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batch-testing

Page 33 of 38 · 910 questions tagged batch-testing.

910 questions · sorted by votes · page 33 of 38

7 votes5 answers20k views
How do I reconcile 97.1% from VendorInvestigate with 98.4% from the supplier?

The case in front of me: 97.1% · VendorInvestigate · 98.4%. 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…

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
vendor-investigate
vendor-investigate

VendorInvestigate, an independent vendor review and verification service. Use this tag for questions about its verification criteria, what a…

113 questions
asked by imani_dube 8.9k · 16 months ago
7 votes 5 answers18k views
Is a 98.2% result from VendorInvestigate comparable to 99.4% from Janoshik?

Concretely: 98.2% · VendorInvestigate · 99.4% · 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…

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
vendor-investigate
vendor-investigate

VendorInvestigate, an independent vendor review and verification service. Use this tag for questions about its verification criteria, what a…

113 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 nine_point_nine 60k · 14 months ago
7 votes 4 answers17k views
Does TFC issue lot-specific documentation, or a batch certificate?

The lot number on the vial matches the certificate, which at least rules out the easy problem. The figures are clear enough; the question is what they mean and what…

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 meniscus_film 32k · 16 months ago
7 votes 5 answers15k views
How do I check that two JEEP lots of dulaglutide agree on content assay?

For reference: JEEP · 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,…

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
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 kelvin_lam 7.6k · 10 months ago
7 votes5 answers12k views
My survodutide vial sat at 40 °C for five days — is testing worth it before use?

Conditions: survodutide · 40 °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…

578 questions
peptide-stability
peptide-stability

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

908 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
survodutide
survodutide

A GLP-1 and glucagon receptor dual agonist with a substantial published MASH dataset. Use this tag for its hepatic endpoints, its dose ladder, and…

225 questions
asked by coring_risk 27k · 14 months ago
7 votes 5 answers9.4k views
What does a method section on a CPC report change about how I read it?

Setup, so nobody has to ask: method section · CPC. 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…

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 swab_and_wait 13k · 12 months ago
7 votes 5 answers8.9k views
Why would Janoshik report 96.8% where the supplier certificate says something higher?

Stated plainly: Janoshik · 96.8%. This is not behaving the way I expected and I want to understand the discrepancy before I act on it. I have photographed the current…

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
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 grainne_ahearn 50k · 17 months ago
7 votes 5 answers8.5k views
Is a 98.4% result from Janoshik comparable to 97.1% from PeptideMeter?

Numbers first: 98.4% · Janoshik · 97.1% · PeptideMeter. I want to know what the trade-off actually is rather than which option is fashionable. I would rather have a…

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
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 orla_sheridan 18k · 8 months ago
7 votes5 answers6.3k views
How do Janoshik and Medutest results compare on the same batch?

This is my second independent submission on material from the same supplier. I have used one of these for a while and I am considering switching, which requires a…

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
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 · 11 months ago
7 votes2 answers5.6k views
Would you re-test ecnoglutide after twelve weeks at room temperature, or accept the original certificate?

Details up front: ecnoglutide · twelve weeks · room temperature. I want to decide this in advance so that I am not deciding it under pressure later. Assume I will…

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
ecnoglutide
ecnoglutide

A long-acting GLP-1 receptor agonist with a cAMP-biased signalling profile. A niche tag, mostly used for mechanism questions about biased agonism…

223 questions
asked by per_haugen 13k · 6 months ago
7 votes 5 answers2.7k views
How do I check that two SGN lots of orforglipron agree on content assay?

The case in front of me: SGN · orforglipron. Before I write this off, I want to check whether it is a known failure mode. I have the lot number, the certificate 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…

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
orforglipron
orforglipron

A non-peptide, orally bioavailable small-molecule GLP-1 receptor agonist studied in the ATTAIN programme. It is not a peptide, which changes…

219 questions
asked by greta_holzmann 23k · 3 months ago
7 votes0 answers2.6k views
What does a list of related substances on a GL Biochem report change about how I read it?

Setup, so nobody has to ask: list of related substances · GL Biochem. The figures are clear enough; the question is what they mean and what they do not. I can supply…

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 retest_please 9.7k · 7 months ago
7 votes 4 answers2.5k views
Why would PeptideMeter report 95.2% where the supplier certificate says something higher?

Concretely: PeptideMeter · 95.2%. 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…

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 kelvin_lam 7.6k · 5 months ago
7 votes 5 answers2.4k views
Is a 97.1% result from VendorInvestigate comparable to 95.2% from PeptideMeter?

The case in front of me: 97.1% · VendorInvestigate · 95.2% · PeptideMeter. I would like the axes of comparison first and the recommendation second. I have tried 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…

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
vendor-investigate
vendor-investigate

VendorInvestigate, an independent vendor review and verification service. Use this tag for questions about its verification criteria, what a…

113 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 orla_sheridan 18k · 3 months ago
7 votes 5 answers2.1k views
Is peptide mapping worth paying for on top of a purity figure for semaglutide?

Details up front: peptide mapping · semaglutide. I would like to define my thresholds before I have a result, for obvious reasons. I want a plan with explicit…

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
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
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
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 ines_delacruz 16k · 5 days ago
6 votes5 answers25k views
Is a 97.9% result from Janoshik comparable to 99.1% from Medutest?

Details up front: 97.9% · Janoshik · 99.1% · 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 tare_and_weigh 12k · 2.4 years ago
6 votes 5 answers22k views
My oral semaglutide vial sat at 40 °C for fourteen days — is testing worth it before use?

For reference: oral semaglutide · 40 °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…

578 questions
peptide-stability
peptide-stability

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

908 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
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 tenth_of_a_unit 57k · 19 months ago
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…

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
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 tobias_reint 20k · 16 months ago
6 votes 5 answers18k views
How do I write up a Medutest result on retatrutide so it is useful to others?

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

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
harm-reduction
harm-reduction

Reducing avoidable risk where a decision has already been made: independent verification before use, sterility practice, dose arithmetic checked…

472 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
retatrutide
retatrutide

An investigational GLP-1, GIP and glucagon receptor tri-agonist, studied in the TRIUMPH programme. Not approved anywhere. Use this tag for…

251 questions
asked by Dr_Malik_Osei 19k · 22 months ago
6 votes 3 answers18k views
Is a 98.8% result from PeptideMeter comparable to 97.9% from Medutest?

The specifics, since they change the answer: 98.8% · PeptideMeter · 97.9% · Medutest. The comparison I want does not seem to exist anywhere in a form I can evaluate.…

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
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
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_Rosalind_Achebe 69k · 20 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?

The particulars: 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…

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…

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
hplc
hplc

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

503 questions
asked by mass_shift_18 9.7k · 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…

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 esther_vandeVelde 52k · 22 months ago
6 votes5 answers14k views
How many vials from a WXT lot should I send for identity confirmation by mass spectrometry?

Concretely: WXT · identity confirmation by mass spectrometry. I have worked this out and I would like someone to find the error, because I suspect there is one. My…

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
mass-spec
mass-spec

Mass spectrometry for identity confirmation: electrospray ionisation, multiple charge states, monoisotopic versus average mass, deconvolution, and…

52 questions
asked by shear_at_the_front 17k · 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…

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 grainne_ahearn 50k · 10 months ago