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coa

Page 18 of 32 · 749 questions tagged coa.

749 questions · sorted by votes · page 18 of 32

17 votes 4 answers31k views
Is a method section from CPC sufficient basis to skip independent testing?

The particulars: method section · CPC. I am at the decision point and I would rather think it through than improvise. I would rather spend money on measurement than…

coa
coa

Certificates of analysis: what fields a useful one carries, how to tell a real analytical report from a marketing document, batch and lot…

749 questions
batch-testing
batch-testing

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

865 questions
harm-reduction
harm-reduction

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

445 questions
asked by vialroom 87k · 2.1 years ago
17 votes5 answers31k views
What does 96.4% purity on a C8 column actually tell me about a liraglutide vial?

Numbers first: 96.4% · a C8 column · liraglutide. I can parse the result. I am less sure what it licenses me to conclude. I have deliberately not looked at anyone…

hplc
hplc

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

466 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…

788 questions
coa
coa

Certificates of analysis: what fields a useful one carries, how to tell a real analytical report from a marketing document, batch and lot…

749 questions
asked by anouk_desmet 18k · 2.0 years ago
17 votes 5 answers24k views
Would you re-test oral semaglutide after ten weeks at minus 80 °C, or accept the original certificate?

For reference: oral semaglutide · ten weeks · minus 80 °C. I would like to define my thresholds before I have a result, for obvious reasons. I want a plan with…

batch-testing
batch-testing

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

865 questions
peptide-stability
peptide-stability

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

832 questions
coa
coa

Certificates of analysis: what fields a useful one carries, how to tell a real analytical report from a marketing document, batch and lot…

749 questions
asked by nils_karlberg 13k · 2.3 years ago
17 votes 5 answers23k views
Is a sterility test on one vial from a five-person group buy enough for the whole split?

Numbers first: a sterility test · a five-person group buy. I would rather over-plan the first cycle and simplify later. I am prepared to do the work if someone can…

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…

865 questions
coa
coa

Certificates of analysis: what fields a useful one carries, how to tell a real analytical report from a marketing document, batch and lot…

749 questions
asked by dana_wexler 15k · 20 months ago
17 votes 5 answers19k views
Would you re-test orforglipron after two weeks at 4 °C, or accept the original certificate?

Setup, so nobody has to ask: orforglipron · two weeks · 4 °C. I am trying to build something sustainable rather than something thorough that I will abandon. 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…

865 questions
peptide-stability
peptide-stability

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

832 questions
coa
coa

Certificates of analysis: what fields a useful one carries, how to tell a real analytical report from a marketing document, batch and lot…

749 questions
asked by threadlock7 14k · 9 months ago
17 votes5 answers15k views
What does 99.1% purity on a C8 column actually tell me about an oral semaglutide vial?

Numbers first: 99.1% · a C8 column · oral semaglutide. This is presented as though it settles something, and I am not convinced it does. I have two documents that…

hplc
hplc

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

466 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…

788 questions
coa
coa

Certificates of analysis: what fields a useful one carries, how to tell a real analytical report from a marketing document, batch and lot…

749 questions
asked by Dr_Otto_Lindqvist 38k · 2.2 years ago
17 votes 5 answers15k views
How do I trace a QST lot number back to a synthesis date?

The lot number on the vial matches the certificate, which at least rules out the easy problem. I have done this once and I suspect I got away with it rather than got…

batch-testing
batch-testing

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

865 questions
coa
coa

Certificates of analysis: what fields a useful one carries, how to tell a real analytical report from a marketing document, batch and lot…

749 questions
vendor-vetting
vendor-vetting

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

436 questions
asked by jo_vandeberg 19k · 12 months ago
17 votes0 answers14k views
What does 96.4% purity on a C4 column actually tell me about a dulaglutide vial?

Conditions: 96.4% · a C4 column · dulaglutide. The figures are clear enough; the question is what they mean and what they do not. I can supply the numbers if the…

hplc
hplc

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

466 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…

788 questions
coa
coa

Certificates of analysis: what fields a useful one carries, how to tell a real analytical report from a marketing document, batch and lot…

749 questions
asked by noor_alhassan 15k · 12 months ago
17 votes 3 answers12k views
What does 97.1% purity on a C8 column actually tell me about a liraglutide vial?

