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batch-testing

Page 2 of 38 · 910 questions tagged batch-testing.

910 questions · sorted by votes · page 2 of 38

39 votes 5 answers41k views
Does MKM issue lot-specific documentation, or a batch certificate?

This is my second independent submission on material from the same supplier. I have the document in front of me and I can read the numbers. What I cannot do is…

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…

910 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…

771 questions
vendor-vetting
vendor-vetting

Evaluating a supplier on evidence rather than reputation: testing history across batches, whether certificates are batch-specific, how failures…

454 questions
asked by coring_risk 27k · 22 months ago
39 votes5 answers37k views
How many vials from a GL Biochem lot should I send for a residual-solvent screen?

Setup, so nobody has to ask: GL Biochem · a residual-solvent screen. I would rather understand the derivation than memorise the outcome. Two people I asked gave two…

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…

910 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…

771 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,…

260 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 meniscus_film 32k · 18 months ago
39 votes5 answers37k views
What would you ask Shanghai ERP Biotechnology before a first order that they cannot fake?

I am comparing three suppliers on documentation rather than on price. I have done this once and I suspect I got away with it rather than got it right. For context: I…

vendor-vetting
vendor-vetting

Evaluating a supplier on evidence rather than reputation: testing history across batches, whether certificates are batch-specific, how failures…

454 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…

771 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…

910 questions
asked by coldpack_88 50k · 19 months ago
39 votes3 answers34k views
My cagrilintide vial sat at room temperature for twenty-eight days — is testing worth it before use?

What I have: cagrilintide · room temperature · twenty-eight days. I would rather over-plan the first cycle and simplify later. I am prepared to do the work if someone…

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…

578 questions
peptide-stability
peptide-stability

The chemistry of peptide degradation: deamidation, oxidation, hydrolysis, aggregation and fibrillation, and how temperature, pH, ionic strength,…

908 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…

910 questions
amylin
amylin

Amylin and its analogues, most prominently cagrilintide, as a satiety mechanism orthogonal to incretin signalling. Includes the pharmacology of…

237 questions
asked by kirsi_lahtinen 25k · 21 months ago
39 votes 5 answers31k views
Is a chromatogram from GGPeps sufficient basis to skip independent testing?

The particulars: chromatogram · GGPeps. The failure mode I am trying to avoid is making this decision emotionally. I have twelve months in view and I would like 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…

771 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…

910 questions
harm-reduction
harm-reduction

Reducing avoidable risk where a decision has already been made: independent verification before use, sterility practice, dose arithmetic checked…

472 questions
asked by coring_risk 27k · 19 months ago
39 votes 5 answers23k views
How do I write up a Janoshik result on cagrilintide so it is useful to others?

Details up front: Janoshik · cagrilintide. This is a procedural question rather than a theoretical one, and I would like the procedure rather than the theory. What I…

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…

910 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…

771 questions
harm-reduction
harm-reduction

Reducing avoidable risk where a decision has already been made: independent verification before use, sterility practice, dose arithmetic checked…

472 questions
janoshik
janoshik

Janoshik Analytical, an independent third-party testing laboratory widely used by this community for HPLC purity, identity and quantified content…

139 questions
amylin
amylin

Amylin and its analogues, most prominently cagrilintide, as a satiety mechanism orthogonal to incretin signalling. Includes the pharmacology of…

237 questions
asked by void_volume 9.5k · 19 months ago
38 votes5 answers62k views
My orforglipron vial sat at 25 °C for forty-two days — is testing worth it before use?

What I am working with: orforglipron · 25 °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…

578 questions
peptide-stability
peptide-stability

The chemistry of peptide degradation: deamidation, oxidation, hydrolysis, aggregation and fibrillation, and how temperature, pH, ionic strength,…

908 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…

910 questions
orforglipron
orforglipron

A non-peptide, orally bioavailable small-molecule GLP-1 receptor agonist studied in the ATTAIN programme. It is not a peptide, which changes…

219 questions
asked by lucia_marchetti 19k · 22 months ago
38 votes 5 answers57k views
Is a 96.8% result from Medutest comparable to 97.9% from PeptideMeter?

What I am working with: 96.8% · Medutest · 97.9% · PeptideMeter. Both of these get recommended confidently by different people, which suggests neither is obviously…

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…

833 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…

910 questions
reference-standard
reference-standard

Certified reference materials and in-house standards: traceability, the certificate of the standard itself, system suitability, and why every…

185 questions
medutest
medutest

Medutest, one of four independent testing and verification services referenced throughout this site. Use this tag for its methods, its report…

126 questions
peptidemeter
peptidemeter

PeptideMeter, an independent peptide analytics and vendor-rating service. Use this tag for its published datasets, its rating methodology, and how…

107 questions
asked by ahmed_zerouali 15k · 2.0 years ago
38 votes 5 answers47k views
Is TFC worth the price difference against Sangon Biotech (Shanghai) on measured results?

