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c/coa·submitted 11 months ago by u/wanjiru_varga

[Question] batch — what am I missing here

Questionbranch of 12 comments

batch — what am I missing here. If this has been answered properly somewhere, link me and I will delete. Ask what the stability statement was written against — temperature, light, and whether it was the lyophilised powder or the reconstituted solution. Those are three different claims. Related substances itemised…

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12 comments, started 11 months ago
u/tuva_aalto299 points·11 months ago

The PDF creation date being later than the analysis date is usually a re-issue or a re-export. It is worth one question and it is not evidence of anything on its own.

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u/karma_irrelevant-31 points·11 months ago

Why the same vial can honestly produce three different numbers.

Purity by area percent is relative to what the detector saw on one gradient at one wavelength. Net peptide content subtracts counterion, water and residual solvent. Mass of peptide per vial is net content times fill weight, and fill weight has its own tolerance.

So a document reading 99% purity, 6% acetate and 4% water is describing a vial that is about 90% peptide by mass, and every one of those numbers is honest. The mistake is treating the headline figure as the answer to "how much peptide did I get".

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u/amira_dumitru1 point·11 months ago

Agreed — the itemised related substances table is the difference between a document and a receipt.

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u/wanjiru_vargaOP1 point·11 months ago

Correcting myself upthread: I said the date was missing and it is on the second page, which I had not scrolled to.

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u/wanjiru_vargaOP1 point·11 months ago

Correction: that is net peptide content, not purity. Different number, different meaning, and the document says so if you read the row label.

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u/wanjiru_vargaOP191 points·11 months ago·edited

That is the catalogue certificate rather than the batch-specific one. Same layout, completely different status.

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u/yusuf_nakamura120 points·11 months ago

Is water content on the document? It changes your concentration arithmetic.

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u/rohan_steiner160 points·11 months ago

the lot on the vial has to match the lot on the page

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u/katrin_girard235 points·11 months ago

the counterion is part of the mass you paid for

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u/step_therapy_s183 points·11 months ago

HPLC-UV and LC-MS answer different questions

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u/priya_palacios431 points·11 months ago

the related substances line is where the story is

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u/laila_yilmaz100 points·11 months ago

Agreed on asking for the storage condition. It is one line and it changes how you read the entire stability claim.

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About c/coa

How to read a certificate of analysis and what it does and does not tell you. Area% versus mass%, identity versus quantity, water content, related substances, acetate counterions, and the difference between a vendor-supplied COA and an independent test on the vial you actually received.

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