What I have: 97.1% · a C8 column · liraglutide. I can parse the result. I am less sure what it licenses me to conclude. I have deliberately not looked at anyone…

hplc
hplc

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

466 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…

788 questions
coa
coa

Certificates of analysis: what fields a useful one carries, how to tell a real analytical report from a marketing document, batch and lot…

749 questions
asked by u100_marks 38k · 9 months ago
17 votes 5 answers11k views
What accept/reject threshold would you set for cagrilintide before seeing the result?

This is my second independent submission on material from the same supplier. I would rather over-plan the first cycle and simplify later. I am prepared to do the work…

batch-testing
batch-testing

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

865 questions
harm-reduction
harm-reduction

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

445 questions
coa
coa

Certificates of analysis: what fields a useful one carries, how to tell a real analytical report from a marketing document, batch and lot…

749 questions
asked by zeynep_arslan 20k · 6 months ago
17 votes5 answers11k views
Does SWB issue lot-specific documentation, or a batch certificate?

This is my second independent submission on material from the same supplier. This is presented as though it settles something, and I am not convinced it does. 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…

865 questions
coa
coa

Certificates of analysis: what fields a useful one carries, how to tell a real analytical report from a marketing document, batch and lot…

749 questions
vendor-vetting
vendor-vetting

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

436 questions
asked by fiadh_cronin 14k · 9 months ago
17 votes 4 answers9.1k views
How do I check that the ESI-MS peaks on a COA actually correspond to semaglutide or tirzepatide?

I have two third-party reports in front of me. Both say "identity confirmed by ESI-MS" and both include a spectrum, but the spectra look nothing like the single clean…

mass-spec
mass-spec

Mass spectrometry for identity confirmation: electrospray ionisation, multiple charge states, monoisotopic versus average mass, deconvolution, and…

38 questions
lc-ms
lc-ms

Liquid chromatography coupled to mass spectrometry: separation and identification in one run, and the method of choice when you need to know not…

14 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…

360 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…

162 questions
coa
coa

Certificates of analysis: what fields a useful one carries, how to tell a real analytical report from a marketing document, batch and lot…

749 questions
asked by fresh_bac 13k · 17 months ago
17 votes 5 answers9k views
Would you re-test cagrilintide after six weeks at 4 °C, or accept the original certificate?

Numbers first: cagrilintide · six weeks · 4 °C. This is a planning question. I know what my options are; I do not know how to weigh them. What I want is the minimum…

batch-testing
batch-testing

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

865 questions
peptide-stability
peptide-stability

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

832 questions
coa
coa

Certificates of analysis: what fields a useful one carries, how to tell a real analytical report from a marketing document, batch and lot…

749 questions
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 carys_meredith 17k · 11 months ago
17 votes 5 answers7.8k views
Has anyone independently verified a CPC oral semaglutide batch COA?

The case in front of me: CPC · oral semaglutide. I want to know whether there is evidence behind this or only repetition. I have checked the obvious registries and…

vendor-vetting
vendor-vetting

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

436 questions
coa
coa

Certificates of analysis: what fields a useful one carries, how to tell a real analytical report from a marketing document, batch and lot…

749 questions
batch-testing
batch-testing

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

865 questions
asked by fib4_reader 35k · 3 months ago
17 votes5 answers7.6k views
What should I make of a cagrilintide certificate that has no lot-specific certificate?

What I have: cagrilintide · lot-specific certificate. 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…

749 questions
vendor-vetting
vendor-vetting

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

436 questions
batch-testing
batch-testing

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

865 questions
asked by Dr_Lena_Ostrowska 42k · 10 months ago
17 votes0 answers6.4k views
Why does compounded dulaglutide potency vary between pharmacies?

The pharmacy is accredited and I have verified that on the accreditor register. The empirical answer seems settled. The explanation does not. If the honest answer is…

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…

438 questions
coa
coa

Certificates of analysis: what fields a useful one carries, how to tell a real analytical report from a marketing document, batch and lot…

749 questions
asked by halvard_ness 42k · 5 months ago
17 votes0 answers5.6k views
What does a 98.8% purity with a lot-specific certificate attached let me conclude?

