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batch-testing

Page 10 of 37 · 865 questions tagged batch-testing.

865 questions · sorted by votes · page 10 of 37

27 votes 5 answers30k views
How many vials from a QSC lot should I send for peptide mapping?

Stated plainly: QSC · peptide mapping. The units are where I keep going wrong, so please be explicit about them. I have sanity-checked the order of magnitude and 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
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 void_volume 13k · 12 months ago
27 votes 5 answers30k views
Why did two KP lots of dulaglutide differ on content assay?

What I have: KP · dulaglutide. 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 date, and 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
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 rae_oyelowo 21k · 16 months ago
27 votes 5 answers30k views
Is a 95.2% result from Medutest comparable to 96.8% from PeptideMeter?

Setup, so nobody has to ask: 95.2% · Medutest · 96.8% · PeptideMeter. I suspect the honest answer is that it depends, in which case I would like to know on what.…

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 elke_brunner 14k · 11 months ago
27 votes0 answers27k views
How should I budget for a Karl Fischer water content test across a twelve-month oral semaglutide course?

The case in front of me: a Karl Fischer water content test · oral semaglutide. I want to decide this in advance so that I am not deciding it under pressure later.…

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
janoshik
janoshik

Janoshik Analytical, an independent third-party testing laboratory widely used by this community for HPLC purity, identity and quantified content…

34 questions
asked by triple_agonist_q 37k · 23 months ago
27 votes 5 answers26k views
How do I reconcile 95.2% from VendorInvestigate with 97.9% from the supplier?

The case in front of me: 95.2% · VendorInvestigate · 97.9%. 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 dana_wexler 15k · 10 months ago
27 votes 5 answers25k views
Is a 95.2% result from Medutest comparable to 96.8% from Janoshik?

Setup, so nobody has to ask: 95.2% · Medutest · 96.8% · Janoshik. I suspect the honest answer is that it depends, in which case I would like to know on what. Assume I…

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 k_szabo 45k · 2.0 years ago
27 votes 5 answers25k views
Does a large published testing history at BCH 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 ahmed_zerouali 19k · 10 months ago
27 votes 5 answers23k views
Is an HPLC purity test worth paying for on top of a purity figure for retatrutide?

Numbers first: an HPLC purity test · retatrutide. I would rather over-plan the first cycle and simplify later. I am prepared to do the work if someone can tell me…

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
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
asked by ahmed_zerouali 19k · 7 months ago
27 votes0 answers21k views
What has PeptideMeter published on HJ lots in the last year?

For reference: PeptideMeter · HJ. I have the document in front of me and I can read the numbers. What I cannot do is interpret them. I am reasonably comfortable with…

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 lukas_sedlacek 17k · 11 months ago
27 votes 5 answers20k views
What should I make of a liraglutide certificate that has no list of related substances?

The specifics, since they change the answer: liraglutide · list of related substances. I want to understand what this actually establishes, as opposed to what it 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
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 ahmed_zerouali 19k · 9 months ago
27 votes 5 answers19k views
How many vials from a TFC lot should I send for a sterility test?

Conditions: TFC · 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 number, so 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
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 ayo_fadipe 19k · 16 months ago
27 votes3 answers19k views
Would you re-test orforglipron after eight weeks at 37 °C, or accept the original certificate?

What I am working with: orforglipron · eight weeks · 37 °C. I would like to set this up properly once, rather than adjust it repeatedly. My budget is real but not…

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 aine_mulcahy 35k · 7 months ago
27 votes0 answers17k views
Why would PeptideMeter report 97.6% where the supplier certificate says something higher?

Conditions: PeptideMeter · 97.6%. 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 this 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
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 j_wierzbicki 45k · 22 months ago
27 votes5 answers16k views
My mazdutide vial sat at 37 °C for seven days — is testing worth it before use?

Numbers first: mazdutide · 37 °C · seven days. This is a planning question. I know what my options are; I do not know how to weigh them. What I want is the minimum…

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 priya_menon 11k · 11 months ago
27 votes 5 answers15k views
Is JEEP worth the price difference against Flourishglobal Peptide Biotech on measured results?

Details up front: JEEP · Flourishglobal Peptide Biotech. I have used one of these for a while and I am considering switching, which requires a reason. What I care…

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 bea_forsberg 14k · 19 months ago
27 votes 2 answers15k views
Has anyone independently verified an HJ oral semaglutide batch COA?

Concretely: HJ · oral semaglutide. 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 Dr_Aoife_Brennan 50k · 13 months ago
27 votes5 answers14k views
Why did two WXT lots of mazdutide differ on content assay?

What I am working with: WXT · mazdutide. I noticed this today and I have not touched anything since, in case the state is diagnostic. I have not discarded anything…

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 tobias_reint 19k · 16 months ago
27 votes 5 answers12k views
Why did two TFC lots of tirzepatide differ on content assay?

Conditions: TFC · tirzepatide. I have two candidate explanations and no way to distinguish them. The same procedure has worked without incident several times…

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 t_oyelaran 41k · 8 months ago
27 votes 5 answers7.6k views
Is an endotoxin test worth paying for on top of a purity figure for a GLP-1 receptor agonist?

Stated plainly: an endotoxin test · a GLP-1 receptor agonist. I would like to set this up properly once, rather than adjust it repeatedly. My budget is real but not…

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
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
asked by area_percent 13k · 8 months ago
26 votes 5 answers46k views
How many vials from a JEEP lot should I send for a Karl Fischer water content test?

Numbers first: JEEP · 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 tenth_of_a_unit 40k · 22 months ago
26 votes 5 answers39k views
Would you re-test liraglutide after three weeks at 30 °C, or accept the original certificate?

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

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 per_haugen 18k · 17 months ago
26 votes2 answers38k views
Is QYB worth the price difference against Tianjin Finder Chemical on measured results?

The specifics, since they change the answer: QYB · Tianjin Finder Chemical. I am trying to choose between two options that are usually discussed as though only one…

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 samir_bennani 13k · 20 months ago
26 votes 5 answers35k views
What has Janoshik published on QSC lots in the last year?

What I have: Janoshik · QSC. 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 fill_volume 13k · 17 months ago
26 votes5 answers30k views
Why would Janoshik report 95.2% where the supplier certificate says something higher?

Setup, so nobody has to ask: Janoshik · 95.2%. 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
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 tobias_reint 19k · 12 months ago