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batch-testing

Page 32 of 37 · 865 questions tagged batch-testing.

865 questions · sorted by votes · page 32 of 37

6 votes 5 answers21k views
Would you re-test liraglutide after ten weeks at 30 °C, or accept the original certificate?

The particulars: liraglutide · ten weeks · 30 °C. I would like to define my thresholds before I have a result, for obvious reasons. I want a plan with explicit…

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 tobias_reint 19k · 16 months ago
6 votes 5 answers18k views
How do I write up a Medutest result on retatrutide so it is useful to others?

Details up front: Medutest · retatrutide. I can find plenty of assertions about this and almost no reasoning, which is usually a sign that nobody has checked. Assume…

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_Malik_Osei 37k · 22 months ago
6 votes 5 answers17k views
Is an HPLC purity test on one vial from a five-person group buy enough for the whole split?

What I have: an HPLC purity test · a five-person group buy. This is a planning question. I know what my options are; I do not know how to weigh them. What I want 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 mass_shift_18 14k · 2.1 years ago
6 votes5 answers15k views
How do I reconcile 97.9% from PeptideMeter with 99.1% from the supplier?

The particulars: 97.9% · PeptideMeter · 99.1%. 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 esther_vandeVelde 49k · 22 months ago
6 votes5 answers14k views
How many vials from a WXT lot should I send for identity confirmation by mass spectrometry?

What I am working with: WXT · identity confirmation by mass spectrometry. I have worked this out and I would like someone to find the error, because I suspect there…

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 shear_at_the_front 15k · 10 months ago
6 votes 5 answers12k views
Does Homopeptide issue lot-specific documentation, or a batch certificate?

I am comparing a supplier certificate against an independent result on the same lot. 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 grainne_ahearn 13k · 10 months ago
6 votes5 answers9.9k views
Would you re-test orforglipron after two weeks at 40 °C, or accept the original certificate?

Setup, so nobody has to ask: orforglipron · two weeks · 40 °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 one_ml_bac 12k · 8 months ago
6 votes4 answers8.6k views
How many vials from a GGPeps lot should I send for an endotoxin test?

The specifics, since they change the answer: GGPeps · an endotoxin test. I would like the arithmetic checked rather than the conclusion asserted. I have deliberately…

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 cold_lane 14k · 17 months ago
6 votes 5 answers7.3k views
Is KP worth the price difference against WuXi TIDES on measured results?

Numbers first: KP · 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 forty_units 14k · 22 months ago
6 votes 5 answers6.9k views
What should I make of a mazdutide certificate that has no lot-specific certificate?

Details up front: mazdutide · lot-specific certificate. I can parse the result. I am less sure what it licenses me to conclude. I have deliberately not looked at…

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 swab_stopper 16k · 20 months ago
6 votes0 answers5.5k views
What does a method section on a Homopeptide report change about how I read it?

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

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 meniscus_film 34k · 15 months ago
6 votes0 answers5.3k views
What does a date of analysis on a QST report change about how I read it?

For reference: date of analysis · QST. I want to understand what this actually establishes, as opposed to what it is being used to imply. My concern is that I am…

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 syringe_ninety 15k · 21 months ago
6 votes5 answers5.3k views
Would you re-test survodutide after four weeks at minus 20 °C, or accept the original certificate?

The case in front of me: survodutide · four weeks · minus 20 °C. The failure mode I am trying to avoid is making this decision emotionally. I have twelve months in…

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 rota_site 55k · 2 months ago
6 votes5 answers5.1k views
What is the per-participant cost in a five-person group buy once testing is included?

I am comparing three suppliers on documentation rather than on price. I have worked this out and I would like someone to find the error, because I suspect there 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
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 grainne_ahearn 13k · 8 months ago
6 votes4 answers5.1k views
Why would VendorInvestigate report 96.4% where the supplier certificate says something higher?

For reference: VendorInvestigate · 96.4%. Something has gone wrong and I would like to know how badly before I decide what to do. Nothing else in the setup changed,…

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
hplc
hplc

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

466 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 rhian_prydderch 44k · 5 months ago
6 votes0 answers5.1k views
How do I trace a QYB lot number back to a synthesis date?

I have the report as a PDF with the chromatogram on page two, so I can quote specifics. I want a method I can write down and repeat, not a rule of thumb. I would…

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 ben_akintola 14k · 19 months ago
6 votes 4 answers4.9k views
How do I trace a GGPeps lot number back to a synthesis date?

I have the report as a PDF with the chromatogram on page two, so I can quote specifics. I want a method I can write down and repeat, not a rule of thumb. I would…

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 Dr_Aoife_Brennan 50k · 5 months ago
6 votes 5 answers4.7k views
How do I trace a TFC lot number back to a synthesis date?

The method section is present, which is unusual enough that I want to make use of it. I am trying to do this correctly the first time rather than learn it by getting…

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 loss_on_drying 47k · 32 days ago
6 votes 5 answers4.7k views
Why did two ERP lots of cagrilintide differ on content assay?

What I am working with: ERP · cagrilintide. This is not behaving the way I expected and I want to understand the discrepancy before I act on it. I have photographed…

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
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
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 label_claim 11k · 11 months ago
6 votes 5 answers4.5k views
Is a chromatogram from MKM sufficient basis to skip independent testing?

Conditions: chromatogram · MKM. 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 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
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 threadlock7 14k · 9 months ago
6 votes5 answers3.4k views
Why does my independent result sit 0.6% below the supplier certificate?

I have the report as a PDF with the chromatogram on page two, so I can quote specifics. Something has gone wrong and I would like to know how badly before I decide…

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
hplc
hplc

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

466 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 second_lot 11k · 5 months ago
6 votes 4 answers3.3k views
Does FGP 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 help reading this properly rather than being told what conclusion…

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 label_claim 11k · 4 months ago
6 votes0 answers3.1k views
Does QYB 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 have the document in front of me and I can read the numbers. What 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 Dr_Fatima_Belkacem 52k · 15 months ago
6 votes 1 answer2.9k views
How many vials from a KP lot should I send for a Karl Fischer water content test?

Numbers first: KP · 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 this…

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_delacruz 16k · 4 months ago