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coa

Page 11 of 32 · 749 questions tagged coa.

749 questions · sorted by votes · page 11 of 32

25 votes0 answers9.5k views
How do I reconcile 98.8% from PeptideMeter with 98.4% from the supplier?

The specifics, since they change the answer: 98.8% · PeptideMeter · 98.4%. An unexpected observation, and I would like a differential rather than reassurance. 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…

788 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 Dr_Nadia_Farsi 90k · 8 months ago
24 votes5 answers48k views
Is a sampling plan from BCH sufficient basis to skip independent testing?

Numbers first: sampling plan · BCH. 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 viable…

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 greta_holzmann 15k · 2.2 years ago
24 votes5 answers32k views
What does a 503A pharmacy need to prepare mazdutide lawfully?

I have been through one internal appeal already and would like to do the next one properly. This is presented as though it settles something, and I am not convinced…

pharmacy-503a
pharmacy-503a

Section 503A traditional compounding pharmacies specifically: patient-specific prescriptions, accreditation such as PCAB and ACHC, USP 797…

17 questions
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
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 meniscus_film 34k · 2.3 years ago
24 votes 3 answers27k views
How does QYB compare to Chinese Peptide Company on documentation quality?

For reference: QYB · Chinese Peptide Company. I am trying to choose between two options that are usually discussed as though only one exists. I am not optimising for…

vendor-comparison
vendor-comparison

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

351 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 cake_intact 18k · 14 months ago
24 votes 5 answers25k views
What does a 503A pharmacy need to prepare survodutide lawfully?

The pharmacy is accredited and I have verified that on the accreditor register. I would like to know the limits of what can be inferred from this. What I am trying to…

pharmacy-503a
pharmacy-503a

Section 503A traditional compounding pharmacies specifically: patient-specific prescriptions, accreditation such as PCAB and ACHC, USP 797…

17 questions
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
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 esben_lykke 15k · 12 months ago
24 votes 5 answers23k views
What does a 96.8% purity with a method section attached let me conclude?

Concretely: 96.8% · method section. The figures are clear enough; the question is what they mean and what they do not. I can supply the numbers if the specifics…

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 kirsi_lahtinen 45k · 10 months ago
24 votes 5 answers23k views
How does JEEP compare to WuXi TIDES on documentation quality?

Numbers first: JEEP · WuXi TIDES. I have used one of these for a while and I am considering switching, which requires a reason. What I care about is reproducibility,…

vendor-comparison
vendor-comparison

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

351 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 ahmed_zerouali 19k · 9 months ago
24 votes 3 answers21k views
What is the practical difference between a 503A and a 503B preparation?

I have been through one internal appeal already and would like to do the next one properly. The comparison I want does not seem to exist anywhere in a form I can…

pharmacy-503a
pharmacy-503a

Section 503A traditional compounding pharmacies specifically: patient-specific prescriptions, accreditation such as PCAB and ACHC, USP 797…

17 questions
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
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 retest_please 13k · 21 months ago
24 votes0 answers19k views
Is identity confirmation by mass spectrometry on one vial from a twenty-person split enough for the whole split?

For reference: identity confirmation by mass spectrometry · a twenty-person split. I would like to define my thresholds before I have a result, for obvious reasons. I…

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 jonas_ekstrom 18k · 20 months ago
24 votes0 answers17k views
How do I reconcile 98.4% from Janoshik with 98.2% from the supplier?

Numbers first: 98.4% · Janoshik · 98.2%. 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…

788 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 rae_oyelowo 21k · 17 months ago
24 votes 5 answers16k views
How do I write up a Janoshik result on a GLP-1 receptor agonist so it is useful to others?

What I am working with: Janoshik · a GLP-1 receptor agonist. This is a procedural question rather than a theoretical one, and I would like the procedure rather than…

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
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 second_lot 11k · 5 months ago
24 votes 4 answers16k views
How do I read an orforglipron chromatogram from Medutest beyond the headline number?

What I am working with: orforglipron · Medutest. I would like help reading this properly rather than being told what conclusion to reach. I have the full report…

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 leah_ferrers 15k · 8 months ago
24 votes5 answers15k views
Why does compounded cagrilintide potency vary between pharmacies?

Costs, fees and monitoring all included, I am trying to compare like with like. I can predict the outcome but I cannot explain it, which means I will get the next…

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 thermal_mass 16k · 7 months ago
24 votes 5 answers14k views
Would you re-test mazdutide after six weeks at room temperature, or accept the original certificate?

Details up front: mazdutide · six weeks · room temperature. 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…

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 oona_kekkonen 16k · 10 months ago
24 votes 5 answers14k views
Has anyone independently verified a TFC liraglutide batch COA?

The case in front of me: TFC · liraglutide. The claim is plausible, which is exactly why I want to check it. I am able to read a paper if someone points me at one.…

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 jonas_ekstrom 18k · 8 months ago
24 votes 5 answers11k views
What does a 98.2% purity with a date of analysis attached let me conclude?

Concretely: 98.2% · date of analysis. 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 result,…

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 leonid_marchuk 15k · 18 months ago
24 votes2 answers11k views
What does a sampling plan on an FGP report change about how I read it?

What I have: sampling plan · FGP. 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…

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 siobhan_deasy 16k · 23 months ago
24 votes 5 answers11k views
Why does compounded semaglutide potency vary between pharmacies?

I would like to understand the process rather than be told to try harder. I want to know whether this is a real physical effect or an artefact of how it is measured.…

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 threadlock7 14k · 3 months ago
24 votes3 answers8.8k views
On a COA, what is the difference between "peptide content", "net peptide" and "gross weight"?

I have a COA in front of me with all of the following on it, and I cannot work out which of these numbers is the one I care about: Appearance: white lyophilised…

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
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
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
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…

39 questions
acetate-content
acetate-content

Counter-ion content, most often acetate or trifluoroacetate, and why it matters: the counter-ion and residual water are part of the gross mass you…

87 questions
asked by Dr_Elias_Weiss 46k · 13 months ago
24 votes5 answers8.1k views
Is a lot-specific certificate from SWB sufficient basis to skip independent testing?

Setup, so nobody has to ask: lot-specific certificate · SWB. I am trying to build something sustainable rather than something thorough that I will abandon. I have…

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 orla_ferriter 47k · 8 months ago
24 votes5 answers6k views
How do I reconcile 99.1% from VendorInvestigate with 96.8% from the supplier?

The case in front of me: 99.1% · VendorInvestigate · 96.8%. 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…

788 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 ravenna_pace 13k · 5 months ago
24 votes0 answers4.5k views
What does a list of related substances on an MKM report change about how I read it?

Concretely: list of related substances · MKM. 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 felix_araya 17k · 5 months ago
23 votes 5 answers48k views
What should I make of a survodutide certificate that has no date of analysis?

The case in front of me: survodutide · date of analysis. The figures are clear enough; the question is what they mean and what they do not. I can supply the numbers…

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 mass_shift_18 14k · 2.1 years ago
23 votes5 answers43k views
How many vials from a CPC lot should I send for a sterility test?

The case in front of me: CPC · a sterility test. Please show the division. I want to check my own against yours. I would like the general form as well as the specific…

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
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,…

261 questions
asked by ines_brandt 93k · 23 months ago