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batch-testing

Page 13 of 37 · 865 questions tagged batch-testing.

865 questions · sorted by votes · page 13 of 37

24 votes5 answers32k views
My tirzepatide vial sat at 30 °C for fourteen days — is testing worth it before use?

The particulars: tirzepatide · 30 °C · fourteen days. I am at the decision point and I would rather think it through than improvise. I would rather spend money on…

cold-chain
cold-chain

Keeping material within a temperature window from manufacture to use: phase-change packs versus dry ice, thermal mass, transit-lane temperature…

524 questions
peptide-stability
peptide-stability

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

832 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 deamidation_watch 43k · 2.0 years ago
24 votes5 answers31k views
My oral semaglutide vial sat at 30 °C for three days — is testing worth it before use?

The specifics, since they change the answer: oral semaglutide · 30 °C · three days. I would like to define my thresholds before I have a result, for obvious reasons.…

cold-chain
cold-chain

Keeping material within a temperature window from manufacture to use: phase-change packs versus dry ice, thermal mass, transit-lane temperature…

524 questions
peptide-stability
peptide-stability

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

832 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 mg_per_ml 12k · 2.2 years ago
24 votes5 answers24k views
Does testing every lot make sense, or every third lot?

The lot number on the vial matches the certificate, which at least rules out the easy problem. I would like to set this up properly once, rather than adjust 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
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
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 rune_thoresen 14k · 13 months ago
24 votes 5 answers24k views
Is a 98.2% result from Janoshik comparable to 97.9% from Janoshik?

What I have: 98.2% · Janoshik · 97.9% · Janoshik. I have used one of these for a while and I am considering switching, which requires a reason. What I care about is…

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
reference-standard
reference-standard

Certified reference materials and in-house standards: traceability, the certificate of the standard itself, system suitability, and why every…

179 questions
asked by Dr_Otto_Lindqvist 38k · 9 months ago
24 votes 5 answers22k views
Is a 98.4% result from PeptideMeter comparable to 97.1% from PeptideMeter?

The particulars: 98.4% · PeptideMeter · 97.1% · PeptideMeter. The comparison I want does not seem to exist anywhere in a form I can evaluate. I have read 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
reference-standard
reference-standard

Certified reference materials and in-house standards: traceability, the certificate of the standard itself, system suitability, and why every…

179 questions
asked by olu_babatunde 14k · 2.1 years ago
24 votes 5 answers21k views
Is SGN worth the price difference against WuXi TIDES on measured results?

What I have: SGN · WuXi TIDES. I want to know what the trade-off actually is rather than which option is fashionable. I would rather have a defensible reason than a…

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
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
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 cal_hennessy 14k · 14 months ago
24 votes0 answers19k views
Is identity confirmation by mass spectrometry on one vial from a twenty-person split enough for the whole split?

For reference: identity confirmation by mass spectrometry · a twenty-person split. I would like to define my thresholds before I have a result, for obvious reasons. I…

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 jonas_ekstrom 18k · 20 months ago
24 votes0 answers17k views
How do I reconcile 98.4% from Janoshik with 98.2% from the supplier?

Numbers first: 98.4% · Janoshik · 98.2%. 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 rae_oyelowo 21k · 17 months ago
24 votes 5 answers17k views
Does a large published testing history at GL Biochem imply lot consistency?

I have both a purity figure and a content figure, which is why the discrepancy is visible. I would like the mechanism, because I want to be able to reason 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
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
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 fib4_reader 35k · 5 months ago
24 votes 5 answers16k views
How do I write up a Janoshik result on a GLP-1 receptor agonist so it is useful to others?

What I am working with: Janoshik · a GLP-1 receptor agonist. This is a procedural question rather than a theoretical one, and I would like the procedure rather than…

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 second_lot 11k · 5 months ago
24 votes 5 answers16k views
Is a 97.1% result from VendorInvestigate comparable to 96.4% from Janoshik?

Conditions: 97.1% · VendorInvestigate · 96.4% · Janoshik. These are treated as interchangeable and I do not think they are. If both are acceptable I would like 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
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
reference-standard
reference-standard

Certified reference materials and in-house standards: traceability, the certificate of the standard itself, system suitability, and why every…

179 questions
peptidemeter
peptidemeter

PeptideMeter, an independent peptide analytics and vendor-rating service. Use this tag for its published datasets, its rating methodology, and how…

14 questions
asked by mz_4113 99k · 12 months ago
24 votes 5 answers16k views
My semaglutide vial sat at minus 80 °C for five days — is testing worth it before use?

