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batch-testing

Page 19 of 37 · 865 questions tagged batch-testing.

865 questions · sorted by votes · page 19 of 37

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…

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 anouk_desmet 18k · 13 months ago
19 votes 5 answers12k views
What should I make of a dulaglutide certificate that has no sampling plan?

What I am working with: dulaglutide · sampling plan. I have read the primary source rather than the summary, which has left me with more questions. I understand the…

coa
coa

Certificates of analysis: what fields a useful one carries, how to tell a real analytical report from a marketing document, batch and lot…

749 questions
vendor-vetting
vendor-vetting

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

436 questions
batch-testing
batch-testing

Testing at the batch or lot level: sampling plans, how many vials from a lot need testing to say anything about the lot, and the difference…

865 questions
lc-ms
lc-ms

Liquid chromatography coupled to mass spectrometry: separation and identification in one run, and the method of choice when you need to know not…

14 questions
asked by tamsin_wray 13k · 17 months ago
19 votes0 answers11k views
What does a method section on a QST report change about how I read it?

The specifics, since they change the answer: method section · QST. I have the document in front of me and I can read the numbers. What I cannot do is interpret them.…

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
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 cap_the_luer 15k · 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?

Numbers first: Medutest · dulaglutide. 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…

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
harm-reduction
harm-reduction

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

445 questions
asked by m_haraldsen 38k · 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…

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 stopper_core 50k · 16 months ago
19 votes 5 answers8.9k views
How many vials from an SWB lot should I send for a quantified content assay?

Numbers first: SWB · a quantified content assay. This should be a straightforward calculation and I keep getting two different answers. The numbers are arbitrary; the…

batch-testing
batch-testing

Testing at the batch or lot level: sampling plans, how many vials from a lot need testing to say anything about the lot, and the difference…

865 questions
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
lc-ms
lc-ms

Liquid chromatography coupled to mass spectrometry: separation and identification in one run, and the method of choice when you need to know not…

14 questions
asked by leonid_marchuk 15k · 35 days ago
19 votes0 answers8.9k views
What does a method section on an HJ report change about how I read it?

The particulars: 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…

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
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 two_two_micron 15k · 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,…

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
lc-ms
lc-ms

Liquid chromatography coupled to mass spectrometry: separation and identification in one run, and the method of choice when you need to know not…

14 questions
asked by bea_forsberg 14k · 11 months ago
19 votes0 answers7.1k views
How do Janoshik and Medutest compare on the same semaglutide batch?

Stated plainly: 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 obtain…

janoshik
janoshik

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

34 questions
medutest
medutest

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

14 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 per_haugen 18k · 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?

What I am working with: lot-specific certificate · KP. I have read the primary source rather than the summary, which has left me with more questions. I understand the…

coa
coa

Certificates of analysis: what fields a useful one carries, how to tell a real analytical report from a marketing document, batch and lot…

749 questions
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
asked by nominal_ten 14k · 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…

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 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…

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

The particulars: 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…

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 tabular_nums 47k · 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…

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 wren_calloway 14k · 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…

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 tobias_reint 19k · 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…

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 assay_blank 39k · 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…

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 mateo_iglesias 16k · 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…

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 esben_lykke 15k · 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…

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

The case in front of me: 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…

coa
coa

Certificates of analysis: what fields a useful one carries, how to tell a real analytical report from a marketing document, batch and lot…

749 questions
batch-testing
batch-testing

Testing at the batch or lot level: sampling plans, how many vials from a lot need testing to say anything about the lot, and the difference…

865 questions
harm-reduction
harm-reduction

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

445 questions
asked by rosa_mendieta 13k · 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…

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 void_volume 13k · 6 months ago
18 votes 5 answers13k views
Is a 98.4% result from VendorInvestigate comparable to 96.4% from Janoshik?

Conditions: 98.4% · VendorInvestigate · 96.4% · 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…

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 bea_castellanos 47k · 22 months ago
18 votes 4 answers13k views
Has anyone independently verified a KP dulaglutide batch COA?

What I have: KP · dulaglutide. I would rather be corrected now than propagate something wrong. I am specifically not interested in a testimonial; I am interested in a…

vendor-vetting
vendor-vetting

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

436 questions
coa
coa

Certificates of analysis: what fields a useful one carries, how to tell a real analytical report from a marketing document, batch and lot…

749 questions
batch-testing
batch-testing

Testing at the batch or lot level: sampling plans, how many vials from a lot need testing to say anything about the lot, and the difference…

865 questions
asked by kelvin_lam 11k · 6 months ago
18 votes 3 answers11k views
How should I budget for a sterility test across a twelve-month retatrutide course?

Details up front: a sterility test · retatrutide. 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…

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 anja_hellstrom 13k · 7 months ago