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batch-testing

Page 20 of 38 · 910 questions tagged batch-testing.

910 questions · sorted by votes · page 20 of 38

19 votes5 answers16k views
Is QSC worth the price difference against Shanghai Sigma-Audley on measured results?

Details up front: QSC · Shanghai Sigma-Audley. I suspect the honest answer is that it depends, in which case I would like to know on what. Assume I can obtain either…

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 esben_lykke 84k · 18 months ago
19 votes5 answers16k views
How do I reconcile 97.1% from Janoshik with 96.8% from the supplier?

Numbers first: 97.1% · Janoshik · 96.8%. 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…

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 colm_dunphy 8.2k · 21 months ago
19 votes0 answers12k views
Is a Karl Fischer water content test worth paying for on top of a purity figure for liraglutide?

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

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
water-content
water-content

Residual moisture in a lyophilised solid, measured by Karl Fischer titration or loss on drying. It drives both the mass balance on a content assay…

51 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 anouk_desmet 16k · 13 months ago
19 votes 5 answers12k views
What should I make of a dulaglutide documentation package that has no sampling plan?

Setup, so nobody has to ask: dulaglutide · sampling plan. I have read the primary source rather than the summary, which has left me with more questions. I understand…

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 tamsin_wray 9.9k · 17 months ago
19 votes0 answers11k views
What does a method section on a QST report change about how I read it?

Conditions: method section · QST. 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…

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 cap_the_luer 14k · 2.3 years ago
19 votes 5 answers9.4k views
How do I write up a Medutest result on dulaglutide so it is useful to others?

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

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
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 m_haraldsen 21k · 9 months ago
19 votes 5 answers9.1k views
Is a 98.2% result from VendorInvestigate comparable to 97.1% from Medutest?

Concretely: 98.2% · VendorInvestigate · 97.1% · Medutest. I would like the axes of comparison first and the recommendation second. I have tried the first option 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
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
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 stopper_core 28k · 16 months ago
19 votes 5 answers8.9k views
How many vials from an SWB lot should I send for a quantified content assay?

What I am working with: SWB · a quantified content assay. This should be a straightforward calculation and I keep getting two different answers. The numbers are…

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
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
asked by leonid_marchuk 19k · 35 days ago
19 votes0 answers8.9k views
What does a method section on an HJ report change about how I read it?

What I have: method section · 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…

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 two_two_micron 9.3k · 9 months ago
19 votes5 answers7.9k views
Is HJ worth the price difference against Guangzhou JEEP Biotechnology on measured results?

Conditions: HJ · Guangzhou JEEP Biotechnology. I would like the axes of comparison first and the recommendation second. I have tried the first option and it works;…

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 bea_forsberg 11k · 11 months ago
19 votes 5 answers7.3k views
My liraglutide vial sat at minus 20 °C for three days — is testing worth it before use?

The specifics, since they change the answer: liraglutide · minus 20 °C · three days. I would like to define my thresholds before I have a result, for obvious reasons.…

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
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 zeynep_arslan 16k · 5 months ago
19 votes0 answers7.1k views
How do Janoshik and Medutest compare on the same semaglutide batch?

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

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
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 per_haugen 13k · 14 months ago
19 votes 5 answers6.4k views
What does a lot-specific certificate on a KP report change about how I read it?

Setup, so nobody has to ask: lot-specific certificate · KP. I have read the primary source rather than the summary, which has left me with more questions. I…

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 nominal_ten 12k · 42 days ago
19 votes 2 answers5.1k views
How do I reconcile 98.2% from PeptideMeter with 96.8% from the supplier?

The particulars: 98.2% · PeptideMeter · 96.8%. 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 ellis_thorne 17k · 9 days ago
19 votes2 answers3.8k views
Is a 99.1% result from PeptideMeter comparable to 98.8% from Medutest?

The particulars: 99.1% · PeptideMeter · 98.8% · Medutest. The comparison I want does not seem to exist anywhere in a form I can evaluate. I have read the arguments…

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 ines_delacruz 16k · 37 days ago
19 votes0 answers2.5k views
Has anyone independently verified an MKM ecnoglutide batch COA?

Details up front: MKM · ecnoglutide. I would like to know whether this claim survives contact with evidence. If the answer is "nobody has tested that", I would like…

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
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 tabular_nums 71k · 2 months ago
18 votes4 answers32k views
Is a 96.8% result from VendorInvestigate comparable to 98.2% from Medutest?

Concretely: 96.8% · VendorInvestigate · 98.2% · Medutest. I would like the axes of comparison first and the recommendation second. I have tried the first option 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
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
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 wren_calloway 23k · 20 months ago
18 votes 5 answers29k views
How many vials from an FGP lot should I send for identity confirmation by mass spectrometry?

Setup, so nobody has to ask: FGP · identity confirmation by mass spectrometry. I have worked this out and I would like someone to find the error, because I suspect…

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 tobias_reint 20k · 2.2 years ago
18 votes5 answers28k views
Why would Janoshik report 96.4% where the supplier certificate says something higher?

What I am working with: Janoshik · 96.4%. I noticed this today and I have not touched anything since, in case the state is diagnostic. I have not discarded anything…

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 assay_blank 45k · 23 months ago
18 votes0 answers21k views
How do I reconcile 96.4% from VendorInvestigate with 99.4% from the supplier?

Conditions: 96.4% · VendorInvestigate · 99.4%. 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…

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 mateo_iglesias 12k · 22 months ago
18 votes5 answers18k views
What would you ask Hubei Jianxiang Bioscience before a first order that they cannot fake?

This is a first order from this supplier, so I have no track record to reason from. Everything I have found on this is either a forum aside or a product page, neither…

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
asked by esben_lykke 84k · 8 months ago
18 votes 5 answers16k views
How do I reconcile 97.1% from VendorInvestigate with 96.4% from the supplier?

The case in front of me: 97.1% · VendorInvestigate · 96.4%. I think I have a problem. I am not yet sure whether it is a real problem or a measurement artefact. I want…

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 ines_delacruz 16k · 8 months ago
18 votes 5 answers15k views
Is a chromatogram from SSA sufficient basis to skip independent testing?

The particulars: chromatogram · SSA. 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…

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
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
asked by rosa_mendieta 8k · 21 months ago
18 votes 5 answers14k views
Why would Janoshik report 98.4% where the supplier certificate says something higher?

What I am working with: Janoshik · 98.4%. I noticed this today and I have not touched anything since, in case the state is diagnostic. I have not discarded anything…

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 void_volume 9.5k · 6 months ago