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batch-testing

Page 8 of 37 · 865 questions tagged batch-testing.

865 questions · sorted by votes · page 8 of 37

29 votes5 answers30k views
My ecnoglutide vial sat at 37 °C for five days — is testing worth it before use?

Conditions: ecnoglutide · 37 °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 write…

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 Dr_Ravi_Selvarajah 42k · 21 months ago
29 votes3 answers28k views
Why did two CPC lots of tirzepatide differ on content assay?

The case in front of me: CPC · tirzepatide. I think I have a problem. I am not yet sure whether it is a real problem or a measurement artefact. I want to know whether…

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 unit_math 13k · 17 months ago
29 votes 5 answers28k views
Is a 96.8% result from PeptideMeter comparable to 99.4% from PeptideMeter?

The specifics, since they change the answer: 96.8% · PeptideMeter · 99.4% · PeptideMeter. I am trying to choose between two options that are usually discussed as…

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 nine_point_nine 45k · 18 months ago
29 votes 5 answers28k views
How do I reconcile 97.6% from Janoshik with 98.8% from the supplier?

Numbers first: 97.6% · Janoshik · 98.8%. 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 cap_the_luer 15k · 18 months ago
29 votes 5 answers27k views
What has Janoshik published on WXT lots in the last year?

Numbers first: Janoshik · WXT. I can parse the result. I am less sure what it licenses me to conclude. I have deliberately not looked at anyone else’s interpretation…

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
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-comparison
vendor-comparison

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

351 questions
asked by rune_thoresen 14k · 10 months ago
29 votes3 answers26k views
What would you ask Shanghai Wibson Biotechnology before a first order that they cannot fake?

I have certificates from two lots and an independent result on one of them. I can find plenty of assertions about this and almost no reasoning, which is usually a…

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 pieter_maas 22k · 10 months ago
29 votes 5 answers24k views
Does a large published testing history at QSC imply lot consistency?

The lot number on the vial matches the certificate, which at least rules out the easy problem. I keep seeing this stated as a fact with no explanation attached, 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
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 mira_sundqvist 19k · 16 months ago
29 votes 5 answers22k views
What should I make of a retatrutide certificate that has no sampling plan?

What I am working with: retatrutide · sampling plan. I have read the primary source rather than the summary, which has left me with more questions. I understand 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
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 lucia_marchetti 18k · 19 months ago
29 votes 5 answers21k views
Has anyone independently verified a WXT a GLP-1 receptor agonist batch COA?

Setup, so nobody has to ask: WXT · a GLP-1 receptor agonist. This is asserted often enough that I assumed it was established, and then I went looking for the source.…

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 sunniva_dahl 11k · 14 months ago
29 votes 5 answers21k views
How do I trace a QSC lot number back to a synthesis date?

The lot number on the vial matches the certificate, which at least rules out the easy problem. Everything I have found on this is either a forum aside or a product…

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 pascal_thibault 13k · 12 months ago
29 votes5 answers20k views
Is a batch certificate from BCH sufficient basis to skip independent testing?

Details up front: batch certificate · BCH. I would rather over-plan the first cycle and simplify later. I am prepared to do the work if someone can tell me which work…

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 otto_brenner 19k · 8 months ago
29 votes0 answers18k views
Does a large published testing history at MKM 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 loss_on_drying 47k · 9 months ago
29 votes 3 answers18k views
How do I reconcile 97.1% from Medutest with 96.8% from the supplier?

Setup, so nobody has to ask: 97.1% · Medutest · 96.8%. I noticed this today and I have not touched anything since, in case the state is diagnostic. I have not…

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 anja_hellstrom 13k · 20 months ago
29 votes0 answers17k views
Is a chromatogram from QYB sufficient basis to skip independent testing?

The case in front of me: chromatogram · QYB. The failure mode I am trying to avoid is making this decision emotionally. I have twelve months in view and I would like…

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 Dr_Ravi_Selvarajah 42k · 15 months ago
29 votes 5 answers14k views
What should I make of a semaglutide certificate that has no method section?

The case in front of me: semaglutide · method section. I would like to know the limits of what can be inferred from this. What I am trying to avoid is over-reading a…

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 retest_please 13k · 12 months ago
29 votes 5 answers12k views
Why did two SWB lots of dulaglutide differ on content assay?

Numbers first: SWB · dulaglutide. I have a result I cannot explain, and I would rather diagnose it than guess. I have checked the obvious explanations and eliminated…

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 thabo_maseko 20k · 15 months ago
29 votes 3 answers11k views
Bioburden, sterility and endotoxin are three different tests — what does each one actually prove?

A COA I was sent lists "Sterility: Sterile filtered (0.22 um)" and nothing else microbiological. Another lists "Bioburden: less than 10 CFU/g — Pass". A third lists…

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
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
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_sheridan 14k · 23 months ago
28 votes5 answers53k views
How many vials from an SWB lot should I send for a Karl Fischer water content test?

Numbers first: SWB · 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 wren_calloway 14k · 2.1 years ago
28 votes5 answers48k views
Has anyone independently verified an MKM survodutide batch COA?

The specifics, since they change the answer: MKM · survodutide. Somebody stated this to me confidently and I would like to check it before repeating it. I would…

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 rae_oyelowo 21k · 2.1 years ago
28 votes5 answers48k views
Would you re-test cagrilintide after sixteen weeks at minus 20 °C, or accept the original certificate?

Numbers first: cagrilintide · sixteen weeks · minus 20 °C. I would rather over-plan the first cycle and simplify later. I am prepared to do the work if someone can…

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 marta_szymanska 17k · 2.3 years ago
28 votes 5 answers44k views
Is peptide mapping on one vial from a twenty-person split enough for the whole split?

The particulars: peptide mapping · a twenty-person split. I am at the decision point and I would rather think it through than improvise. I would rather spend money on…

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 rae_oyelowo 21k · 2.2 years ago
28 votes 5 answers42k views
Has anyone independently verified a KP retatrutide batch COA?

Numbers first: KP · retatrutide. I would rather be corrected now than propagate something wrong. I am specifically not interested in a testimonial; I am interested in…

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 rune_thoresen 14k · 20 months ago
28 votes 5 answers33k views
How many vials from an SSA lot should I send for a residual-solvent screen?

The specifics, since they change the answer: SSA · a residual-solvent screen. I would rather understand the derivation than memorise the outcome. Two people I asked…

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 j_wierzbicki 45k · 12 months ago
28 votes 4 answers26k views
What would you ask Shanghai Sigma-Audley before a first order that they cannot fake?

I have certificates from two lots and an independent result on one of them. I want a method I can write down and repeat, not a rule of thumb. I would rather…

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 leah_ferrers 15k · 11 months ago