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batch-testing

Page 17 of 37 · 865 questions tagged batch-testing.

865 questions · sorted by votes · page 17 of 37

20 votes 4 answers31k views
How do I trace a CPC lot number back to a synthesis date?

The method section is present, which is unusual enough that I want to make use of it. I am trying to do this correctly the first time rather than learn it by getting…

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 priya_menon 11k · 23 months ago
20 votes 5 answers28k views
What accept/reject threshold would you set for ecnoglutide before seeing the result?

The method section is present, which is unusual enough that I want to make use of it. I want to decide this in advance so that I am not deciding it under pressure…

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
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 anders_vestby 17k · 19 months ago
20 votes5 answers24k views
How do I trace an HJ lot number back to a synthesis date?

The method section is present, which is unusual enough that I want to make use of it. I have done this once and I suspect I got away with it rather than got it right.…

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 greta_holzmann 15k · 21 months ago
20 votes0 answers23k views
Why would Janoshik report 99.4% where the supplier certificate says something higher?

What I am working with: Janoshik · 99.4%. 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 esben_lykke 15k · 20 months ago
20 votes 3 answers19k views
Is a batch certificate from QSC sufficient basis to skip independent testing?

Numbers first: batch certificate · QSC. I would rather over-plan the first cycle and simplify later. I am prepared to do the work if someone can tell me which work…

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 deamidation_watch 43k · 17 months ago
20 votes 5 answers19k views
Has anyone independently verified a QST liraglutide batch COA?

Conditions: QST · liraglutide. I want to know whether there is evidence behind this or only repetition. I have checked the obvious registries and monographs without…

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 ekaterina_volk 16k · 15 months ago
20 votes 5 answers17k views
Would you re-test retatrutide after eight weeks at 4 °C, or accept the original certificate?

Setup, so nobody has to ask: retatrutide · eight weeks · 4 °C. 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
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 fiadh_cronin 14k · 2.1 years ago
20 votes 5 answers17k views
Does SSA issue lot-specific documentation, or a batch certificate?

I have the report as a PDF with the chromatogram on page two, so I can quote specifics. I have the document in front of me and I can read the numbers. What I cannot…

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 orla_sheridan 14k · 13 months ago
20 votes5 answers16k views
Has anyone independently verified a BCH cagrilintide batch COA?

Stated plainly: BCH · cagrilintide. This is asserted often enough that I assumed it was established, and then I went looking for the source. I have searched the…

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 colm_dunphy 16k · 2.3 years ago
20 votes5 answers15k views
Is SGN worth the price difference against Qingdao Sigma Chemical on measured results?

Numbers first: SGN · Qingdao Sigma Chemical. I have used one of these for a while and I am considering switching, which requires a reason. What I care about is…

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 jonas_ekstrom 18k · 6 months ago
20 votes 3 answers14k views
What should a certificate of analysis contain to be worth reading?

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…

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
residual-solvent
residual-solvent

Solvents left behind by synthesis and purification - acetonitrile, TFA, DMF, DCM - their ICH limits, how they are measured by headspace GC, and…

14 questions
asked by linnea_wahlberg 14k · 23 months ago
20 votes0 answers13k views
Why would Janoshik report 98.8% where the supplier certificate says something higher?

What I am working with: Janoshik · 98.8%. 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 ben_akintola 14k · 2.3 years ago
20 votes 4 answers12k views
My tirzepatide vial sat at 4 °C for fourteen days — is testing worth it before use?

For reference: tirzepatide · 4 °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 n_takahashi 36k · 8 months ago
20 votes 5 answers10k views
My cagrilintide vial sat at 37 °C for seven days — is testing worth it before use?

What I have: cagrilintide · 37 °C · seven days. 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…

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 tare_weight 47k · 4 months ago
20 votes 5 answers9.9k views
How do I reconcile 95.2% from Janoshik with 99.4% from the supplier?

What I have: 95.2% · Janoshik · 99.4%. 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 cake_intact 18k · 16 months ago
20 votes 2 answers9.8k views
Is ERP worth the price difference against ChinaPeptides (QYAOBIO) on measured results?

Stated plainly: ERP · ChinaPeptides (QYAOBIO). 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 u100_marks 38k · 4 months ago
20 votes 3 answers9.5k views
Would you re-test semaglutide after four weeks at 4 °C, or accept the original certificate?

The case in front of me: semaglutide · 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 haze_check 17k · 20 months ago
20 votes 5 answers9.3k views
What would change my mind about a vendor I currently trust?

The lane and the lead time matter as much as the material for what I am doing. I would like to define my thresholds before I have a result, for obvious reasons. I…

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
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 pk_curve 12k · 8 months ago
20 votes 3 answers9k views
Is SSA worth the price difference against Tianjin Finder Chemical on measured results?

For reference: SSA · Tianjin Finder Chemical. The comparison I want does not seem to exist anywhere in a form I can evaluate. I have read the arguments for each and…

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 ekaterina_volk 16k · 16 months ago
20 votes 2 answers8.4k views
Does a large published testing history at GGPeps imply lot consistency?

This is my second independent submission on material from the same supplier. I understand the observation; what I do not understand is the mechanism behind 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
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 bounty_hunter_q 18k · 2 months ago
20 votes 5 answers8.4k views
What should I make of an orforglipron certificate that has no sampling plan?

Setup, so nobody has to ask: orforglipron · sampling plan. 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
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 threadlock7 14k · 4 months ago
20 votes 5 answers8.1k views
How do I reconcile 97.1% from Janoshik with 98.4% from the supplier?

What I have: 97.1% · Janoshik · 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…

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 second_lot 11k · 4 months ago
20 votes0 answers7.6k views
My orforglipron vial sat at 2–8 °C for forty-two days — is testing worth it before use?

What I am working with: orforglipron · 2–8 °C · forty-two days. I am trying to build something sustainable rather than something thorough that I will abandon. I have…

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 u100_marks 38k · 9 months ago
20 votes 5 answers7.2k views
Would you re-test a GLP-1 receptor agonist after sixteen weeks at minus 20 °C, or accept the original certificate?

What I have: a GLP-1 receptor agonist · sixteen weeks · minus 20 °C. I would rather over-plan the first cycle and simplify later. I am prepared to do the work if…

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 t_oyelaran 41k · 2 months ago