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coa

Certificates of analysis: what fields a useful one carries, how to tell a real analytical report from a marketing document, batch and lot traceability, and the single most common trap - reading area-per-cent purity as if it were content.

749 questions · sorted by votes · page 1 of 32

41 votes 5 answers42k views
How do I trace an SWB lot number back to a synthesis date?

This is my second independent submission on material from the same supplier. I can find plenty of assertions about this and almost no reasoning, which is usually a…

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 mira_sundqvist 19k · 22 months ago
41 votes 4 answers39k views
Would you re-test a GLP-1 receptor agonist after sixteen weeks at 30 °C, or accept the original certificate?

What I have: a GLP-1 receptor agonist · sixteen weeks · 30 °C. I would rather over-plan the first cycle and simplify later. I am prepared to do the work if someone…

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 Dr_Priya_Raghunathan 94k · 2.3 years ago
41 votes0 answers38k views
How do I reconcile 99.4% from Janoshik with 97.1% from the supplier?

What I have: 99.4% · Janoshik · 97.1%. 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 colm_dunphy 16k · 23 months ago
41 votes 5 answers27k views
How many vials from a KP lot should I send for a quantified content assay?

Details up front: KP · a quantified content assay. This should be a straightforward calculation and I keep getting two different answers. The numbers are arbitrary;…

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 s_kalniete 47k · 22 months ago
41 votes0 answers26k views
How do I read a liraglutide chromatogram from PeptideMeter beyond the headline number?

The particulars: liraglutide · PeptideMeter. I have the document in front of me and I can read the numbers. What I cannot do is interpret them. I am reasonably…

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 swab_and_wait 15k · 2.2 years ago
40 votes5 answers66k views
What does a certificate with no method section imply?

The lot number on the vial matches the certificate, which at least rules out the easy problem. The figures are clear enough; the question is what they mean and what…

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
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 harriet_lonsdale 14k · 2.4 years ago
40 votes 5 answers60k views
What does Medutest verification of Shanghai Sigma-Audley actually cover?

What I am working with: Medutest · Shanghai Sigma-Audley. I have read the primary source rather than the summary, which has left me with more questions. I understand…

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 ravenna_pace 13k · 2.2 years ago
40 votes 5 answers40k views
Is a date of analysis from HJ sufficient basis to skip independent testing?

For reference: date of analysis · HJ. I would like to define my thresholds before I have a result, for obvious reasons. I want a plan with explicit stopping rules,…

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
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 per_haugen 18k · 19 months ago
40 votes2 answers35k views
What does a 98.2% purity with a lot-specific certificate attached let me conclude?

Numbers first: 98.2% · lot-specific certificate. This is presented as though it settles something, and I am not convinced it does. I have two documents that appear to…

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 birk_nordahl 20k · 19 months ago
40 votes3 answers35k views
What does 97.6% purity on a C18 column actually tell me about an ecnoglutide vial?

Stated plainly: 97.6% · a C18 column · ecnoglutide. I have read the primary source rather than the summary, which has left me with more questions. I understand the…

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 charge_state_3 39k · 21 months ago
40 votes5 answers34k views
What accept/reject threshold would you set for dulaglutide before seeing the result?

The method section is present, which is unusual enough that I want to make use of it. I would like to set this up properly once, rather than adjust it repeatedly. My…

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
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
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 · 2.1 years ago
40 votes5 answers29k views
How do I write up a PeptideMeter result on liraglutide so it is useful to others?

Concretely: PeptideMeter · liraglutide. 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 ruaidhri_o_shea 51k · 2.1 years ago
40 votes 5 answers27k views
How do I reconcile 95.2% from Medutest with 99.4% from the supplier?

What I am working with: 95.2% · Medutest · 99.4%. This is not behaving the way I expected and I want to understand the discrepancy before I act on it. I have…

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 bridget_nyathi 16k · 22 months ago
40 votes 5 answers23k views
Would you re-test retatrutide after two weeks at minus 20 °C, or accept the original certificate?

What I am working with: retatrutide · two weeks · minus 20 °C. I am trying to build something sustainable rather than something thorough that I will abandon. I have…

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 lukas_sedlacek 17k · 2.1 years ago
40 votes5 answers21k views
Is a lot-specific certificate from SGN sufficient basis to skip independent testing?

Stated plainly: lot-specific certificate · SGN. I am trying to build something sustainable rather than something thorough that I will abandon. I have already decided…

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
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 fresh_bac 13k · 23 months ago
39 votes 5 answers76k views
How does MKM compare to Chinese Peptide Company on documentation quality?

The particulars: MKM · Chinese Peptide Company. I am trying to choose between two options that are usually discussed as though only one exists. I am not optimising…

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 bufferline42 49k · 2.1 years ago
39 votes 5 answers66k views
What accept/reject threshold would you set for liraglutide before seeing the result?

I have the report as a PDF with the chromatogram on page two, so I can quote specifics. I am at the decision point and I would rather think it through than improvise.…

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
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
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 sian_llewellyn 85k · 2.3 years ago
39 votes 5 answers61k views
How does KP compare to WuXi TIDES on documentation quality?

What I have: KP · WuXi TIDES. I have used one of these for a while and I am considering switching, which requires a reason. What I care about is reproducibility,…

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 ben_akintola 14k · 2.0 years ago
39 votes 5 answers42k views
How does WWB compare to Shanghai ERP Biotechnology on documentation quality?

Details up front: WWB · Shanghai ERP Biotechnology. I have used one of these for a while and I am considering switching, which requires a reason. What I care about is…

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 pip_okonjo 11k · 20 months ago
39 votes5 answers41k views
How does JEEP compare to Qingdao Sigma Chemical on documentation quality?

What I have: JEEP · Qingdao Sigma Chemical. I want to know what the trade-off actually is rather than which option is fashionable. I would rather have a defensible…

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 orla_sheridan 14k · 2.1 years ago
39 votes 5 answers41k views
Does MKM issue lot-specific documentation, or a batch certificate?

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…

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 coring_risk 17k · 22 months ago
39 votes5 answers37k views
How many vials from a GL Biochem lot should I send for a residual-solvent screen?

For reference: GL Biochem · a residual-solvent screen. I would rather understand the derivation than memorise the outcome. Two people I asked gave two answers that…

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 meniscus_film 34k · 18 months ago
39 votes5 answers37k views
What would you ask Shanghai ERP Biotechnology before a first order that they cannot fake?

I am comparing three suppliers on documentation rather than on price. I have done this once and I suspect I got away with it rather than got it right. For context: 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
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 coldpack_88 37k · 19 months ago
39 votes 5 answers31k views
Is a chromatogram from GGPeps sufficient basis to skip independent testing?

Concretely: chromatogram · GGPeps. The failure mode I am trying to avoid is making this decision emotionally. I have twelve months in view and I would like the plan…

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
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 coring_risk 17k · 19 months ago
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