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batch-testing

Page 7 of 37 · 865 questions tagged batch-testing.

865 questions · sorted by votes · page 7 of 37

30 votes2 answers50k views
How many vials from a GGPeps lot should I send for a residual-solvent screen?

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

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 oona_kekkonen 16k · 2.3 years ago
30 votes 5 answers45k views
How many vials from an SGN lot should I send for a quantified content assay?

Details up front: SGN · a quantified content assay. This should be a straightforward calculation and I keep getting two different answers. The numbers are arbitrary;…

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 · 23 months ago
30 votes5 answers44k views
Is a 98.8% result from PeptideMeter comparable to 98.4% from Janoshik?

The specifics, since they change the answer: 98.8% · PeptideMeter · 98.4% · Janoshik. I am trying to choose between two options that are usually discussed as though…

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 swab_stopper 16k · 2.3 years ago
30 votes5 answers43k views
Is MKM worth the price difference against Hubei Jianxiang Bioscience on measured results?

The particulars: MKM · Hubei Jianxiang Bioscience. The comparison I want does not seem to exist anywhere in a form I can evaluate. I have read the arguments for each…

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 assay_blank 39k · 2.0 years ago
30 votes 5 answers37k views
How do I reconcile 98.4% from Janoshik with 95.2% from the supplier?

Details up front: 98.4% · Janoshik · 95.2%. 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 ten_mg_vial 16k · 19 months ago
30 votes 5 answers35k views
How do I reconcile 96.8% from Medutest with 98.8% from the supplier?

Setup, so nobody has to ask: 96.8% · Medutest · 98.8%. This is not behaving the way I expected and I want to understand the discrepancy before I act on it. I have…

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_Tomas_Kral 37k · 12 months ago
30 votes5 answers33k views
How should I budget for a sterility test across a twelve-month dulaglutide course?

Numbers first: a sterility test · dulaglutide. 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…

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 nominal_ten 14k · 22 months ago
30 votes 4 answers32k views
What would you ask GL Biochem (Shanghai) before a first order that they cannot fake?

The lane and the lead time matter as much as the material for what I am doing. I want a method I can write down and repeat, not a rule of thumb. I would rather…

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 kirsi_lahtinen 45k · 2.2 years ago
30 votes0 answers31k views
Is a 98.2% result from Janoshik comparable to 96.8% from Medutest?

What I have: 98.2% · Janoshik · 96.8% · 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_Ravi_Selvarajah 42k · 2.0 years ago
30 votes 2 answers30k views
Why did two BCH lots of mazdutide differ on content assay?

What I am working with: BCH · mazdutide. This is not behaving the way I expected and I want to understand the discrepancy before I act on it. I have photographed 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
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 colm_dunphy 16k · 14 months ago
30 votes5 answers24k views
How do I reconcile 97.6% from PeptideMeter with 95.2% from the supplier?

For reference: 97.6% · PeptideMeter · 95.2%. 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
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 mira_sundqvist 19k · 23 months ago
30 votes 5 answers19k views
How do I reconcile 99.1% from Medutest with 96.4% from the supplier?

Stated plainly: 99.1% · Medutest · 96.4%. This is not behaving the way I expected and I want to understand the discrepancy before I act on it. I have photographed 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 pip_okonjo 11k · 15 months ago
30 votes 5 answers18k views
Is a 97.1% result from PeptideMeter comparable to 99.4% from Medutest?

The particulars: 97.1% · PeptideMeter · 99.4% · Medutest. I am trying to choose between two options that are usually discussed as though only one exists. I am not…

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 charge_state_3 39k · 14 months ago
30 votes5 answers16k views
Why did two KP lots of orforglipron differ on content assay?

Numbers first: KP · orforglipron. I have a result I cannot explain, and I would rather diagnose it than guess. I have checked the obvious explanations and eliminated…

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 fib4_reader 35k · 15 months ago
30 votes0 answers14k views
Has anyone independently verified a QYB ecnoglutide batch COA?

The specifics, since they change the answer: QYB · ecnoglutide. I would like to know whether this claim survives contact with evidence. If the answer is "nobody has…

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 kofi_mensah 12k · 19 months ago
30 votes5 answers11k views
What should I make of an ecnoglutide certificate that has no method section?

The case in front of me: ecnoglutide · method section. I would like to know the limits of what can be inferred from this. What I am trying to avoid is over-reading a…

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 petra_hovland 42k · 11 months ago
30 votes 5 answers11k views
What has VendorInvestigate published on MKM lots in the last year?

The case in front of me: VendorInvestigate · MKM. The figures are clear enough; the question is what they mean and what they do not. I can supply the numbers if the…

vendor-investigate
vendor-investigate

VendorInvestigate, an independent vendor review and verification service. Use this tag for questions about its verification criteria, what a…

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
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
asked by teodora_ilic 15k · 11 months ago
29 votes 5 answers58k views
How do I reconcile 99.4% from VendorInvestigate with 98.4% from the supplier?

Conditions: 99.4% · VendorInvestigate · 98.4%. 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
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 two_two_micron 15k · 2.0 years ago
29 votes 5 answers46k views
How do I reconcile 99.4% from Medutest with 96.4% from the supplier?

Stated plainly: 99.4% · Medutest · 96.4%. 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
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 zainab_mustafa 16k · 19 months ago
29 votes 5 answers46k views
My orforglipron vial sat at 40 °C for ten days — is testing worth it before use?

Setup, so nobody has to ask: orforglipron · 40 °C · ten days. I would like to set this up properly once, rather than adjust it repeatedly. My budget is real but not…

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 two_two_micron 15k · 2.3 years ago
29 votes4 answers41k views
What should I make of an ecnoglutide certificate that has no date of analysis?

Concretely: ecnoglutide · date of analysis. The figures are clear enough; the question is what they mean and what they do not. I can supply the numbers if 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
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 grainne_ahearn 13k · 21 months ago
29 votes 4 answers33k views
What would you ask Hunan Aslsen Technology before a first order that they cannot fake?

I am comparing three suppliers on documentation rather than on price. Everything I have found on this is either a forum aside or a product page, neither of which 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
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 n_takahashi 36k · 2.2 years ago
29 votes 5 answers32k views
What does a chromatogram on an SSA report change about how I read it?

The case in front of me: chromatogram · SSA. I would like to know the limits of what can be inferred from this. What I am trying to avoid is over-reading a single…

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 sunniva_dahl 11k · 12 months ago
29 votes5 answers31k views
How do I reconcile 99.1% from VendorInvestigate with 98.4% from the supplier?

The case in front of me: 99.1% · 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 jo_vandeberg 19k · 14 months ago