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batch-testing

Page 4 of 37 · 865 questions tagged batch-testing.

865 questions · sorted by votes · page 4 of 37

35 votes 4 answers42k views
How do I reconcile 98.8% from PeptideMeter with 97.9% from the supplier?

The specifics, since they change the answer: 98.8% · PeptideMeter · 97.9%. An unexpected observation, and I would like a differential rather than reassurance. 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…

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 net_peptide 16k · 22 months ago
35 votes 5 answers41k views
Does GL Biochem 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 have the document in front of me and I can read the numbers. What I…

batch-testing
batch-testing

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

865 questions
coa
coa

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

749 questions
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 syringe_ninety 15k · 20 months ago
35 votes 5 answers29k views
How do I reconcile 99.4% from PeptideMeter with 97.1% from the supplier?

The particulars: 99.4% · PeptideMeter · 97.1%. 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…

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 Dr_Rosalind_Achebe 90k · 20 months ago
35 votes0 answers29k views
Does BCH issue lot-specific documentation, or a batch certificate?

I am comparing a supplier certificate against an independent result on the same lot. I have read the primary source rather than the summary, which has left me with…

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
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 second_lot 11k · 15 months ago
35 votes 5 answers16k views
How do I trace an ERP lot number back to a synthesis date?

The method section is present, which is unusual enough that I want to make use of it. This is a procedural question rather than a theoretical one, and I would like…

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
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 seven_day_half 16k · 19 months ago
35 votes 3 answers16k views
Two labs reported 98.1% and 99.4% on the same vial. Which one is wrong?

I split one vial and sent halves to two independent laboratories. Purity came back 98.1% and 99.4%. Both sent chromatograms. Both look competent. The 1.3-point gap is…

hplc
hplc

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

466 questions
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
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
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 noor_alhassan 15k · 12 months ago
35 votes0 answers12k views
Is a chromatogram from GL Biochem sufficient basis to skip independent testing?

Concretely: chromatogram · GL Biochem. The failure mode I am trying to avoid is making this decision emotionally. I have twelve months in view and I would like 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
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 Dr_Fatima_Belkacem 52k · 17 months ago
34 votes 5 answers59k views
Is QSC worth the price difference against Xi’an Mokemei Biotechnology on measured results?

Stated plainly: QSC · Xi’an Mokemei Biotechnology. Both of these get recommended confidently by different people, which suggests neither is obviously right. My…

vendor-comparison
vendor-comparison

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

351 questions
cost-analysis
cost-analysis

Cost arithmetic done honestly: cost per milligram after dead-space loss, list versus net price, comparing a multi-dose vial to a fixed-dose pen,…

261 questions
batch-testing
batch-testing

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

865 questions
asked by tare_weight 47k · 2.1 years ago
34 votes5 answers56k views
Why would Janoshik report 97.6% where the supplier certificate says something higher?

Setup, so nobody has to ask: Janoshik · 97.6%. I noticed this today and I have not touched anything since, in case the state is diagnostic. I have not discarded…

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 cold_lane 14k · 23 months ago
34 votes 5 answers49k views
How do I trace a WWB lot number back to a synthesis date?

I have both a purity figure and a content figure, which is why the discrepancy is visible. I would like to understand the steps well enough to explain them to someone…

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
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 ekaterina_volk 16k · 17 months ago
34 votes 5 answers46k views
Is a 97.9% result from Medutest comparable to 98.8% from Janoshik?

Setup, so nobody has to ask: 97.9% · Medutest · 98.8% · Janoshik. Both of these get recommended confidently by different people, which suggests neither is obviously…

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 ayo_fadipe 19k · 18 months ago
34 votes 5 answers44k views
Is HJ worth the price difference against Zhuhai Kerui Biotechnology on measured results?

Concretely: HJ · Zhuhai Kerui Biotechnology. These are treated as interchangeable and I do not think they are. If both are acceptable I would like to know that, so I…

vendor-comparison
vendor-comparison

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

351 questions
cost-analysis
cost-analysis

Cost arithmetic done honestly: cost per milligram after dead-space loss, list versus net price, comparing a multi-dose vial to a fixed-dose pen,…

261 questions
batch-testing
batch-testing

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

865 questions
asked by plunger_stop 18k · 20 months ago
34 votes 5 answers43k views
How many vials from a BCH lot should I send for identity confirmation by mass spectrometry?

