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batch-testing

Page 24 of 37 · 865 questions tagged batch-testing.

865 questions · sorted by votes · page 24 of 37

15 votes0 answers5.4k views
How should I budget for an endotoxin test across a twelve-month cagrilintide course?

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…

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 liam_bracken 12k · 6 months ago
15 votes0 answers5k views
Would you re-test ecnoglutide after four weeks at 4 °C, or accept the original certificate?

The case in front of me: ecnoglutide · four weeks · 4 °C. The failure mode I am trying to avoid is making this decision emotionally. I have twelve months in view 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…

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 tare_weight 47k · 3 months ago
15 votes 2 answers3.9k views
How do I reconcile 98.2% from PeptideMeter with 99.4% from the supplier?

The specifics, since they change the answer: 98.2% · PeptideMeter · 99.4%. Something has gone wrong and I would like to know how badly before I decide what to do.…

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 mass_shift_18 14k · 5 months ago
15 votes5 answers2.9k views
Has anyone independently verified a BCH mazdutide batch COA?

Stated plainly: BCH · mazdutide. This has the shape of a fact but I cannot find its origin. What I found instead were three secondary sources all citing each other.…

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 rune_thoresen 14k · 34 days ago
15 votes4 answers2.6k views
Why would PeptideMeter report 98.2% where the supplier certificate says something higher?

The case in front of me: PeptideMeter · 98.2%. I have two candidate explanations and no way to distinguish them. The same procedure has worked without incident…

purity
purity

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

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 seamus_brady 17k · 3 months ago
14 votes 5 answers35k views
How should I budget for an HPLC purity test across a twelve-month retatrutide course?

Numbers first: an HPLC purity test · retatrutide. I would rather over-plan the first cycle and simplify later. I am prepared to do the work if someone can tell me…

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 unit_math 13k · 22 months ago
14 votes 5 answers27k views
Is a 97.6% result from Janoshik comparable to 98.4% from Medutest?

What I have: 97.6% · Janoshik · 98.4% · Medutest. I have used one of these for a while and I am considering switching, which requires a reason. What I care about 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…

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 Dr_Lena_Ostrowska 42k · 2.1 years ago
14 votes 5 answers26k views
Is a sampling plan from QSC sufficient basis to skip independent testing?

What I have: sampling plan · QSC. 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 viable version,…

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 tobias_reint 19k · 2.1 years ago
14 votes 5 answers25k views
Is a 97.6% result from Janoshik comparable to 98.8% from Janoshik?

Numbers first: 97.6% · Janoshik · 98.8% · Janoshik. 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…

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 otto_brenner 19k · 21 months ago
14 votes5 answers23k views
Would you re-test liraglutide after ten weeks at 25 °C, or accept the original certificate?

For reference: liraglutide · ten weeks · 25 °C. I would like to define my thresholds before I have a result, for obvious reasons. I want a plan with explicit stopping…

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 samir_bennani 13k · 18 months ago
14 votes5 answers21k views
Why did two CPC lots of oral semaglutide differ on content assay?

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

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
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
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 per_haugen 18k · 15 months ago
14 votes5 answers21k views
Has anyone independently verified a WWB dulaglutide batch COA?

Numbers first: WWB · dulaglutide. I would rather be corrected now than propagate something wrong. I am specifically not interested in a testimonial; I am interested…

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 bounty_hunter_q 18k · 21 months ago
14 votes 2 answers20k views
What is the per-participant cost in a ten-person group buy once testing is included?

I have kept every message, invoice and document, which I gather is the useful habit. I can do the algebra. I am not confident about the conversion factors. If there…

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
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 marcus_thorbjorn 16k · 23 months ago
14 votes5 answers18k views
Is a 98.2% result from Medutest comparable to 96.8% from Janoshik?

What I am working with: 98.2% · Medutest · 96.8% · Janoshik. I suspect the honest answer is that it depends, in which case I would like to know on what. Assume I can…

purity
purity

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

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 fresh_bac 13k · 11 months ago
14 votes5 answers18k views
What would you ask Qingdao Sigma Chemical before a first order that they cannot fake?

I am comparing three suppliers on documentation rather than on price. I am trying to do this correctly the first time rather than learn it by getting it wrong. I have…

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 oona_kekkonen 16k · 11 months ago
14 votes 5 answers16k views
What does a date of analysis on an HJ report change about how I read it?

The particulars: date of analysis · HJ. I want to understand what this actually establishes, as opposed to what it is being used to imply. My concern is that I am…

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 second_lot 11k · 19 months ago
14 votes 2 answers16k views
Would you re-test tirzepatide after ten weeks at room temperature, or accept the original certificate?

The particulars: tirzepatide · ten weeks · room temperature. 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 juliette_farnese 12k · 14 months ago
14 votes 4 answers16k views
How do I reconcile 97.6% from Janoshik with 97.1% from the supplier?

What I have: 97.6% · Janoshik · 97.1%. I have a result I cannot explain, and I would rather diagnose it than guess. I have checked the obvious explanations and…

purity
purity

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

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 eighty_six_hours 16k · 9 months ago
14 votes 5 answers14k views
Is a 99.1% result from VendorInvestigate comparable to 98.4% from PeptideMeter?

The case in front of me: 99.1% · VendorInvestigate · 98.4% · 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…

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 leah_ferrers 15k · 15 months ago
14 votes 5 answers14k views
How do I trace a Homopeptide lot number back to a synthesis date?

The lot number on the vial matches the certificate, which at least rules out the easy problem. I have done this once and I suspect I got away with it rather than got…

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 anouk_desmet 18k · 7 months ago
14 votes 2 answers12k views
Does a large published testing history at ERP imply lot consistency?

The method section is present, which is unusual enough that I want to make use of it. The empirical answer seems settled. The explanation does not. If the honest…

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
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
asked by rosa_mendieta 13k · 8 months ago
14 votes 5 answers11k views
What does a date of analysis on a Homopeptide report change about how I read it?

The particulars: date of analysis · Homopeptide. I want to understand what this actually establishes, as opposed to what it is being used to imply. My concern is that…

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 coring_risk 17k · 22 months ago
14 votes 4 answers8.9k views
Is a lot-specific certificate from KP sufficient basis to skip independent testing?

What I am working with: lot-specific certificate · KP. I am trying to build something sustainable rather than something thorough that I will abandon. I have already…

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 ahmed_zerouali 19k · 4 months ago
14 votes0 answers7.6k views
What does a good question on this site look like?

I have certificates from two lots and an independent result on one of them. I want a method I can write down and repeat, not a rule of thumb. I would rather…

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
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 h_villanueva 50k · 21 months ago