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

cold-chain
cold-chain

Keeping material within a temperature window from manufacture to use: phase-change packs versus dry ice, thermal mass, transit-lane temperature…

524 questions
peptide-stability
peptide-stability

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

832 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 gunnar_isaksen 16k · 4 months ago
24 votes 5 answers14k views
Would you re-test mazdutide after six weeks at room temperature, or accept the original certificate?

Details up front: mazdutide · six weeks · room temperature. This is a planning question. I know what my options are; I do not know how to weigh them. What I want 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
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 · 10 months ago
24 votes 5 answers14k views
Has anyone independently verified a TFC liraglutide batch COA?

The case in front of me: TFC · 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.…

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 jonas_ekstrom 18k · 8 months ago
24 votes2 answers11k views
What does a sampling plan on an FGP report change about how I read it?

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

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 siobhan_deasy 16k · 23 months ago
24 votes 3 answers9.6k views
My ecnoglutide vial sat at minus 20 °C for five days — is testing worth it before use?

The case in front of me: ecnoglutide · minus 20 °C · five days. I want to decide this in advance so that I am not deciding it under pressure later. Assume I will…

cold-chain
cold-chain

Keeping material within a temperature window from manufacture to use: phase-change packs versus dry ice, thermal mass, transit-lane temperature…

524 questions
peptide-stability
peptide-stability

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

832 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 ayo_fadipe 19k · 7 months ago
24 votes 5 answers8.6k views
Is a 99.4% result from VendorInvestigate comparable to 95.2% from Medutest?

Concretely: 99.4% · VendorInvestigate · 95.2% · Medutest. These are treated as interchangeable and I do not think they are. If both are acceptable I would like 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
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
reference-standard
reference-standard

Certified reference materials and in-house standards: traceability, the certificate of the standard itself, system suitability, and why every…

179 questions
asked by day_seven_trough 11k · 3 months ago
24 votes 5 answers8.2k views
Is GGPeps worth the price difference against Hunan Aslsen Technology on measured results?

The particulars: GGPeps · Hunan Aslsen Technology. 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
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
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 aine_mulcahy 35k · 3 months ago
24 votes5 answers8.1k views
Is a lot-specific certificate from SWB sufficient basis to skip independent testing?

Setup, so nobody has to ask: lot-specific certificate · SWB. I am trying to build something sustainable rather than something thorough that I will abandon. I have…

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 orla_ferriter 47k · 8 months ago
24 votes 5 answers6.1k views
My oral semaglutide vial sat at 2–8 °C for three days — is testing worth it before use?

For reference: oral semaglutide · 2–8 °C · three days. I would like to define my thresholds before I have a result, for obvious reasons. I want a plan with explicit…

cold-chain
cold-chain

Keeping material within a temperature window from manufacture to use: phase-change packs versus dry ice, thermal mass, transit-lane temperature…

524 questions
peptide-stability
peptide-stability

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

832 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 rune_thoresen 14k · 6 months ago
24 votes5 answers6k views
How do I reconcile 99.1% from VendorInvestigate with 96.8% from the supplier?

The case in front of me: 99.1% · VendorInvestigate · 96.8%. I have two candidate explanations and no way to distinguish them. The same procedure has worked without…

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 ravenna_pace 13k · 5 months ago
24 votes0 answers4.5k views
What does a list of related substances on an MKM report change about how I read it?

Concretely: list of related substances · MKM. 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 felix_araya 17k · 5 months ago
23 votes 5 answers48k views
What should I make of a survodutide certificate that has no date of analysis?

The case in front of me: survodutide · date of analysis. The figures are clear enough; the question is what they mean and what they do not. I can supply the numbers…

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 mass_shift_18 14k · 2.1 years ago
23 votes5 answers43k views
How many vials from a CPC lot should I send for a sterility test?

The case in front of me: CPC · a sterility test. Please show the division. I want to check my own against yours. I would like the general form as well as the specific…

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 ines_brandt 93k · 23 months ago