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coa

Page 26 of 32 · 749 questions tagged coa.

749 questions · sorted by votes · page 26 of 32

9 votes 3 answers3.4k views
What does 97.6% purity on a C4 column actually tell me about a dulaglutide vial?

Concretely: 97.6% · a C4 column · dulaglutide. I would like to know the limits of what can be inferred from this. What I am trying to avoid is over-reading a single…

hplc
hplc

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

466 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 mass_shift_18 14k · 7 months ago
9 votes 2 answers1.9k views
How do I write up a PeptideMeter result on tirzepatide so it is useful to others?

Conditions: PeptideMeter · tirzepatide. I have done this once and I suspect I got away with it rather than got it right. For context: I keep records of every batch,…

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
harm-reduction
harm-reduction

Reducing avoidable risk where a decision has already been made: independent verification before use, sterility practice, dose arithmetic checked…

445 questions
asked by Dr_Signe_Baldursdottir 46k · 3 months ago
8 votes 5 answers29k views
Does CPC issue lot-specific documentation, or a batch certificate?

The method section is present, which is unusual enough that I want to make use of it. I would like to know the limits of what can be inferred from this. What I am…

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
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 claudia_ferrante 46k · 2.0 years ago
8 votes 5 answers27k views
Would you re-test survodutide after twelve weeks at minus 80 °C, or accept the original certificate?

The case in front of me: survodutide · twelve weeks · minus 80 °C. I want to decide this in advance so that I am not deciding it under pressure later. Assume I will…

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 mateo_iglesias 16k · 22 months ago
8 votes 5 answers25k views
Would you re-test ecnoglutide after twelve weeks at 25 °C, or accept the original certificate?

The case in front of me: ecnoglutide · twelve weeks · 25 °C. I want to decide this in advance so that I am not deciding it under pressure later. Assume I will follow…

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 olu_babatunde 14k · 2.4 years ago
8 votes5 answers25k views
Does ERP issue lot-specific documentation, or a batch certificate?

The lot number on the vial matches the certificate, which at least rules out the easy problem. I have read the primary source rather than the summary, which has left…

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
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 yuki_morishita 19k · 21 months ago
8 votes5 answers21k views
How do I read an HPLC chromatogram beyond the headline number?

The method section is present, which is unusual enough that I want to make use of it. I would like to know the limits of what can be inferred from this. What I am…

hplc
hplc

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

466 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 vial_five 15k · 20 months ago
8 votes 5 answers18k views
Would you re-test dulaglutide after two weeks at 40 °C, or accept the original certificate?

Stated plainly: dulaglutide · two weeks · 40 °C. I am trying to build something sustainable rather than something thorough that I will abandon. I have already decided…

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 otto_brenner 19k · 18 months ago
8 votes 5 answers15k views
How does WXT compare to GL Biochem (Shanghai) on documentation quality?

What I am working with: WXT · GL Biochem (Shanghai). Both of these get recommended confidently by different people, which suggests neither is obviously right. My…

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 mz_4113 99k · 2.3 years ago
8 votes 5 answers12k views
Has anyone independently verified a CPC liraglutide batch COA?

Conditions: CPC · liraglutide. The claim is plausible, which is exactly why I want to check it. I am able to read a paper if someone points me at one. Can anyone…

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 wren_calloway 14k · 9 months ago
8 votes5 answers9.5k views
What does a Karl Fischer water content test add for tirzepatide that a purity figure does not?

Conditions: a Karl Fischer water content test · tirzepatide. These are treated as interchangeable and I do not think they are. If both are acceptable I would like to…

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 Dr_Ilse_Vandenberg 78k · 8 months ago
8 votes 5 answers9.4k views
What does a list of related substances on a GGPeps report change about how I read it?

Conditions: list of related substances · GGPeps. The figures are clear enough; the question is what they mean and what they do not. I can supply the numbers if the…

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 Dr_Otto_Lindqvist 38k · 2.3 years ago
8 votes5 answers7.5k views
What should I make of a dulaglutide certificate that has no batch certificate?

Setup, so nobody has to ask: dulaglutide · batch certificate. I would like help reading this properly rather than being told what conclusion to reach. I have the full…

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 area_percent 13k · 9 months ago
8 votes5 answers6.8k views
Would you re-test tirzepatide after ten weeks at 2–8 °C, or accept the original certificate?

The specifics, since they change the answer: tirzepatide · ten weeks · 2–8 °C. I would like to define my thresholds before I have a result, for obvious reasons. I…

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 oona_kekkonen 16k · 2 months ago
8 votes 5 answers6.4k views
Does SGN issue lot-specific documentation, or a batch certificate?

I have both a purity figure and a content figure, which is why the discrepancy is visible. I can parse the result. I am less sure what it licenses me to conclude. I…

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
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 dana_wexler 15k · 16 months ago
8 votes5 answers5.4k views
A COA says 99.2% purity and 6.1 mg content — is that contradictory?

This is my second independent submission on material from the same supplier. I have the document in front of me and I can read the numbers. What I cannot do is…

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
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
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
asked by otto_brenner 19k · 5 months ago
8 votes 5 answers4.8k views
How do I reconcile 98.4% from PeptideMeter with 98.2% from the supplier?

For reference: 98.4% · PeptideMeter · 98.2%. Something has gone wrong and I would like to know how badly before I decide what to do. Nothing else in the setup…

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 vialroom 87k · 8 months ago
8 votes5 answers4.5k views
What does 97.1% purity on a C8 column actually tell me about a tirzepatide vial?

Numbers first: 97.1% · a C8 column · tirzepatide. This is presented as though it settles something, and I am not convinced it does. I have two documents that appear…

hplc
hplc

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

466 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 sample_id 17k · 2 months ago
8 votes0 answers3.7k views
How many vials from a CPC lot should I send for an HPLC purity test?

The case in front of me: CPC · an HPLC purity test. I want the working, not the result — I need to be able to redo it with different numbers. I care about the…

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 gradient_slope 41k · 9 months ago
8 votes0 answers3k views
How many vials from an SSA lot should I send for an endotoxin test?

For reference: SSA · 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 pascal_thibault 13k · 2 months ago
8 votes 5 answers2.9k views
What does Medutest verification of ChinaPeptides (QYAOBIO) actually cover?

What I am working with: Medutest · ChinaPeptides (QYAOBIO). I would like help reading this properly rather than being told what conclusion to reach. I have the full…

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 rukhsana_iqbal 14k · 38 days ago
8 votes0 answers2.8k views
Does KP issue lot-specific documentation, or a batch certificate?

I have both a purity figure and a content figure, which is why the discrepancy is visible. This is presented as though it settles something, and I am not convinced it…

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
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 coldbox9 13k · 8 months ago
8 votes 4 answers2.7k views
Would you re-test semaglutide after twelve weeks at minus 80 °C, or accept the original certificate?

Concretely: semaglutide · twelve weeks · minus 80 °C. I want to decide this in advance so that I am not deciding it under pressure later. Assume I will follow the…

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 ravi_pillai 16k · 4 months ago
8 votes 5 answers2.3k views
How do I reconcile 98.2% from Janoshik with 97.9% from the supplier?

Numbers first: 98.2% · Janoshik · 97.9%. 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 marta_szymanska 17k · 2 months ago