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coa

Page 15 of 32 · 749 questions tagged coa.

749 questions · sorted by votes · page 15 of 32

20 votes5 answers16k views
Has anyone independently verified a BCH cagrilintide batch COA?

Stated plainly: BCH · cagrilintide. This is asserted often enough that I assumed it was established, and then I went looking for the source. I have searched the…

vendor-vetting
vendor-vetting

Evaluating a supplier on evidence rather than reputation: testing history across batches, whether certificates are batch-specific, how failures…

436 questions
coa
coa

Certificates of analysis: what fields a useful one carries, how to tell a real analytical report from a marketing document, batch and lot…

749 questions
batch-testing
batch-testing

Testing at the batch or lot level: sampling plans, how many vials from a lot need testing to say anything about the lot, and the difference…

865 questions
asked by colm_dunphy 16k · 2.3 years ago
20 votes 3 answers14k views
What should a certificate of analysis contain to be worth reading?

The lot number on the vial matches the certificate, which at least rules out the easy problem. I have done this once and I suspect I got away with it rather than got…

coa
coa

Certificates of analysis: what fields a useful one carries, how to tell a real analytical report from a marketing document, batch and lot…

749 questions
batch-testing
batch-testing

Testing at the batch or lot level: sampling plans, how many vials from a lot need testing to say anything about the lot, and the difference…

865 questions
vendor-vetting
vendor-vetting

Evaluating a supplier on evidence rather than reputation: testing history across batches, whether certificates are batch-specific, how failures…

436 questions
residual-solvent
residual-solvent

Solvents left behind by synthesis and purification - acetonitrile, TFA, DMF, DCM - their ICH limits, how they are measured by headspace GC, and…

14 questions
asked by linnea_wahlberg 14k · 23 months ago
20 votes5 answers12k views
How does WXT compare to Shanghai Sigma-Audley on documentation quality?

Stated plainly: WXT · Shanghai Sigma-Audley. I suspect the honest answer is that it depends, in which case I would like to know on what. Assume I can obtain either…

vendor-comparison
vendor-comparison

Side-by-side comparison of suppliers on measurable axes - independently confirmed purity and content, lead time, cold-chain handling,…

351 questions
coa
coa

Certificates of analysis: what fields a useful one carries, how to tell a real analytical report from a marketing document, batch and lot…

749 questions
vendor-vetting
vendor-vetting

Evaluating a supplier on evidence rather than reputation: testing history across batches, whether certificates are batch-specific, how failures…

436 questions
asked by triple_agonist_q 37k · 21 months ago
20 votes 5 answers9.9k views
How do I reconcile 95.2% from Janoshik with 99.4% from the supplier?

What I have: 95.2% · Janoshik · 99.4%. I have a result I cannot explain, and I would rather diagnose it than guess. I have checked the obvious explanations and…

purity
purity

Purity as chromatographic area per cent - the fraction of detected material that is your target peak. It says nothing about how much material is…

788 questions
batch-testing
batch-testing

Testing at the batch or lot level: sampling plans, how many vials from a lot need testing to say anything about the lot, and the difference…

865 questions
coa
coa

Certificates of analysis: what fields a useful one carries, how to tell a real analytical report from a marketing document, batch and lot…

749 questions
asked by cake_intact 18k · 16 months ago
20 votes 3 answers9.5k views
Would you re-test semaglutide after four weeks at 4 °C, or accept the original certificate?

The case in front of me: semaglutide · four weeks · 4 °C. The failure mode I am trying to avoid is making this decision emotionally. I have twelve months in view and…

batch-testing
batch-testing

Testing at the batch or lot level: sampling plans, how many vials from a lot need testing to say anything about the lot, and the difference…

865 questions
peptide-stability
peptide-stability

The chemistry of peptide degradation: deamidation, oxidation, hydrolysis, aggregation and fibrillation, and how temperature, pH, ionic strength,…

832 questions
coa
coa

Certificates of analysis: what fields a useful one carries, how to tell a real analytical report from a marketing document, batch and lot…

749 questions
asked by haze_check 17k · 20 months ago
20 votes 5 answers9.3k views
What would change my mind about a vendor I currently trust?

The lane and the lead time matter as much as the material for what I am doing. I would like to define my thresholds before I have a result, for obvious reasons. I…

vendor-vetting
vendor-vetting

Evaluating a supplier on evidence rather than reputation: testing history across batches, whether certificates are batch-specific, how failures…

436 questions
batch-testing
batch-testing

Testing at the batch or lot level: sampling plans, how many vials from a lot need testing to say anything about the lot, and the difference…

865 questions
coa
coa

Certificates of analysis: what fields a useful one carries, how to tell a real analytical report from a marketing document, batch and lot…

749 questions
asked by pk_curve 12k · 8 months ago
20 votes 5 answers8.4k views
What should I make of an orforglipron certificate that has no sampling plan?

