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batch-testing

Page 32 of 38 · 910 questions tagged batch-testing.

910 questions · sorted by votes · page 32 of 38

8 votes 5 answers18k views
Would you re-test dulaglutide after two weeks at 40 °C, or accept the original certificate?

Stated plainly: dulaglutide · two weeks · 40 °C. I am trying to build something sustainable rather than something thorough that I will abandon. I have already decided…

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…

910 questions
peptide-stability
peptide-stability

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

908 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…

771 questions
dulaglutide
dulaglutide

A once-weekly GLP-1 receptor agonist built on an Fc fusion rather than fatty-acid acylation. Use this tag for questions about the fusion-protein…

200 questions
asked by otto_brenner 12k · 18 months ago
8 votes 5 answers16k views
How should I budget for a quantified content assay across a twelve-month oral semaglutide course?

Setup, so nobody has to ask: a quantified content assay · oral semaglutide. The failure mode I am trying to avoid is making this decision emotionally. I have twelve…

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…

910 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,…

260 questions
janoshik
janoshik

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

139 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…

476 questions
oral-glp1
oral-glp1

Oral routes for GLP-1 receptor agonism: peptide formulations rescued by absorption enhancers such as SNAC, and true small molecules that need no…

219 questions
asked by kofi_mensah 18k · 22 months ago
8 votes 5 answers16k views
How do I check that two ERP lots of a GLP-1 receptor agonist agree on content assay?

Stated plainly: ERP · a GLP-1 receptor agonist. This is not behaving the way I expected and I want to understand the discrepancy before I act on it. 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…

910 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…

476 questions
vendor-vetting
vendor-vetting

Evaluating a supplier on evidence rather than reputation: testing history across batches, whether certificates are batch-specific, how failures…

454 questions
asked by mass_shift_18 9.7k · 2.1 years ago
8 votes5 answers15k views
Is MKM worth the price difference against Tianjin Finder Chemical on measured results?

Stated plainly: MKM · Tianjin Finder Chemical. I am trying to choose between two options that are usually discussed as though only one exists. I am not optimising for…

vendor-comparison
vendor-comparison

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

388 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,…

260 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…

910 questions
asked by juliette_farnese 13k · 13 months ago
8 votes5 answers15k views
Is a 96.4% result from Medutest comparable to 97.6% from Janoshik?

What I am working with: 96.4% · Medutest · 97.6% · Janoshik. I suspect the honest answer is that it depends, in which case I would like to know on what. Assume I can…

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…

833 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…

910 questions
reference-standard
reference-standard

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

185 questions
medutest
medutest

Medutest, one of four independent testing and verification services referenced throughout this site. Use this tag for its methods, its report…

126 questions
janoshik
janoshik

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

139 questions
asked by per_haugen 13k · 20 months ago
8 votes 5 answers12k views
How do I check that two MKM lots of semaglutide agree on content assay?

Concretely: MKM · semaglutide. An unexpected observation, and I would like a differential rather than reassurance. The conditions were within what I understood to be…

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…

910 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…

476 questions
vendor-vetting
vendor-vetting

Evaluating a supplier on evidence rather than reputation: testing history across batches, whether certificates are batch-specific, how failures…

454 questions
semaglutide
semaglutide

A GLP-1 receptor agonist with a fatty-acid-acylated backbone and a roughly one-week half-life, marketed for type 2 diabetes and for weight…

470 questions
asked by lucia_marchetti 19k · 8 months ago
8 votes 5 answers12k views
Has anyone independently verified a CPC liraglutide batch COA?

The specifics, since they change the answer: CPC · liraglutide. The claim is plausible, which is exactly why I want to check it. I am able to read a paper if someone…

vendor-vetting
vendor-vetting

Evaluating a supplier on evidence rather than reputation: testing history across batches, whether certificates are batch-specific, how failures…

454 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…

771 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…

910 questions
liraglutide
liraglutide

A once-daily GLP-1 receptor agonist and the compound that established the class. Still relevant for its shorter half-life, its paediatric and…

235 questions
asked by wren_calloway 23k · 9 months ago
8 votes 5 answers9.4k views
What does a list of related substances on a GGPeps report change about how I read it?