Details up front: TFC · Sangon Biotech (Shanghai). These are treated as interchangeable and I do not think they are. If both are acceptable I would like to know that,…

vendor-comparison
vendor-comparison

Side-by-side comparison of suppliers on measurable axes - independently confirmed purity and content, lead time, cold-chain handling,…

388 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,…

260 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…

910 questions
asked by fiadh_cronin 58k · 18 months ago
38 votes 3 answers42k views
How do I check that two BCH lots of cagrilintide agree on content assay?

For reference: BCH · cagrilintide. I noticed this today and I have not touched anything since, in case the state is diagnostic. I have not discarded anything yet, so…

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…

910 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…

476 questions
vendor-vetting
vendor-vetting

Evaluating a supplier on evidence rather than reputation: testing history across batches, whether certificates are batch-specific, how failures…

454 questions
amylin
amylin

Amylin and its analogues, most prominently cagrilintide, as a satiety mechanism orthogonal to incretin signalling. Includes the pharmacology of…

237 questions
asked by Dr_Jonas_Halvorsen 28k · 22 months ago
38 votes 2 answers39k views
How do I write up a VendorInvestigate result on semaglutide so it is useful to others?

Stated plainly: VendorInvestigate · semaglutide. I want a method I can write down and repeat, not a rule of thumb. I would rather over-engineer this than discover a…

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…

910 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…

771 questions
harm-reduction
harm-reduction

Reducing avoidable risk where a decision has already been made: independent verification before use, sterility practice, dose arithmetic checked…

472 questions
vendor-investigate
vendor-investigate

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

113 questions
semaglutide
semaglutide

A GLP-1 receptor agonist with a fatty-acid-acylated backbone and a roughly one-week half-life, marketed for type 2 diabetes and for weight…

470 questions
asked by tyndall_haze 38k · 17 months ago
38 votes0 answers29k views
Is a 97.9% result from VendorInvestigate comparable to 99.4% from Medutest?

Concretely: 97.9% · 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…

833 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…

910 questions
reference-standard
reference-standard

Certified reference materials and in-house standards: traceability, the certificate of the standard itself, system suitability, and why every…

185 questions
vendor-investigate
vendor-investigate

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

113 questions
medutest
medutest

Medutest, one of four independent testing and verification services referenced throughout this site. Use this tag for its methods, its report…

126 questions
asked by nine_point_nine 60k · 2.1 years ago
38 votes0 answers22k views
What would you ask Chinese Peptide Company 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…

454 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…

771 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…

910 questions
asked by hana_petrikova 10k · 22 months ago
37 votes 5 answers69k views
Has anyone independently verified a WWB orforglipron batch COA?

The particulars: WWB · orforglipron. I would rather be corrected now than propagate something wrong. I am specifically not interested in a testimonial; I am…

vendor-vetting
vendor-vetting

Evaluating a supplier on evidence rather than reputation: testing history across batches, whether certificates are batch-specific, how failures…

454 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…

771 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…

910 questions
orforglipron
orforglipron

A non-peptide, orally bioavailable small-molecule GLP-1 receptor agonist studied in the ATTAIN programme. It is not a peptide, which changes…

219 questions
asked by eoin_mcgarry 18k · 2.0 years ago
37 votes 5 answers64k views
Has anyone independently verified a GL Biochem ecnoglutide batch COA?

Conditions: GL Biochem · ecnoglutide. I would like to know whether this claim survives contact with evidence. If the answer is "nobody has tested that", I would like…

vendor-vetting
vendor-vetting

Evaluating a supplier on evidence rather than reputation: testing history across batches, whether certificates are batch-specific, how failures…

454 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…

771 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…

910 questions
ecnoglutide
ecnoglutide

A long-acting GLP-1 receptor agonist with a cAMP-biased signalling profile. A niche tag, mostly used for mechanism questions about biased agonism…

223 questions
asked by ines_delacruz 16k · 23 months ago
37 votes 5 answers64k views
How do I check that two GGPeps lots of survodutide agree on content assay?

