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batch-testing

Page 9 of 38 · 910 questions tagged batch-testing.

910 questions · sorted by votes · page 9 of 38

29 votes5 answers20k views
Is a batch certificate from BCH sufficient basis to skip independent testing?

Concretely: batch certificate · BCH. 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…

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 otto_brenner 12k · 8 months ago
29 votes0 answers18k views
Does a large published testing history at MKM imply lot consistency?

I have both a purity figure and a content figure, which is why the discrepancy is visible. I would like the mechanism, because I want to be able to reason 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…

910 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
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
asked by loss_on_drying 40k · 9 months ago
29 votes 3 answers18k views
How do I reconcile 97.1% from Medutest with 96.8% from the supplier?

Setup, so nobody has to ask: 97.1% · Medutest · 96.8%. I noticed this today and I have not touched anything since, in case the state is diagnostic. I have 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…

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
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 anja_hellstrom 13k · 20 months ago
29 votes0 answers17k views
Is a chromatogram from QYB sufficient basis to skip independent testing?

Stated plainly: chromatogram · QYB. The failure mode I am trying to avoid is making this decision emotionally. I have twelve months in view and I would like the plan…

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_Ravi_Selvarajah 35k · 15 months ago
29 votes 5 answers14k views
What should I make of a semaglutide documentation package that has no method section?

Setup, so nobody has to ask: semaglutide · method section. I would like to know the limits of what can be inferred from this. What I am trying to avoid is…

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
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 retest_please 9.7k · 12 months ago
29 votes 5 answers12k views
How do I check that two SWB lots of dulaglutide agree on content assay?

For reference: SWB · dulaglutide. 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…

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
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 thabo_maseko 28k · 15 months ago
29 votes 3 answers11k views
Bioburden, sterility and endotoxin are three different tests — what does each one actually prove?

A COA I was sent lists "Sterility: Sterile filtered (0.22 um)" and nothing else microbiological. Another lists "Bioburden: less than 10 CFU/g — Pass". A third lists…

sterility
sterility

Sterility as a test result rather than an adjective. Covers what a sterility test actually measures, why "sterile filtered" on a document is close…

142 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
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 orla_sheridan 18k · 23 months ago
28 votes5 answers53k views
How many vials from an SWB lot should I send for a Karl Fischer water content test?

Details up front: SWB · 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…

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
water-content
water-content

Residual moisture in a lyophilised solid, measured by Karl Fischer titration or loss on drying. It drives both the mass balance on a content assay…

51 questions
asked by wren_calloway 23k · 2.1 years ago
28 votes5 answers48k views
Has anyone independently verified an MKM survodutide batch COA?

For reference: MKM · survodutide. Somebody stated this to me confidently and I would like to check it before repeating it. I would accept a well-reasoned negative…

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
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 rae_oyelowo 17k · 2.1 years ago
28 votes5 answers48k views
Would you re-test cagrilintide after sixteen weeks at minus 20 °C, or accept the original certificate?

Numbers first: cagrilintide · sixteen weeks · minus 20 °C. I would rather over-plan the first cycle and simplify later. I am prepared to do the work if someone can…

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
peptide-stability
peptide-stability

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

908 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
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 marta_szymanska 10k · 2.3 years ago
28 votes 5 answers44k views
Is peptide mapping on one vial from a twenty-person split enough for the whole split?

Conditions: peptide mapping · a twenty-person split. I am at the decision point and I would rather think it through than improvise. I would rather spend money on…

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…

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
peptide-mapping
peptide-mapping

Enzymatic digestion followed by LC-MS/MS to confirm sequence rather than just mass. The method that catches a scrambled sequence or a D-amino-acid…

103 questions
asked by rae_oyelowo 17k · 2.2 years ago
28 votes 5 answers42k views
Has anyone independently verified a KP retatrutide batch COA?

What I am working with: KP · retatrutide. 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
retatrutide
retatrutide

An investigational GLP-1, GIP and glucagon receptor tri-agonist, studied in the TRIUMPH programme. Not approved anywhere. Use this tag for…

251 questions
asked by rune_thoresen 16k · 20 months ago
28 votes 5 answers33k views
How many vials from an SSA lot should I send for a residual-solvent screen?