Setup, so nobody has to ask: BCH · 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 fresh_bac 13k · 18 months ago
34 votes 5 answers43k views
What does a lot-specific certificate on a WWB report change about how I read it?

What I am working with: lot-specific certificate · WWB. 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…

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 esther_vandeVelde 49k · 2.2 years ago
34 votes0 answers43k views
Is a Karl Fischer water content test on one vial from a two-person split enough for the whole split?

Conditions: a Karl Fischer water content test · a two-person split. The failure mode I am trying to avoid is making this decision emotionally. I have twelve months in…

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…

865 questions
coa
coa

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

749 questions
asked by dana_wexler 15k · 22 months ago
34 votes0 answers42k views
Does Medutest test the vial or accept the vendor’s sample?

The method section is present, which is unusual enough that I want to make use of it. This has the shape of a fact but I cannot find its origin. What I found instead…

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
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 s_kalniete 47k · 21 months ago
34 votes 5 answers40k views
Why would Janoshik report 99.1% where the supplier certificate says something higher?

Setup, so nobody has to ask: Janoshik · 99.1%. I noticed this today and I have not touched anything since, in case the state is diagnostic. I have not discarded…

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 nynke_dekker 18k · 17 months ago
34 votes5 answers40k views
Why would VendorInvestigate report 97.6% where the supplier certificate says something higher?

The particulars: VendorInvestigate · 97.6%. An unexpected observation, and I would like a differential rather than reassurance. The conditions were within what I…

purity
purity

Purity as chromatographic area per cent - the fraction of detected material that is your target peak. It says nothing about how much material is…

788 questions
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 priya_menon 11k · 17 months ago
34 votes5 answers40k views
How many vials from a TFC lot should I send for an HPLC purity test?

Concretely: TFC · 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 as…

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 mz_4113 99k · 2.1 years ago
34 votes 5 answers38k views
How many vials from a QSC lot should I send for identity confirmation by mass spectrometry?

Setup, so nobody has to ask: QSC · 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 seven_day_half 16k · 16 months ago
34 votes 5 answers36k views
Is an endotoxin test worth paying for on top of a purity figure for cagrilintide?

Setup, so nobody has to ask: an endotoxin test · cagrilintide. I would like to set this up properly once, rather than adjust it repeatedly. My budget is real but not…

content-assay
content-assay

Quantified content: how many milligrams of peptide are actually in the vial, measured against a calibrated reference standard. A separate test…

438 questions
batch-testing
batch-testing

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

865 questions
cost-analysis
cost-analysis

Cost arithmetic done honestly: cost per milligram after dead-space loss, list versus net price, comparing a multi-dose vial to a fixed-dose pen,…

261 questions
asked by mala_venkatesh 21k · 18 months ago
34 votes 1 answer14k views
Would you re-test oral semaglutide after ten weeks at minus 20 °C, or accept the original certificate?

The particulars: oral semaglutide · ten weeks · minus 20 °C. I would like to define my thresholds before I have a result, for obvious reasons. I want a plan with…

batch-testing
batch-testing

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

865 questions
peptide-stability
peptide-stability

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

832 questions
coa
coa

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

749 questions
asked by charge_state_3 39k · 13 months ago
34 votes5 answers13k views
Why would Medutest report 98.4% where the supplier certificate says something higher?

Details up front: Medutest · 98.4%. 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,…

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 jonas_ekstrom 18k · 14 months ago
33 votes5 answers52k views
My survodutide vial sat at 37 °C for twenty-one days — is testing worth it before use?

Concretely: survodutide · 37 °C · twenty-one days. The failure mode I am trying to avoid is making this decision emotionally. I have twelve months in view and I would…

cold-chain
cold-chain

Keeping material within a temperature window from manufacture to use: phase-change packs versus dry ice, thermal mass, transit-lane temperature…

524 questions
peptide-stability
peptide-stability

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

832 questions
batch-testing
batch-testing

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

865 questions
asked by threadlock7 14k · 19 months ago