Setup, so nobody has to ask: orforglipron · sampling plan. I have read the primary source rather than the summary, which has left me with more questions. I understand…

coa
coa

Certificates of analysis: what fields a useful one carries, how to tell a real analytical report from a marketing document, batch and lot…

749 questions
vendor-vetting
vendor-vetting

Evaluating a supplier on evidence rather than reputation: testing history across batches, whether certificates are batch-specific, how failures…

436 questions
batch-testing
batch-testing

Testing at the batch or lot level: sampling plans, how many vials from a lot need testing to say anything about the lot, and the difference…

865 questions
asked by threadlock7 14k · 4 months ago
20 votes 5 answers8.1k views
How do I reconcile 97.1% from Janoshik with 98.4% from the supplier?

What I have: 97.1% · Janoshik · 98.4%. Before I write this off, I want to check whether it is a known failure mode. I have the lot number, the certificate and the…

purity
purity

Purity as chromatographic area per cent - the fraction of detected material that is your target peak. It says nothing about how much material is…

788 questions
batch-testing
batch-testing

Testing at the batch or lot level: sampling plans, how many vials from a lot need testing to say anything about the lot, and the difference…

865 questions
coa
coa

Certificates of analysis: what fields a useful one carries, how to tell a real analytical report from a marketing document, batch and lot…

749 questions
asked by second_lot 11k · 4 months ago
20 votes 5 answers7.2k views
Would you re-test a GLP-1 receptor agonist after sixteen weeks at minus 20 °C, or accept the original certificate?

What I have: a GLP-1 receptor agonist · sixteen weeks · minus 20 °C. I would rather over-plan the first cycle and simplify later. I am prepared to do the work if…

batch-testing
batch-testing

Testing at the batch or lot level: sampling plans, how many vials from a lot need testing to say anything about the lot, and the difference…

865 questions
peptide-stability
peptide-stability

The chemistry of peptide degradation: deamidation, oxidation, hydrolysis, aggregation and fibrillation, and how temperature, pH, ionic strength,…

832 questions
coa
coa

Certificates of analysis: what fields a useful one carries, how to tell a real analytical report from a marketing document, batch and lot…

749 questions
asked by t_oyelaran 41k · 2 months ago
20 votes3 answers7.1k views
What does a method section on a TFC report change about how I read it?

For reference: method section · TFC. I have the document in front of me and I can read the numbers. What I cannot do is interpret them. I am reasonably comfortable…

coa
coa

Certificates of analysis: what fields a useful one carries, how to tell a real analytical report from a marketing document, batch and lot…

749 questions
batch-testing
batch-testing

Testing at the batch or lot level: sampling plans, how many vials from a lot need testing to say anything about the lot, and the difference…

865 questions
vendor-vetting
vendor-vetting

Evaluating a supplier on evidence rather than reputation: testing history across batches, whether certificates are batch-specific, how failures…

436 questions
asked by lipid_panel_q 44k · 8 months ago
20 votes 5 answers5.9k views
What does a 97.1% purity with a list of related substances attached let me conclude?

The particulars: 97.1% · list of related substances. I have the document in front of me and I can read the numbers. What I cannot do is interpret them. I am…

purity
purity

Purity as chromatographic area per cent - the fraction of detected material that is your target peak. It says nothing about how much material is…

788 questions
coa
coa

Certificates of analysis: what fields a useful one carries, how to tell a real analytical report from a marketing document, batch and lot…

749 questions
hplc
hplc

Reverse-phase high-performance liquid chromatography, the workhorse purity method. Column chemistry, mobile-phase choice, gradient slope,…

466 questions
asked by klara_novotna 16k · 4 months ago
20 votes3 answers5.9k views
How many vials from a QYB lot should I send for an endotoxin test?

The particulars: QYB · an endotoxin test. I would like the arithmetic checked rather than the conclusion asserted. I have deliberately not used an online calculator…

batch-testing
batch-testing

Testing at the batch or lot level: sampling plans, how many vials from a lot need testing to say anything about the lot, and the difference…

865 questions
coa
coa

Certificates of analysis: what fields a useful one carries, how to tell a real analytical report from a marketing document, batch and lot…

749 questions
cost-analysis
cost-analysis

Cost arithmetic done honestly: cost per milligram after dead-space loss, list versus net price, comparing a multi-dose vial to a fixed-dose pen,…

261 questions
asked by lyoph_cake 95k · 2 months ago
20 votes 5 answers4.8k views
What does a quantified content assay add for tirzepatide that a purity figure does not?

