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coa

Page 7 of 33 · 771 questions tagged coa.

771 questions · sorted by votes · page 7 of 33

29 votes 5 answers32k views
What does a chromatogram on an SSA report change about how I read it?

Setup, so nobody has to ask: 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…

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
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 sunniva_dahl 22k · 12 months ago
29 votes0 answers32k views
How does QST compare to Shanghai Wibson Biotechnology on documentation quality?

Conditions: QST · Shanghai Wibson Biotechnology. I would like the axes of comparison first and the recommendation second. I have tried the first option and it works;…

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
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 ivo_paunovic 16k · 21 months ago
29 votes2 answers31k views
How does KP compare to Shanghai ERP Biotechnology on documentation quality?

Stated plainly: KP · Shanghai ERP Biotechnology. I want to know what the trade-off actually is rather than which option is fashionable. I would rather have a…

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
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 low_dead_space 37k · 17 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…

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
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
asked by jo_vandeberg 23k · 14 months ago
29 votes 5 answers28k views
How does Homopeptide compare to Zhuhai Kerui Biotechnology on documentation quality?

Stated plainly: Homopeptide · Zhuhai Kerui Biotechnology. I would like the axes of comparison first and the recommendation second. I have tried the first option and…

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
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 area_percent 9.9k · 21 months ago
29 votes 5 answers28k views
How do I reconcile 97.6% from Janoshik with 98.8% from the supplier?

Numbers first: 97.6% · Janoshik · 98.8%. 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…

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
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 cap_the_luer 14k · 18 months ago
29 votes3 answers26k views
What would you ask Shanghai Wibson Biotechnology before a first order that they cannot fake?

I have certificates from two lots and an independent result on one of them. I can find plenty of assertions about this and almost no reasoning, which is usually a…

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 pieter_maas 14k · 10 months ago
29 votes 5 answers22k views
What should I make of a retatrutide documentation package that has no sampling plan?

Setup, so nobody has to ask: retatrutide · 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…

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
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 lucia_marchetti 19k · 19 months ago
29 votes 5 answers21k views
Has anyone independently verified a WXT a GLP-1 receptor agonist batch COA?

Setup, so nobody has to ask: WXT · a GLP-1 receptor agonist. This is asserted often enough that I assumed it was established, and then I went looking for the source.…

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 sunniva_dahl 22k · 14 months ago
29 votes 5 answers21k views
How do I trace a QSC lot number back to a synthesis date?

The lot number on the vial matches the certificate, which at least rules out the easy problem. Everything I have found on this is either a forum aside or a product…

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 pascal_thibault 11k · 12 months ago
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 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 votes 5 answers18k views
What does 95.2% purity on a C8 column actually tell me about a tirzepatide vial?

Numbers first: 95.2% · a C8 column · tirzepatide. This is presented as though it settles something, and I am not convinced it does. I have two documents that appear…

hplc
hplc

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

503 questions
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
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
tirzepatide
tirzepatide

A dual GIP and GLP-1 receptor agonist. Questions here cover the SURPASS and SURMOUNT programmes, the practical differences from a pure GLP-1…

370 questions
asked by anja_hellstrom 13k · 18 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 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
What does Janoshik verification of WuXi TIDES actually cover?

What I have: Janoshik · WuXi TIDES. I can parse the result. I am less sure what it licenses me to conclude. I have deliberately not looked at anyone else’s…

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
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
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 nine_point_nine 60k · 2.1 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 answers34k views
How does MKM compare to Hubei Jianxiang Bioscience on documentation quality?

Stated plainly: 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,…

388 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 tandem_gradient 61k · 2.1 years 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