Sterility testing per USP <71> — need advice

jim_asheville said:

My HPLC chromatogram analysis for certificates of analysis — I sent my batch to Janoshik and here's what the results showed: Main peak retention time:…

COA red flags for certificates of analysis — here's what to look for when reviewing a Certificate of Analysis:

• No HPLC data: If there's no chromatography graph, it's not a real COA
• Exact 100% purity: Suspicious — real testing always shows slight variation
• No batch number: Can't trace back to specific production
• No endotoxin testing: For injectables, this is essential
• Template looks like it was made in Word: Professional labs have standardized formats

I have seen fake COAs that are literally photoshopped. Always verify independently if possible.

CarlaRPh_TPA said:

One addition: an unstated method makes a report close to uninterpretable.

That reframing is the part I needed. I will report back once I have actually tried it.

jim_asheville said:

My HPLC chromatogram analysis for certificates of analysis — I sent my batch to Janoshik and here's what the results showed: Main peak retention time:…

I tested my certificates of analysis batch through Janoshik — 98.7% purity. That's within acceptable range for compounded peptides. Turnaround was 14 business days.

The test costs ~$142 but gives you actual HPLC chromatography data plus mass spec confirmation. For the peace of mind alone, it's worth every penny. I test every new batch from a new vendor.

sarah_TO said:

I have a certificate reporting 99.2% purity and 6.1mg content on a vial sold as 5mg, and I cannot work out whether those two numbers are consistent or…

Community-verified vendors for certificates of analysis: I maintain a spreadsheet of Janoshik-verified test results submitted by community members. Across 50 submitted tests:

• 82% tested at ≥98% purity
• 12% tested at 95-98% purity
• 6% tested at <95% purity (concerning)

The vendors with consistently high purity results are listed in the Vendor Directory. We update monthly based on new community submissions.

Moderator note: a couple of off-topic posts removed.