PeptideStack
5.2kquestions
20kanswers
220users

batch-testing

Page 31 of 37 · 865 questions tagged batch-testing.

865 questions · sorted by votes · page 31 of 37

8 votes0 answers3.7k views
How many vials from a CPC lot should I send for an HPLC purity test?

The case in front of me: CPC · 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…

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 gradient_slope 41k · 9 months ago
8 votes0 answers3k views
How many vials from an SSA lot should I send for an endotoxin test?

For reference: SSA · 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 pascal_thibault 13k · 2 months ago
8 votes0 answers2.8k views
Does KP 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. This is presented as though it settles something, and I am not convinced it…

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 coldbox9 13k · 8 months ago
8 votes 4 answers2.7k views
Would you re-test semaglutide after twelve weeks at minus 80 °C, or accept the original certificate?

Concretely: semaglutide · twelve weeks · minus 80 °C. I want to decide this in advance so that I am not deciding it under pressure later. Assume I will follow 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
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 ravi_pillai 16k · 4 months ago
8 votes 5 answers2.3k views
How do I reconcile 98.2% from Janoshik with 97.9% from the supplier?

Numbers first: 98.2% · Janoshik · 97.9%. 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 marta_szymanska 17k · 2 months ago
8 votes0 answers1.9k views
How many vials from a BCH lot should I send for peptide mapping?

Stated plainly: BCH · peptide mapping. The units are where I keep going wrong, so please be explicit about them. I have sanity-checked the order of magnitude and it…

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 void_volume 13k · 4 months ago
7 votes5 answers20k views
How do I reconcile 97.1% from VendorInvestigate with 98.4% from the supplier?

The case in front of me: 97.1% · VendorInvestigate · 98.4%. I have two candidate explanations and no way to distinguish them. The same procedure has worked without…

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 imani_dube 19k · 16 months ago
7 votes 5 answers18k views
Is a 98.2% result from VendorInvestigate comparable to 99.4% from Janoshik?

Concretely: 98.2% · VendorInvestigate · 99.4% · 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 nine_point_nine 45k · 14 months ago
7 votes 4 answers17k views
Does TFC issue lot-specific documentation, or a batch certificate?

The lot number on the vial matches the certificate, which at least rules out the easy problem. The figures are clear enough; the question is what they mean and what…

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 meniscus_film 34k · 16 months ago
7 votes 5 answers15k views
Why did two JEEP lots of dulaglutide differ on content assay?

Numbers first: JEEP · dulaglutide. 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,…

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 kelvin_lam 11k · 10 months ago
7 votes5 answers12k views
My survodutide vial sat at 40 °C for five days — is testing worth it before use?

Conditions: survodutide · 40 °C · five days. I want to decide this in advance so that I am not deciding it under pressure later. Assume I will follow the plan I write…

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 coring_risk 17k · 14 months ago
7 votes 5 answers9.4k views
What does a method section on a CPC report change about how I read it?

The particulars: method section · CPC. 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 swab_and_wait 15k · 12 months ago
7 votes 5 answers8.9k views
Why would Janoshik report 96.8% where the supplier certificate says something higher?

Stated plainly: Janoshik · 96.8%. This is not behaving the way I expected and I want to understand the discrepancy before I act on it. I have photographed the current…

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 grainne_ahearn 13k · 17 months ago
7 votes 5 answers8.5k views
Is a 98.4% result from Janoshik comparable to 97.1% from PeptideMeter?

Numbers first: 98.4% · Janoshik · 97.1% · PeptideMeter. 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 orla_sheridan 14k · 8 months ago
7 votes5 answers6.3k views
How do Janoshik and Medutest results compare on the same batch?

This is my second independent submission on material from the same supplier. I have used one of these for a while and I am considering switching, which requires a…

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 Dr_Marek_Zielinski 39k · 11 months ago
7 votes2 answers5.6k views
Would you re-test ecnoglutide after twelve weeks at room temperature, or accept the original certificate?

Conditions: ecnoglutide · twelve weeks · room temperature. I want to decide this in advance so that I am not deciding it under pressure later. Assume I will follow…

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 per_haugen 18k · 6 months ago
7 votes 5 answers2.7k views
Why did two SGN lots of orforglipron differ on content assay?

What I have: SGN · orforglipron. 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, 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
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 greta_holzmann 15k · 3 months ago
7 votes0 answers2.6k views
What does a list of related substances on a GL Biochem report change about how I read it?

The case in front of me: list of related substances · GL Biochem. The figures are clear enough; the question is what they mean and what they do not. I can supply 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 retest_please 13k · 7 months ago
7 votes 4 answers2.5k views
Why would PeptideMeter report 95.2% where the supplier certificate says something higher?

Concretely: PeptideMeter · 95.2%. 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 kelvin_lam 11k · 5 months ago
7 votes 5 answers2.4k views
Is a 97.1% result from VendorInvestigate comparable to 95.2% from PeptideMeter?

The case in front of me: 97.1% · VendorInvestigate · 95.2% · 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 orla_sheridan 14k · 3 months ago
7 votes 5 answers2.1k views
Is peptide mapping worth paying for on top of a purity figure for semaglutide?

The specifics, since they change the answer: peptide mapping · semaglutide. I would like to define my thresholds before I have a result, for obvious reasons. I want a…

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 ines_delacruz 16k · 5 days ago
7 votes0 answers1.6k views
Is a re-test after storage a stability study or a waste of money?

The material is still sealed, so I have not committed to anything yet. This is a planning question. I know what my options are; I do not know how to weigh them. What…

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
storage
storage

Storage conditions and their evidence base: minus twenty degrees for powder, refrigerated for solution, protection from light, and what the…

646 questions
asked by Dr_Lena_Ostrowska 42k · 4 months ago
6 votes5 answers25k views
Is a 97.9% result from Janoshik comparable to 99.1% from Medutest?

Details up front: 97.9% · Janoshik · 99.1% · Medutest. I have used one of these for a while and I am considering switching, which requires a reason. What I care about…

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 tare_and_weigh 18k · 2.4 years ago
6 votes 5 answers22k views
My oral semaglutide vial sat at 40 °C for fourteen days — is testing worth it before use?

For reference: oral semaglutide · 40 °C · fourteen days. I am at the decision point and I would rather think it through than improvise. I would rather spend money on…

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 tenth_of_a_unit 40k · 19 months ago