The case in front of me: a quantified content assay · tirzepatide. I would like the axes of comparison first and the recommendation second. I have tried the first…

content-assay
content-assay

Quantified content: how many milligrams of peptide are actually in the vial, measured against a calibrated reference standard. A separate test…

438 questions
purity
purity

Purity as chromatographic area per cent - the fraction of detected material that is your target peak. It says nothing about how much material is…

788 questions
coa
coa

Certificates of analysis: what fields a useful one carries, how to tell a real analytical report from a marketing document, batch and lot…

749 questions
asked by grainne_ahearn 13k · 3 months ago
20 votes 5 answers4.6k views
Is a residual-solvent screen on one vial from a ten-person group buy enough for the whole split?

What I am working with: a residual-solvent screen · a ten-person group buy. I would like to set this up properly once, rather than adjust it repeatedly. My budget is…

group-buy
group-buy

Pooled purchasing: how the economics work, what trust structure a pool needs, splitting a single tested lot, and the failure modes when the…

41 questions
batch-testing
batch-testing

Testing at the batch or lot level: sampling plans, how many vials from a lot need testing to say anything about the lot, and the difference…

865 questions
coa
coa

Certificates of analysis: what fields a useful one carries, how to tell a real analytical report from a marketing document, batch and lot…

749 questions
asked by gel_pack_warm 13k · 5 months ago
20 votes 1 answer4.6k views
How many vials from a WWB lot should I send for a Karl Fischer water content test?

Details up front: WWB · a Karl Fischer water content test. I can do the algebra. I am not confident about the conversion factors. If there is a standard way to lay…

batch-testing
batch-testing

Testing at the batch or lot level: sampling plans, how many vials from a lot need testing to say anything about the lot, and the difference…

865 questions
coa
coa

Certificates of analysis: what fields a useful one carries, how to tell a real analytical report from a marketing document, batch and lot…

749 questions
cost-analysis
cost-analysis

Cost arithmetic done honestly: cost per milligram after dead-space loss, list versus net price, comparing a multi-dose vial to a fixed-dose pen,…

261 questions
asked by noor_alhassan 15k · 6 months ago
20 votes 4 answers3.9k views
What does PeptideMeter verification of Qingdao Saber Technology actually cover?

The particulars: PeptideMeter · Qingdao Saber Technology. I want to understand what this actually establishes, as opposed to what it is being used to imply. My…

vendor-investigate
vendor-investigate

VendorInvestigate, an independent vendor review and verification service. Use this tag for questions about its verification criteria, what a…

41 questions
vendor-vetting
vendor-vetting

Evaluating a supplier on evidence rather than reputation: testing history across batches, whether certificates are batch-specific, how failures…

436 questions
coa
coa

Certificates of analysis: what fields a useful one carries, how to tell a real analytical report from a marketing document, batch and lot…

749 questions
asked by rune_thoresen 14k · 1 months ago
19 votes5 answers36k views
Why does compounded mazdutide potency vary between pharmacies?

I have been through one internal appeal already and would like to do the next one properly. I suspect the usual explanation for this is wrong, or at least incomplete.…

compounding
compounding

Compounded preparations: what a 503A and a 503B facility may legally prepare and when, base versus salt forms, beyond-use dating under USP…

61 questions
content-assay
content-assay

Quantified content: how many milligrams of peptide are actually in the vial, measured against a calibrated reference standard. A separate test…

438 questions
coa
coa

Certificates of analysis: what fields a useful one carries, how to tell a real analytical report from a marketing document, batch and lot…

749 questions
asked by tyndall_haze 48k · 2.2 years ago
19 votes 2 answers32k views
How many vials from an MKM lot should I send for a residual-solvent screen?

The particulars: MKM · a residual-solvent screen. I would rather understand the derivation than memorise the outcome. Two people I asked gave two answers that differ…

batch-testing
batch-testing

Testing at the batch or lot level: sampling plans, how many vials from a lot need testing to say anything about the lot, and the difference…

865 questions
coa
coa

Certificates of analysis: what fields a useful one carries, how to tell a real analytical report from a marketing document, batch and lot…

749 questions
cost-analysis
cost-analysis

Cost arithmetic done honestly: cost per milligram after dead-space loss, list versus net price, comparing a multi-dose vial to a fixed-dose pen,…

261 questions
asked by eoin_mcgarry 16k · 2.0 years ago
19 votes 5 answers31k views
Why is endotoxin testing separate from a sterility test?

