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batch-testing

Page 18 of 37 · 865 questions tagged batch-testing.

865 questions · sorted by votes · page 18 of 37

20 votes3 answers7.1k views
What does a method section on a TFC report change about how I read it?

For reference: method section · TFC. 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 lipid_panel_q 44k · 8 months ago
20 votes3 answers5.9k views
How many vials from a QYB lot should I send for an endotoxin test?

The particulars: QYB · an endotoxin test. I would like the arithmetic checked rather than the conclusion asserted. I have deliberately not used an online calculator…

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 lyoph_cake 95k · 2 months ago
20 votes 4 answers5.5k views
C18 or C8, and TFA or formic acid or phosphate — how much does each choice move the purity figure?

I am trying to specify a method to a contract lab rather than accept their default, and I do not know enough to write a sensible specification. The choices I can see…

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
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
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
tirzepatide
tirzepatide

A dual GIP and GLP-1 receptor agonist. Questions here cover the SURPASS and SURMOUNT programmes, the practical differences from a pure GLP-1…

162 questions
asked by elke_brunner 14k · 2 months ago
20 votes0 answers5k views
My orforglipron vial sat at room temperature for forty-two days — is testing worth it before use?

Stated plainly: orforglipron · room temperature · forty-two days. I am trying to build something sustainable rather than something thorough that I will abandon. I…

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 bridget_nyathi 16k · 12 months ago
20 votes 5 answers4.6k views
Is a residual-solvent screen on one vial from a ten-person group buy enough for the whole split?

What I am working with: a residual-solvent screen · a ten-person group buy. I would like to set this up properly once, rather than adjust it repeatedly. My budget is…

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 gel_pack_warm 13k · 5 months ago
20 votes 1 answer4.6k views
How many vials from a WWB lot should I send for a Karl Fischer water content test?

Details up front: WWB · a Karl Fischer water content test. I can do the algebra. I am not confident about the conversion factors. If there is a standard way to lay…

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 noor_alhassan 15k · 6 months ago
20 votes5 answers3.8k views
Why would PeptideMeter report 99.1% where the supplier certificate says something higher?

Concretely: PeptideMeter · 99.1%. 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…

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 dana_wexler 15k · 40 days ago
20 votes 5 answers3.3k views
Is a 98.4% result from VendorInvestigate comparable to 97.6% from PeptideMeter?

The case in front of me: 98.4% · VendorInvestigate · 97.6% · 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 helena_vidmar 18k · 3 months ago
20 votes 2 answers2.8k views
Why did two FGP lots of a GLP-1 receptor agonist differ on content assay?

Stated plainly: FGP · a GLP-1 receptor agonist. This is not behaving the way I expected and I want to understand the discrepancy before I act on it. I have…

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 swirl_dont_shake 19k · 22 days ago
19 votes5 answers48k views
Is a sterility test worth paying for on top of a purity figure for retatrutide?

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…

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 hana_petrikova 19k · 2.2 years ago
19 votes5 answers46k views
Does a large published testing history at SWB imply lot consistency?

This is my second independent submission on material from the same supplier. I suspect the usual explanation for this is wrong, or at least incomplete. I am aware…

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 Dr_Ravi_Selvarajah 42k · 2.1 years ago
19 votes 5 answers33k views
Does a large published testing history at WWB imply lot consistency?

This is my second independent submission on material from the same supplier. I suspect the usual explanation for this is wrong, or at least incomplete. I am aware…

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 bridget_nyathi 16k · 19 months ago
19 votes 2 answers32k views
How many vials from an MKM lot should I send for a residual-solvent screen?

The particulars: MKM · a residual-solvent screen. I would rather understand the derivation than memorise the outcome. Two people I asked gave two answers that differ…

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 eoin_mcgarry 16k · 2.0 years ago
19 votes5 answers27k views
What does a date of analysis on a TFC report change about how I read it?

The specifics, since they change the answer: date of analysis · TFC. I want to understand what this actually establishes, as opposed to what it is being used to…

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 orla_sheridan 14k · 21 months ago
19 votes 5 answers26k views
How should I budget for an endotoxin test across a twelve-month mazdutide course?

Stated plainly: an endotoxin test · mazdutide. I would like to set this up properly once, rather than adjust it repeatedly. My budget is real but not tight, and 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…

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 area_percent 13k · 13 months ago
19 votes 5 answers25k views
What is a system suitability failure and what happens to the batch?

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…

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
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 forty_units 14k · 16 months ago
19 votes 5 answers23k views
Why would VendorInvestigate report 96.8% where the supplier certificate says something higher?

For reference: VendorInvestigate · 96.8%. 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 e_dziedzic 87k · 14 months ago
19 votes0 answers21k views
Is SWB worth the price difference against Bachem Holding (Suzhou) on measured results?

Numbers first: SWB · Bachem Holding (Suzhou). I want to know what the trade-off actually is rather than which option is fashionable. I would rather have a defensible…

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 otto_brenner 19k · 21 months ago
19 votes 5 answers19k views
How do I reconcile 96.8% from Medutest with 97.6% from the supplier?

Stated plainly: 96.8% · Medutest · 97.6%. 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
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 jo_vandeberg 19k · 14 months ago
19 votes 5 answers19k views
Is a 98.2% result from VendorInvestigate comparable to 99.4% from Medutest?

Concretely: 98.2% · VendorInvestigate · 99.4% · Medutest. 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 lipid_panel_q 44k · 13 months ago
19 votes 4 answers17k views
What should I make of a tirzepatide certificate that has no list of related substances?

The particulars: tirzepatide · list of related substances. I want to understand what this actually establishes, as opposed to what it is being used to imply. My…

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
asked by k_szabo 45k · 9 months ago
19 votes5 answers16k views
Is QSC worth the price difference against Shanghai Sigma-Audley on measured results?

Stated plainly: 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,…

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 esben_lykke 15k · 18 months ago
19 votes 5 answers16k views
What should I make of a GLP-1 receptor agonist certificate that has no lot-specific certificate?

What I have: a GLP-1 receptor agonist · lot-specific certificate. I can parse the result. I am less sure what it licenses me to conclude. I have deliberately not…

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
asked by nine_point_nine 45k · 22 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…

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 colm_dunphy 16k · 21 months ago