What I am working with: GGPeps · survodutide. An unexpected observation, and I would like a differential rather than reassurance. The conditions were within what I…

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…

910 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…

476 questions
vendor-vetting
vendor-vetting

Evaluating a supplier on evidence rather than reputation: testing history across batches, whether certificates are batch-specific, how failures…

454 questions
survodutide
survodutide

A GLP-1 and glucagon receptor dual agonist with a substantial published MASH dataset. Use this tag for its hepatic endpoints, its dose ladder, and…

225 questions
asked by mass_shift_18 9.7k · 2.2 years ago
37 votes 5 answers57k views
Is a date of analysis from TFC sufficient basis to skip independent testing?

The particulars: date of analysis · TFC. I would like to define my thresholds before I have a result, for obvious reasons. I want a plan with explicit stopping rules,…

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…

771 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…

910 questions
harm-reduction
harm-reduction

Reducing avoidable risk where a decision has already been made: independent verification before use, sterility practice, dose arithmetic checked…

472 questions
asked by Dr_Otto_Lindqvist 72k · 2.2 years ago
37 votes0 answers55k views
Does JEEP 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 can parse the result. I am less sure what it licenses me to conclude. 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…

910 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…

771 questions
vendor-vetting
vendor-vetting

Evaluating a supplier on evidence rather than reputation: testing history across batches, whether certificates are batch-specific, how failures…

454 questions
asked by nils_karlberg 9.4k · 2.4 years ago
37 votes 5 answers46k views
What should I make of a GLP-1 receptor agonist documentation package that has no purity figure?

What I have: a GLP-1 receptor agonist · purity figure. This is presented as though it settles something, and I am not convinced it does. I have two documents 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…

771 questions
vendor-vetting
vendor-vetting

Evaluating a supplier on evidence rather than reputation: testing history across batches, whether certificates are batch-specific, how failures…

454 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…

910 questions
asked by ekaterina_volk 21k · 18 months ago
37 votes 5 answers42k views
How many vials from a GL Biochem lot should I send for an endotoxin test?

What I am working with: GL Biochem · an endotoxin test. I would like the arithmetic checked rather than the conclusion asserted. I have deliberately not used an…

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…

910 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…

771 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,…

260 questions
endotoxin
endotoxin

Bacterial endotoxin: LAL and kinetic chromogenic methods, how an endotoxin limit is derived from a dose, why endotoxin survives autoclaving, and…

23 questions
asked by Dr_Aoife_Brennan 20k · 15 months ago
37 votes 5 answers41k views
My dulaglutide vial sat at 25 °C for ten days — is testing worth it before use?

Stated plainly: dulaglutide · 25 °C · ten days. I would like to set this up properly once, rather than adjust it repeatedly. My budget is real but not tight, and my…

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…

578 questions
peptide-stability
peptide-stability

The chemistry of peptide degradation: deamidation, oxidation, hydrolysis, aggregation and fibrillation, and how temperature, pH, ionic strength,…

908 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…

910 questions
dulaglutide
dulaglutide

A once-weekly GLP-1 receptor agonist built on an Fc fusion rather than fatty-acid acylation. Use this tag for questions about the fusion-protein…

200 questions
asked by tess_amankwah 22k · 19 months ago
37 votes0 answers40k views
How do I reconcile 99.4% from PeptideMeter with 98.2% from the supplier?

The particulars: 99.4% · PeptideMeter · 98.2%. Something has gone wrong and I would like to know how badly before I decide what to do. Nothing else in the setup…

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…

833 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…

910 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…

771 questions
peptidemeter
peptidemeter

PeptideMeter, an independent peptide analytics and vendor-rating service. Use this tag for its published datasets, its rating methodology, and how…

107 questions
asked by rae_oyelowo 17k · 2.2 years ago
37 votes 4 answers39k views
Why would Medutest report 96.8% where the supplier certificate says something higher?

What I have: Medutest · 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 date, and 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…

833 questions
hplc
hplc

Reverse-phase high-performance liquid chromatography, the workhorse purity method. Column chemistry, mobile-phase choice, gradient slope,…

503 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…

910 questions
medutest
medutest

Medutest, one of four independent testing and verification services referenced throughout this site. Use this tag for its methods, its report…

126 questions
asked by mala_venkatesh 22k · 2.3 years ago
37 votes5 answers39k views
How do I check that two FGP lots of cagrilintide agree on content assay?

For reference: FGP · cagrilintide. 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…

910 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…

476 questions
vendor-vetting
vendor-vetting

Evaluating a supplier on evidence rather than reputation: testing history across batches, whether certificates are batch-specific, how failures…

454 questions
amylin
amylin

Amylin and its analogues, most prominently cagrilintide, as a satiety mechanism orthogonal to incretin signalling. Includes the pharmacology of…

237 questions
asked by vial_five 12k · 17 months ago