I have a logging thermometer, a box of insulin syringes and no illusions about my worktop being sterile. I can predict the outcome but I cannot explain it, which…

endotoxin
endotoxin

Bacterial endotoxin: LAL and kinetic chromogenic methods, how an endotoxin limit is derived from a dose, why endotoxin survives autoclaving, and…

14 questions
sterility
sterility

Sterility as a test result rather than an adjective. Covers what a sterility test actually measures, why "sterile filtered" on a document is close…

122 questions
coa
coa

Certificates of analysis: what fields a useful one carries, how to tell a real analytical report from a marketing document, batch and lot…

749 questions
asked by swab_and_wait 15k · 2.2 years ago
19 votes5 answers27k views
What does a date of analysis on a TFC report change about how I read it?

The specifics, since they change the answer: date of analysis · TFC. I want to understand what this actually establishes, as opposed to what it is being used to…

coa
coa

Certificates of analysis: what fields a useful one carries, how to tell a real analytical report from a marketing document, batch and lot…

749 questions
batch-testing
batch-testing

Testing at the batch or lot level: sampling plans, how many vials from a lot need testing to say anything about the lot, and the difference…

865 questions
vendor-vetting
vendor-vetting

Evaluating a supplier on evidence rather than reputation: testing history across batches, whether certificates are batch-specific, how failures…

436 questions
asked by orla_sheridan 14k · 21 months ago
19 votes 5 answers21k views
What does "identity confirmed" mean without a quantified content figure?

I am comparing a supplier certificate against an independent result on the same lot. I would like help reading this properly rather than being told what conclusion to…

coa
coa

Certificates of analysis: what fields a useful one carries, how to tell a real analytical report from a marketing document, batch and lot…

749 questions
content-assay
content-assay

Quantified content: how many milligrams of peptide are actually in the vial, measured against a calibrated reference standard. A separate test…

438 questions
mass-spec
mass-spec

Mass spectrometry for identity confirmation: electrospray ionisation, multiple charge states, monoisotopic versus average mass, deconvolution, and…

38 questions
asked by dermot_kiely 14k · 14 months ago
19 votes 5 answers19k views
How do I reconcile 96.8% from Medutest with 97.6% from the supplier?

Stated plainly: 96.8% · Medutest · 97.6%. I noticed this today and I have not touched anything since, in case the state is diagnostic. I have not discarded anything…

purity
purity

Purity as chromatographic area per cent - the fraction of detected material that is your target peak. It says nothing about how much material is…

788 questions
batch-testing
batch-testing

Testing at the batch or lot level: sampling plans, how many vials from a lot need testing to say anything about the lot, and the difference…

865 questions
coa
coa

Certificates of analysis: what fields a useful one carries, how to tell a real analytical report from a marketing document, batch and lot…

749 questions
asked by jo_vandeberg 19k · 14 months ago
19 votes 3 answers17k views
What does a 97.9% purity with a purity figure attached let me conclude?

What I have: 97.9% · purity figure. I can parse the result. I am less sure what it licenses me to conclude. I have deliberately not looked at anyone else’s…

purity
purity

Purity as chromatographic area per cent - the fraction of detected material that is your target peak. It says nothing about how much material is…

788 questions
coa
coa

Certificates of analysis: what fields a useful one carries, how to tell a real analytical report from a marketing document, batch and lot…

749 questions
hplc
hplc

Reverse-phase high-performance liquid chromatography, the workhorse purity method. Column chemistry, mobile-phase choice, gradient slope,…

466 questions
asked by ten_mg_vial 16k · 9 months ago
19 votes 4 answers17k views
What should I make of a tirzepatide certificate that has no list of related substances?

The particulars: tirzepatide · list of related substances. I want to understand what this actually establishes, as opposed to what it is being used to imply. My…

coa
coa

Certificates of analysis: what fields a useful one carries, how to tell a real analytical report from a marketing document, batch and lot…

749 questions
vendor-vetting
vendor-vetting

Evaluating a supplier on evidence rather than reputation: testing history across batches, whether certificates are batch-specific, how failures…

436 questions
batch-testing
batch-testing

Testing at the batch or lot level: sampling plans, how many vials from a lot need testing to say anything about the lot, and the difference…

865 questions
asked by k_szabo 45k · 9 months ago