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

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 j_wierzbicki 69k · 12 months ago
28 votes5 answers28k views
Would you re-test mazdutide after sixteen weeks at 37 °C, or accept the original certificate?

Numbers first: mazdutide · sixteen weeks · 37 °C. I would rather over-plan the first cycle and simplify later. I am prepared to do the work if someone can tell me…

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
peptide-stability
peptide-stability

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

908 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
mazdutide
mazdutide

A GLP-1 and glucagon receptor dual agonist developed primarily in China, with a distinct dose range and a fast-moving publication record.…

237 questions
asked by harriet_lonsdale 35k · 22 months ago
28 votes 4 answers26k views
What would you ask Shanghai Sigma-Audley before a first order that they cannot fake?

I have certificates from two lots and an independent result on one of them. 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…

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 leah_ferrers 12k · 11 months ago
28 votes 5 answers22k views
How do I check that two QST lots of oral semaglutide agree on content assay?

For reference: QST · oral semaglutide. I have two candidate explanations and no way to distinguish them. The same procedure has worked without incident several times…

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
oral-glp1
oral-glp1

Oral routes for GLP-1 receptor agonism: peptide formulations rescued by absorption enhancers such as SNAC, and true small molecules that need no…

219 questions
asked by aine_mulcahy 28k · 15 months ago
28 votes 5 answers21k views
Is a 97.1% result from PeptideMeter comparable to 95.2% from Janoshik?

The specifics, since they change the answer: 97.1% · PeptideMeter · 95.2% · 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…

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
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
janoshik
janoshik

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

139 questions
asked by nkem_obiora 39k · 7 months ago
28 votes5 answers20k views
Does PeptideMeter test the vial or accept the vendor’s sample?

This is my second independent submission on material from the same supplier. Somebody stated this to me confidently and I would like to check it before repeating 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…

910 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
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 haze_check 9.3k · 10 months ago
28 votes5 answers20k views
My liraglutide vial sat at 4 °C for three days — is testing worth it before use?

The particulars: liraglutide · 4 °C · three days. I would like to define my thresholds before I have a result, for obvious reasons. I want a plan with explicit…

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
liraglutide
liraglutide

A once-daily GLP-1 receptor agonist and the compound that established the class. Still relevant for its shorter half-life, its paediatric and…

235 questions
asked by Dr_Fatima_Belkacem 18k · 11 months ago
28 votes 5 answers20k views
Why does a certificate for the standard itself matter?

I am comparing a supplier certificate against an independent result on the same lot. This is one of those things that everyone repeats and nobody derives. This…

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
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 lipid_panel_q 36k · 19 months ago
28 votes 5 answers19k views
Is a method section from TFC sufficient basis to skip independent testing?

Setup, so nobody has to ask: method section · TFC. I am at the decision point and I would rather think it through than improvise. I would rather spend money on…

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_Aoife_Brennan 20k · 22 months ago
28 votes5 answers19k views
How do I trace a JEEP lot number back to a synthesis date?

This is my second independent submission on material from the same supplier. I can find plenty of assertions about this and almost no reasoning, which is usually 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
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 elke_brunner 17k · 2.4 years ago
28 votes3 answers19k views
Is GL Biochem worth the price difference against Hubei Jianxiang Bioscience on measured results?

Details up front: GL Biochem · Hubei Jianxiang Bioscience. I am trying to choose between two options that are usually discussed as though only one exists. I am not…

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 one_ml_bac 18k · 21 months ago
28 votes 5 answers17k views
Would you re-test a GLP-1 receptor agonist after six weeks at 30 °C, or accept the original certificate?

What I have: a GLP-1 receptor agonist · six weeks · 30 °C. This is a planning question. I know what my options are; I do not know how to weigh them. What I want 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
peptide-stability
peptide-stability

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

908 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
asked by cap_the_luer 14k · 2.0 years ago