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coa

Page 31 of 33 · 771 questions tagged coa.

771 questions · sorted by votes · page 31 of 33

4 votes 2 answers5.2k views
Is a sampling plan from FGP sufficient basis to skip independent testing?

What I am working with: sampling plan · FGP. 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…

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_Sara_Kuusela 28k · 6 months ago
4 votes5 answers4.9k views
Is a method section from Homopeptide sufficient basis to skip independent testing?

What I am working with: method section · Homopeptide. I am at the decision point and I would rather think it through than improvise. I would rather spend money 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 day_seven_trough 6.7k · 6 months ago
4 votes 5 answers4.8k views
Is a list of related substances from GGPeps sufficient basis to skip independent testing?

Concretely: list of related substances · GGPeps. I want to decide this in advance so that I am not deciding it under pressure later. Assume I will follow the plan I…

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 h_pergande 71k · 32 days ago
4 votes5 answers4.7k views
Would you re-test semaglutide after four weeks at 25 °C, or accept the original certificate?

The case in front of me: semaglutide · four weeks · 25 °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
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 rania_haddad 13k · 20 days ago
4 votes 2 answers4.6k views
What does a 95.2% purity with a chromatogram attached let me conclude?

The specifics, since they change the answer: 95.2% · chromatogram. I want to understand what this actually establishes, as opposed to what it is being used to imply.…

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 ines_delacruz 16k · 2.1 years ago
4 votes3 answers4.6k views
What would you ask Sangon Biotech (Shanghai) before a first order that they cannot fake?

I have kept every message, invoice and document, which I gather is the useful habit. I would like to understand the steps well enough to explain them to someone else.…

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 dead_volume 56k · 21 months ago
4 votes 5 answers3.9k views
How many vials from an SGN lot should I send for a Karl Fischer water content test?

Stated plainly: SGN · 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 this…

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 jonas_ekstrom 12k · 5 months ago
4 votes5 answers3.7k views
What does PeptideMeter verification of Hunan Aslsen Technology actually cover?

The case in front of me: PeptideMeter · Hunan Aslsen Technology. I have the document in front of me and I can read the numbers. What I cannot do is interpret them. I…

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
peptidemeter
peptidemeter

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

107 questions
asked by Dr_Otto_Lindqvist 72k · 3 months ago
4 votes 5 answers3.3k views
What accept/reject threshold would you set for oral semaglutide before seeing the result?

I have both a purity figure and a content figure, which is why the discrepancy is visible. I would like to define my thresholds before I have a result, for obvious…

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
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 charge_state_3 16k · 37 days ago
4 votes 5 answers3.1k views
Which red flags on a certificate are actually diagnostic?

This is a first order from this supplier, so I have no track record to reason from. I have read the primary source rather than the summary, which has left me with…

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 cold_lane 10k · 18 days ago
4 votes0 answers2.6k views
How does HJ compare to Wuhan Wansheng Biotechnology on documentation quality?

Details up front: HJ · Wuhan Wansheng Biotechnology. I would like the axes of comparison first and the recommendation second. I have tried the first option and it…

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 leah_ferrers 12k · 7 months ago
4 votes 3 answers2.4k views
What does a 97.1% purity with a date of analysis attached let me conclude?

Conditions: 97.1% · 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…

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 tadhg_o_riordan 7.7k · 9 months ago
4 votes5 answers1.6k views
Has anyone independently verified an HJ liraglutide batch COA?

Details up front: HJ · liraglutide. I want to know whether there is evidence behind this or only repetition. I have checked the obvious registries and monographs…

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
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 shear_at_the_front 17k · 2 months ago
4 votes0 answers1.3k views
What does a 503A pharmacy need to prepare cagrilintide lawfully?

I have the plan documents and the written criteria, which took two calls to obtain. This is presented as though it settles something, and I am not convinced it does.…

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…

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 fill_volume 22k · 6 months ago
4 votes0 answers1.3k views
What should I make of a retatrutide documentation package that has no batch certificate?

Setup, so nobody has to ask: retatrutide · batch certificate. I would like help reading this properly rather than being told what conclusion to reach. I have the full…

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 w_okoye 43k · 10 months ago
3 votes 5 answers18k views
Has anyone independently verified a GGPeps ecnoglutide batch COA?

The specifics, since they change the answer: GGPeps · ecnoglutide. I would like to know whether this claim survives contact with evidence. If the answer is "nobody…

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
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 liam_bracken 6.9k · 17 months ago
3 votes5 answers17k views
What does a 99.1% purity with a lot-specific certificate attached let me conclude?

Numbers first: 99.1% · lot-specific certificate. This is presented as though it settles something, and I am not convinced it does. I have two documents that appear to…

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 thermal_mass 13k · 17 months ago
3 votes 5 answers12k views
How do I reconcile 98.2% from Janoshik with 96.8% from the supplier?

What I have: 98.2% · Janoshik · 96.8%. 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…

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 teodora_ilic 17k · 14 months ago
3 votes 5 answers7.9k views
Would you re-test mazdutide after sixteen weeks at 4 °C, or accept the original certificate?

What I have: mazdutide · sixteen weeks · 4 °C. I would rather over-plan the first cycle and simplify later. I am prepared to do the work if someone can tell me which…

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
mazdutide
mazdutide

A GLP-1 and glucagon receptor dual agonist developed primarily in China, with a distinct dose range and a fast-moving publication record.…

237 questions
asked by carys_meredith 12k · 10 months ago
3 votes 5 answers7.2k views
What does 96.8% purity on a C18 column actually tell me about a semaglutide vial?

Setup, so nobody has to ask: 96.8% · a C18 column · semaglutide. I would like help reading this properly rather than being told what conclusion to reach. I have the…

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
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 nominal_ten 12k · 5 months ago
3 votes 5 answers6.4k views
What does a sampling plan on a BCH report change about how I read it?

Conditions: sampling plan · BCH. 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 amara_nwachukwu 20k · 10 months ago
3 votes 5 answers6.4k views
How many vials from an FGP lot should I send for peptide mapping?

Stated plainly: FGP · peptide mapping. The units are where I keep going wrong, so please be explicit about them. I have sanity-checked the order of magnitude and it…

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
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 drawn_and_capped 12k · 5 months ago
3 votes 5 answers6k views
What should I make of a tirzepatide documentation package that has no chromatogram?

Conditions: tirzepatide · chromatogram. I have the document in front of me and I can read the numbers. What I cannot do is interpret them. I am reasonably comfortable…

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
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 rota_site 36k · 11 months ago
3 votes0 answers3.9k views
What does a batch certificate on a BCH report change about how I read it?

The case in front of me: batch certificate · BCH. This is presented as though it settles something, and I am not convinced it does. I have two documents that appear…

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_Sara_Kuusela 28k · 14 months ago