide for the method and they sent it. that alone put them ahead of most 18:19
  • bea_reconstitutes — slightly off topic but water content is why an honest 10mg vial assays at 9.1. karl fischer titration, and most certificates omit it 19:37
  • HPLC_Hank — update on the earlier thing i was wrong about this for a year: area percent under-reports nothing, it just answers a different question than assay does 19:52
  • bea_reconstitutes — retention time shifts between runs are normal. relative retention time is the number to compare, i have it written down somewhere 20:09
  • reship_rita — no lot number on this certificate, does that make it worthless an identical chromatogram on two different lots is the single biggest tell there is 20:55
LN

right so i asked Homopeptide for the method and they sent it. that alone put them ahead of most

DE

the related substances table is the interesting part. a row of "not detected" means they did not look hard

LN

if you only read one line on a certificate, read the lot number. if you read two, read the assay

why do some certificates report to one decimal and some to two

DE

tfa counterion runs higher by mass than acetate. if the certificate does not say, you cannot do the mass balance

HH

my 5mg vial weighed more than 10mg of powder, is the certificate lying

BR

slightly off topic but water content is why an honest 10mg vial assays at 9.1. karl fischer titration, and most certificates omit it

check the lot

update on the earlier thing i was wrong about this for a year: area percent under-reports nothing, it just answers a different question than assay does

BR

i keep every certificate in a dated folder and compare them. two suppliers had not changed their template since 2019

BR

retention time shifts between runs are normal. relative retention time is the number to compare, i have it written down somewhere

BR

no lot number, no certificate. a document you cannot tie to the vial in your hand is decoration

why would a vial be 96.8 pure and still assay under label

RR

no lot number on this certificate, does that make it worthless
an identical chromatogram on two different lots is the single biggest tell there is

no lot no certificate

RR

the honest summary is that a certificate tells you what the supplier says about a lot they chose to test

LN

two certificates from the same supplier have an identical chromatogram, is that normal

SB

sterility and endotoxin are separate tests and almost nobody runs either on research material

LN

a lab that reports "greater than 98%" rather than a number is telling you they did not integrate carefully

net peptide is gross mass minus water minus counterion. that is why 11.4mg of powder can be a correct 10mg vial

follow up mixed fonts and inconsistent kerning in one document is worth a second look, your mileage will differ