The case in front of me: list of related substances · GGPeps. The figures are clear enough; the question is what they mean and what they do not. I can supply 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…

771 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…

910 questions
vendor-vetting
vendor-vetting

Evaluating a supplier on evidence rather than reputation: testing history across batches, whether certificates are batch-specific, how failures…

454 questions
asked by Dr_Otto_Lindqvist 72k · 2.3 years ago
8 votes 4 answers7.7k views
Is a 96.4% result from Janoshik comparable to 95.2% from Medutest?

Details up front: 96.4% · Janoshik · 95.2% · Medutest. I have used one of these for a while and I am considering switching, which requires a reason. What I care about…

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…

833 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…

910 questions
reference-standard
reference-standard

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

185 questions
janoshik
janoshik

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

139 questions
medutest
medutest

Medutest, one of four independent testing and verification services referenced throughout this site. Use this tag for its methods, its report…

126 questions
asked by Dr_Tomas_Kral 53k · 14 months ago
8 votes5 answers7.5k views
What should I make of a dulaglutide documentation package that has no batch certificate?

The particulars: dulaglutide · batch certificate. I would like help reading this properly rather than being told what conclusion to reach. I have the full report…

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…

771 questions
vendor-vetting
vendor-vetting

Evaluating a supplier on evidence rather than reputation: testing history across batches, whether certificates are batch-specific, how failures…

454 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…

910 questions
dulaglutide
dulaglutide

A once-weekly GLP-1 receptor agonist built on an Fc fusion rather than fatty-acid acylation. Use this tag for questions about the fusion-protein…

200 questions
asked by area_percent 9.9k · 9 months ago
8 votes5 answers7k views
Is Homopeptide worth the price difference against Sangon Biotech (Shanghai) on measured results?

Stated plainly: Homopeptide · Sangon Biotech (Shanghai). These are treated as interchangeable and I do not think they are. If both are acceptable I would like to know…

vendor-comparison
vendor-comparison

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

388 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,…

260 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…

910 questions
asked by Dr_Marek_Zielinski 27k · 3 months ago
8 votes5 answers6.8k views
Would you re-test tirzepatide after ten weeks at 2–8 °C, or accept the original certificate?

The specifics, since they change the answer: tirzepatide · ten weeks · 2–8 °C. I would like to define my thresholds before I have a result, for obvious reasons. 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…

910 questions
peptide-stability
peptide-stability

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

908 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…

771 questions
tirzepatide
tirzepatide

A dual GIP and GLP-1 receptor agonist. Questions here cover the SURPASS and SURMOUNT programmes, the practical differences from a pure GLP-1…

370 questions
asked by oona_kekkonen 13k · 2 months ago
8 votes 5 answers6.4k views
Does SGN 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 can parse the result. I am less sure what it licenses me to conclude. 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…

910 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…

771 questions
vendor-vetting
vendor-vetting

Evaluating a supplier on evidence rather than reputation: testing history across batches, whether certificates are batch-specific, how failures…

454 questions
asked by dana_wexler 11k · 16 months ago
8 votes 5 answers6k views
Is QST worth the price difference against Sangon Biotech (Shanghai) on measured results?

Details up front: QST · Sangon Biotech (Shanghai). These are treated as interchangeable and I do not think they are. If both are acceptable I would like to know that,…

vendor-comparison
vendor-comparison

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

388 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,…

260 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…

910 questions
asked by Dr_Tomas_Kral 53k · 8 months ago
8 votes5 answers4.9k views
How do I check that two TFC lots of liraglutide agree on content assay?

