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coa

Page 23 of 33 · 771 questions tagged coa.

771 questions · sorted by votes · page 23 of 33

13 votes 5 answers17k views
How do I reconcile 97.9% from VendorInvestigate with 96.8% from the supplier?

Concretely: 97.9% · VendorInvestigate · 96.8%. I think I have a problem. I am not yet sure whether it is a real problem or a measurement artefact. I want to know…

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 ekaterina_volk 21k · 20 months ago
13 votes 5 answers17k views
What does a lot-specific certificate on an SGN report change about how I read it?

Conditions: lot-specific certificate · SGN. I have read the primary source rather than the summary, which has left me with more questions. I understand the headline.…

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 haze_check 9.3k · 12 months ago
13 votes 5 answers14k views
How does CPC compare to Wuhan Wansheng Biotechnology on documentation quality?

Details up front: CPC · Wuhan Wansheng Biotechnology. These are treated as interchangeable and I do not think they are. If both are acceptable I would like to know…

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 rania_haddad 13k · 20 months ago
13 votes4 answers13k views
How does FGP compare to GL Biochem (Shanghai) on documentation quality?

Details up front: FGP · GL Biochem (Shanghai). Both of these get recommended confidently by different people, which suggests neither is obviously right. My…

vendor-comparison
vendor-comparison

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

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 vial_five 12k · 14 months ago
13 votes 5 answers13k views
Why does compounded oral semaglutide potency vary between pharmacies?

I have been through one internal appeal already and would like to do the next one properly. I understand the observation; what I do not understand is the mechanism…

compounding
compounding

Compounded preparations: what a 503A and a 503B facility may legally prepare and when, base versus salt forms, beyond-use dating under USP…

61 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
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
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 anja_hellstrom 13k · 8 months ago
13 votes5 answers13k views
Would you re-test ecnoglutide after four weeks at 40 °C, or accept the original certificate?

The case in front of me: ecnoglutide · four weeks · 40 °C. The failure mode I am trying to avoid is making this decision emotionally. I have twelve months in view and…

batch-testing
batch-testing

Testing at the batch or lot level: sampling plans, how many vials from a lot need testing to say anything about the lot, and the difference…

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
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 Dr_Aoife_Brennan 20k · 6 months ago
13 votes5 answers13k views
What should I ask a supplier before ordering that they cannot fake?

I would rather spend on verification than on volume. This is a procedural question rather than a theoretical one, and I would like the procedure rather than the…

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 dermot_kiely 12k · 8 months ago
13 votes4 answers11k views
How do I reconcile an area-per-cent purity with an impurity table?

The lot number on the vial matches the certificate, which at least rules out the easy problem. The units are where I keep going wrong, so please be explicit about…

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
hplc
hplc

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

503 questions
asked by jana_horakova 10k · 6 months ago
13 votes 5 answers11k views
What does 98.4% purity on a wide-pore C18 column actually tell me about a cagrilintide vial?

The particulars: 98.4% · a wide-pore C18 column · cagrilintide. I have the document in front of me and I can read the numbers. What I cannot do is interpret them. I…

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
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_Priya_Raghunathan 49k · 16 months ago
13 votes 1 answer9.6k views
How many vials from a QYB lot should I send for a residual-solvent screen?

What I am working with: QYB · 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…

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 nominal_ten 12k · 11 months ago
13 votes 5 answers9.5k views
What does 96.8% purity on a wide-pore C18 column actually tell me about a cagrilintide vial?

The particulars: 96.8% · a wide-pore C18 column · cagrilintide. I have the document in front of me and I can read the numbers. What I cannot do is interpret them. I…

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
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 cake_collapsed 14k · 3 months ago
13 votes 3 answers9.5k views
What does a sampling plan on a QSC report change about how I read it?

The case in front of me: sampling plan · QSC. I can parse the result. I am less sure what it licenses me to conclude. I have deliberately not looked at anyone else’s…

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 lane_transit 60k · 11 months ago
13 votes 2 answers9.4k views
What does a defensible record-keeping setup look like?

I have kept every message, invoice and document, which I gather is the useful habit. I am at the decision point and I would rather think it through than improvise. I…

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
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
asked by thermal_mass 13k · 6 months ago
13 votes 5 answers7.9k views
What does a chromatogram on a GGPeps report change about how I read it?

The case in front of me: chromatogram · GGPeps. 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 rune_thoresen 16k · 5 months ago
13 votes0 answers5.6k views
Does QST issue lot-specific documentation, or a batch certificate?

I am comparing a supplier certificate against an independent result on the same lot. I would like to know the limits of what can be inferred from this. What I am…

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 fib4_reader 24k · 21 months ago
13 votes5 answers4.9k views
How does QST compare to Wuhan Wansheng Biotechnology on documentation quality?

Details up front: QST · Wuhan Wansheng Biotechnology. These are treated as interchangeable and I do not think they are. If both are acceptable I would like to know…

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 zainab_mustafa 21k · 5 months ago
13 votes5 answers4.1k views
What does a purity figure on a KP report change about how I read it?

The case in front of me: purity figure · KP. I would like help reading this properly rather than being told what conclusion to reach. I have the full report including…

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 Dr_Fatima_Belkacem 18k · 6 months ago
12 votes 5 answers30k views
Is a method section from QST sufficient basis to skip independent testing?

For reference: method section · QST. I am at the decision point and I would rather think it through than improvise. I would rather spend money on measurement than 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 gradient_slope 46k · 2.1 years ago
12 votes 5 answers28k views
Would you re-test a GLP-1 receptor agonist after six weeks at 25 °C, or accept the original certificate?

Details up front: a GLP-1 receptor agonist · six weeks · 25 °C. This is a planning question. I know what my options are; I do not know how to weigh them. What I want…

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 t_oyelaran 79k · 20 months ago
12 votes 5 answers25k views
How do I reconcile 96.4% from VendorInvestigate with 97.9% from the supplier?

Concretely: 96.4% · VendorInvestigate · 97.9%. I think I have a problem. I am not yet sure whether it is a real problem or a measurement artefact. I want to know…

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 swirl_dont_shake 10k · 16 months ago
12 votes 5 answers21k views
Would you re-test semaglutide after four weeks at 37 °C, or accept the original certificate?

Concretely: semaglutide · four weeks · 37 °C. The failure mode I am trying to avoid is making this decision emotionally. I have twelve months in view and I would like…

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
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 ruaidhri_o_shea 25k · 17 months ago
12 votes 5 answers19k views
Is a batch certificate from ERP sufficient basis to skip independent testing?

The particulars: batch certificate · ERP. 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 k_szabo 27k · 14 months ago
12 votes5 answers18k views
What does a sampling plan on an ERP report change about how I read it?

Setup, so nobody has to ask: sampling plan · ERP. I can parse the result. I am less sure what it licenses me to conclude. I have deliberately not looked at anyone…

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 coring_risk 27k · 22 months ago
12 votes 5 answers18k views
Would you re-test liraglutide after ten weeks at 4 °C, or accept the original certificate?

The specifics, since they change the answer: liraglutide · ten weeks · 4 °C. I would like to define my thresholds before I have a result, for obvious reasons. I want…

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
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 nkem_obiora 39k · 2.2 years ago