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coa

Page 5 of 32 · 749 questions tagged coa.

749 questions · sorted by votes · page 5 of 32

32 votes5 answers33k views
How does MKM compare to Hunan Aslsen Technology on documentation quality?

The particulars: MKM · Hunan Aslsen Technology. I am trying to choose between two options that are usually discussed as though only one exists. I am not optimising…

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 forty_units 14k · 20 months ago
32 votes 5 answers31k views
How do I reconcile 97.6% from PeptideMeter with 98.8% from the supplier?

The specifics, since they change the answer: 97.6% · PeptideMeter · 98.8%. 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 cal_hennessy 14k · 23 months ago
32 votes 3 answers31k views
What does 96.8% purity on a C8 column actually tell me about a liraglutide vial?

Details up front: 96.8% · a C8 column · liraglutide. 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_Ingrid_Baumgartner 39k · 14 months ago
32 votes5 answers29k views
Would you re-test liraglutide after ten weeks at minus 80 °C, or accept the original certificate?

The particulars: liraglutide · 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 explicit…

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 klara_novotna 16k · 14 months ago
32 votes 4 answers22k views
How does GL Biochem compare to Hunan Aslsen Technology on documentation quality?

The particulars: GL Biochem · Hunan Aslsen Technology. The comparison I want does not seem to exist anywhere in a form I can evaluate. I have read the arguments 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 h_villanueva 50k · 10 months ago
32 votes0 answers22k views
What is the point of a content assay if I already have a purity figure?

I have both a purity figure and a content figure, which is why the discrepancy is visible. I can predict the outcome but I cannot explain it, which means I will get…

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
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 juliette_farnese 12k · 14 months ago
32 votes 3 answers16k views
Is there a defensible way to compare two chromatograms by eye?

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…

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 coldbox9 13k · 19 months ago
32 votes 2 answers14k views
How do I reconcile 98.4% from VendorInvestigate with 98.8% from the supplier?

The case in front of me: 98.4% · VendorInvestigate · 98.8%. 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 plunger_stop 18k · 15 months ago
32 votes5 answers9.8k views
Has anyone independently verified an SWB dulaglutide batch COA?

Numbers first: SWB · dulaglutide. I would rather be corrected now than propagate something wrong. I am specifically not interested in a testimonial; I am interested…

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 nominal_ten 14k · 11 months ago
31 votes4 answers60k views
What would you ask WuXi TIDES before a first order that they cannot fake?

I am comparing three suppliers on documentation rather than on price. I am trying to do this correctly the first time rather than learn it by getting it wrong. I have…

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 tabular_nums 47k · 2.3 years ago
31 votes 5 answers51k views
What does 96.8% purity on a C4 column actually tell me about a dulaglutide vial?

Concretely: 96.8% · a C4 column · dulaglutide. 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…

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 mala_venkatesh 21k · 2.2 years ago
31 votes5 answers43k views
Is a purity figure from JEEP sufficient basis to skip independent testing?

Stated plainly: purity figure · JEEP. I would like to set this up properly once, rather than adjust it repeatedly. My budget is real but not tight, and my tolerance…

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 helena_vidmar 18k · 19 months ago
31 votes0 answers40k views
How does FGP compare to Shanghai Sigma-Audley on documentation quality?

Stated plainly: FGP · Shanghai Sigma-Audley. Both of these get recommended confidently by different people, which suggests neither is obviously right. My constraints…

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 fib4_reader 35k · 23 months ago
31 votes 5 answers32k views
What does a list of related substances on a QYB report change about how I read it?

Conditions: list of related substances · QYB. 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 gel_pack_warm 13k · 12 months ago
31 votes 2 answers30k views
What does a re-test after a method change look like on paper?

The lot number on the vial matches the certificate, which at least rules out the easy problem. I would like to know the limits of what can be inferred from this. What…

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
hplc
hplc

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

466 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 swab_stopper 16k · 13 months ago
31 votes 5 answers21k views
What does a 503A pharmacy need to prepare tirzepatide lawfully?

I have been through one internal appeal already and would like to do the next one properly. I have the document in front of me and I can read the numbers. What I…

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 imani_dube 19k · 11 months ago
31 votes 3 answers18k views
How do I reconcile 98.4% from VendorInvestigate with 97.6% from the supplier?

Conditions: 98.4% · VendorInvestigate · 97.6%. I have two candidate explanations and no way to distinguish them. The same procedure has worked without incident…

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 unit_math 13k · 20 months ago
31 votes0 answers12k views
How do I trace an FGP lot number back to a synthesis date?

The lot number on the vial matches the certificate, which at least rules out the easy problem. This is a procedural question rather than a theoretical one, and I…

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 per_haugen 18k · 22 months ago
31 votes0 answers7.7k views
What would you ask Xi’an Mokemei Biotechnology before a first order that they cannot fake?

The lane and the lead time matter as much as the material for what I am doing. 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…

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
peptidemeter
peptidemeter

PeptideMeter, an independent peptide analytics and vendor-rating service. Use this tag for its published datasets, its rating methodology, and how…

14 questions
asked by t_oyelaran 41k · 11 months ago
30 votes 5 answers52k views
Has anyone independently verified a GL Biochem survodutide batch COA?

For reference: GL Biochem · survodutide. 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 seven_day_half 16k · 2.3 years ago
30 votes2 answers50k views
How many vials from a GGPeps lot should I send for a residual-solvent screen?

The particulars: GGPeps · 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…

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 oona_kekkonen 16k · 2.3 years ago
30 votes 5 answers45k views
How many vials from an SGN lot should I send for a quantified content assay?

Details up front: SGN · a quantified content assay. This should be a straightforward calculation and I keep getting two different answers. The numbers are arbitrary;…

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 noor_alhassan 15k · 23 months ago
30 votes 5 answers37k views
How do I reconcile 98.4% from Janoshik with 95.2% from the supplier?

Details up front: 98.4% · Janoshik · 95.2%. I have a result I cannot explain, and I would rather diagnose it than guess. I have checked the obvious explanations and…

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 ten_mg_vial 16k · 19 months ago
30 votes5 answers36k views
How do I read an impurity table on a semaglutide certificate against the 97.1% headline?

Conditions: semaglutide · 97.1%. I want the working, not the result — I need to be able to redo it with different numbers. I care about the precision as well as 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
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 nadia_kowalczyk 14k · 13 months ago