Concretely: TFC · liraglutide. 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…

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…

910 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…

476 questions
vendor-vetting
vendor-vetting

Evaluating a supplier on evidence rather than reputation: testing history across batches, whether certificates are batch-specific, how failures…

454 questions
liraglutide
liraglutide

A once-daily GLP-1 receptor agonist and the compound that established the class. Still relevant for its shorter half-life, its paediatric and…

235 questions
asked by ahmed_zerouali 15k · 4 months ago
8 votes 5 answers4.8k views
How do I reconcile 98.4% from PeptideMeter with 98.2% from the supplier?

For reference: 98.4% · PeptideMeter · 98.2%. 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…

833 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…

910 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…

771 questions
peptidemeter
peptidemeter

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

107 questions
asked by laminar_bench 69k · 8 months ago
8 votes3 answers3.9k views
Why would PeptideMeter report 99.4% where the supplier certificate says something higher?

The case in front of me: PeptideMeter · 99.4%. I have two candidate explanations and no way to distinguish them. The same procedure has worked without incident…

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…

833 questions
hplc
hplc

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

503 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…

910 questions
peptidemeter
peptidemeter

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

107 questions
asked by lipid_panel_q 36k · 20 days ago
8 votes0 answers3.8k views
Is CPC worth the price difference against Sangon Biotech (Shanghai) on measured results?

Details up front: CPC · Sangon Biotech (Shanghai). I would like the axes of comparison first and the recommendation second. I have tried the first option and it…

vendor-comparison
vendor-comparison

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

388 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,…

260 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…

910 questions
asked by sample_id 17k · 8 months ago
8 votes0 answers3.7k views
How many vials from a CPC lot should I send for an HPLC purity test?

What I have: CPC · an HPLC purity test. I want the working, not the result — I need to be able to redo it with different numbers. I care about the precision as well…

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…

910 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…

771 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,…

260 questions
hplc
hplc

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

503 questions
asked by gradient_slope 46k · 9 months ago
8 votes0 answers3k views
How many vials from an SSA lot should I send for an endotoxin test?

The particulars: SSA · an endotoxin test. I would like the arithmetic checked rather than the conclusion asserted. I have deliberately not used an online calculator…

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…

910 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…

771 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,…

260 questions
endotoxin
endotoxin

Bacterial endotoxin: LAL and kinetic chromogenic methods, how an endotoxin limit is derived from a dose, why endotoxin survives autoclaving, and…

23 questions
asked by pascal_thibault 11k · 2 months ago
8 votes0 answers2.8k views
Does KP 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. This is presented as though it settles something, and I am not convinced 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…

910 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…

771 questions
vendor-vetting
vendor-vetting

Evaluating a supplier on evidence rather than reputation: testing history across batches, whether certificates are batch-specific, how failures…

454 questions
asked by coldbox9 41k · 8 months ago
8 votes 4 answers2.7k views
Would you re-test semaglutide after twelve weeks at minus 80 °C, or accept the original certificate?

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

910 questions
peptide-stability
peptide-stability

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

908 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…

771 questions
semaglutide
semaglutide

A GLP-1 receptor agonist with a fatty-acid-acylated backbone and a roughly one-week half-life, marketed for type 2 diabetes and for weight…

470 questions
asked by ravi_pillai 12k · 4 months ago
8 votes 5 answers2.3k views
How do I reconcile 98.2% from Janoshik with 97.9% from the supplier?

Numbers first: 98.2% · Janoshik · 97.9%. I have a result I cannot explain, and I would rather diagnose it than guess. I have checked the obvious explanations and…

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…

833 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…

910 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…

771 questions
janoshik
janoshik

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

139 questions
asked by marta_szymanska 10k · 2 months ago
8 votes0 answers1.9k views
How many vials from a BCH lot should I send for peptide mapping?

Details up front: BCH · 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…

910 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…

771 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,…

260 questions
peptide-mapping
peptide-mapping

Enzymatic digestion followed by LC-MS/MS to confirm sequence rather than just mass. The method that catches a scrambled sequence or a D-amino-acid…

103 questions
asked by void_volume 9.5k · 4 months ago