Details up front: 98.8% · lot-specific certificate. This is presented as though it settles something, and I am not convinced it does. I have two documents that appear…

purity
purity

Purity as chromatographic area per cent - the fraction of detected material that is your target peak. It says nothing about how much material is…

788 questions
coa
coa

Certificates of analysis: what fields a useful one carries, how to tell a real analytical report from a marketing document, batch and lot…

749 questions
hplc
hplc

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

466 questions
asked by Dr_Malik_Osei 37k · 3 months ago
17 votes 3 answers4.6k views
How do I read a sequence coverage map, and why is 100% coverage sometimes worthless?

I received a mapping report on tirzepatide. It states "sequence coverage: 100%" in bold at the top, and then the fragment table has exactly two entries in it.…

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…

83 questions
lc-ms
lc-ms

Liquid chromatography coupled to mass spectrometry: separation and identification in one run, and the method of choice when you need to know not…

14 questions
coa
coa

Certificates of analysis: what fields a useful one carries, how to tell a real analytical report from a marketing document, batch and lot…

749 questions
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…

162 questions
batch-testing
batch-testing

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

865 questions
asked by a_lindgren 46k · 9 months ago
17 votes 5 answers4.4k views
What does a list of related substances on an SSA report change about how I read it?

Conditions: list of related substances · SSA. The figures are clear enough; the question is what they mean and what they do not. I can supply the numbers if the…

coa
coa

Certificates of analysis: what fields a useful one carries, how to tell a real analytical report from a marketing document, batch and lot…

749 questions
batch-testing
batch-testing

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

865 questions
vendor-vetting
vendor-vetting

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

436 questions
asked by anders_vestby 17k · 4 months ago
17 votes0 answers4k views
Has anyone independently verified a BCH a GLP-1 receptor agonist batch COA?

What I am working with: BCH · a GLP-1 receptor agonist. This has the shape of a fact but I cannot find its origin. What I found instead were three secondary sources…

vendor-vetting
vendor-vetting

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

436 questions
coa
coa

Certificates of analysis: what fields a useful one carries, how to tell a real analytical report from a marketing document, batch and lot…

749 questions
batch-testing
batch-testing

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

865 questions
asked by nils_karlberg 13k · 7 months ago
17 votes 1 answer3.4k views
Would you re-test tirzepatide after three weeks at 30 °C, or accept the original certificate?

The specifics, since they change the answer: tirzepatide · three weeks · 30 °C. I am at the decision point and I would rather think it through than improvise. I would…

batch-testing
batch-testing

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

865 questions
peptide-stability
peptide-stability

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

832 questions
coa
coa

Certificates of analysis: what fields a useful one carries, how to tell a real analytical report from a marketing document, batch and lot…

749 questions
asked by claudia_ferrante 46k · 6 months ago
16 votes 5 answers24k views
What accept/reject threshold would you set for a GLP-1 receptor agonist before seeing the result?

This is my second independent submission on material from the same supplier. This is a planning question. I know what my options are; I do not know how to weigh them.…

batch-testing
batch-testing

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

865 questions
harm-reduction
harm-reduction

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

445 questions
coa
coa

Certificates of analysis: what fields a useful one carries, how to tell a real analytical report from a marketing document, batch and lot…

749 questions
asked by anja_hellstrom 13k · 18 months ago
16 votes 5 answers22k views
Has anyone independently verified a GL Biochem semaglutide batch COA?

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

vendor-vetting
vendor-vetting

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

436 questions
coa
coa

Certificates of analysis: what fields a useful one carries, how to tell a real analytical report from a marketing document, batch and lot…

749 questions
batch-testing
batch-testing

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

865 questions
asked by plunger_stop 18k · 13 months ago
16 votes 5 answers21k views
What does 98.4% purity on a C8 column actually tell me about a tirzepatide vial?

Numbers first: 98.4% · a C8 column · tirzepatide. I can parse the result. I am less sure what it licenses me to conclude. I have deliberately not looked at anyone…

hplc
hplc

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

466 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…

788 questions
coa
coa

Certificates of analysis: what fields a useful one carries, how to tell a real analytical report from a marketing document, batch and lot…

749 questions
asked by lipid_panel_q 44k · 14 months ago