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Same here! Quite disappointed, I have overdosed that specific batch by 3%. I have all written it down.Thanks you for testing! The result is actually quite okay. I mean, it’s still a UGL, although I was hoping for a more precise result from Venom.
Same here, I have been talking with a few brewers around here and we are all getting odd results. Maybe we all ain't able to brew and that is indeed a possibility but we all test our raws, after that as you well very know it is just as simple as following some numbers on a screen.I really want to see other results.
I believe that Jano must do some evaluation of one of his employees. In every company is one guy that just doesn't care and do a half ass job and Jano I think he has one now.
BUT let's see. I'm looking forward to this.
286.56 / 300 = 96%Enjoy the results!
US FDA and USP Potency Standards.
FDA-approved medications generally must contain active ingredients within +/- 10% of the labeled amount. For compounded preparations, the typical acceptable range is also +/- 10%, with a maximum, in some cases, of up to +/- 20%.
Based on United States Pharmacopeia (USP) standards, which guide pharmacy compounding practices, the information provided is generally accurate. [1, 2, 3]
Compounded Preparations (USP 795 & 797)
• Typical Range: The standard acceptable variability in potency for most compounded nonsterile (USP 795) and sterile (USP 797) preparations is +/- 10% of the labeled strength.
• Maximum Range: Depending on the stability of the ingredient, the specific dosage form, or if the ingredient is complex (such as some proteins), the acceptable range can extend up to +/- 20%.
• Other Ranges: For certain raw powders, potency requirements may be as tight as +/- 2%, while for others it may differ. [5, 6]
FDA-Approved Medications
• General Standards: FDA-approved manufactured drugs must adhere to strict stability and potency standards, typically requiring active ingredients to be within 90%–110% (+/- 10%) of the labeled amount, though some specific drug monographs may differ. [7, 8, 9, 10, 11]
Key Differences
• Compounded Drugs: Are not FDA-approved, meaning the FDA does not evaluate their safety, effectiveness, or quality before they are marketed, although they must be made using specific USP guidelines.
• Acceptable Variability: Because they are made one at a time to individual prescriptions, compounded drugs often have a slightly wider permitted variance (sometimes up to +/- 20%) compared to the strict, consistent manufacturing requirements of FDA-approved drugs. [6, 12, 13, 14, 15]
[1] Understanding Compounding Pharmacies: Requirements and Services
[2] What Is Liquid Medicine From Compounding Pharmacies? - Burt's
[3] Understanding Reference and Working Standards in Pharmaceuticals | farnamshime tajhiz posted on the topic | LinkedIn
[4] ARL Bio Pharma | Labeling Compounded Preparations
[5] THE PCCA BLOG | Notable Changes in the New USP <795>
[6] https://www.arlok.com/sites/default...797 for Compounded Sterile Preparations_0.pdf
[7] https://www.pharmacy.texas.gov/files_pdf/BN/Nov21/D.1.3.pdf
[8] The Scientist’s Guide to Understanding FDA Drug Approval
[9] Compounded Bioidentical Hormone Preparations - The Clinical Utility of Compounded Bioidentical Hormone Therapy - NCBI Bookshelf
[10] Compounding Pharmacies: The Top 5 Questions | Sona Pharmacy + Clinic
[11] Study: Expiration dates have nothing to do with shelf life of drugs
[12] Human Drug Compounding Laws
[13] What Ingredients Can Be Used in Compounded Drugs?
[14] https://www.goodrx.com/drugs/medication-basics/compound-medications
[15] Comparison of three automated compounding devices for parenteral nutrition according to four key technical tests - PMC
The United States Pharmacopeia (USP) establishes that the generally accepted potency range for most compounded and manufactured drug preparations is +/- 10% of the labeled amount, though this can vary from +/- 5% to +/- 20% depending on the specific monograph. These standards, often cited in FDA guidance and 21 CFR 211.192, ensure drug quality, purity, and potency. [1, 2, 3]
Key details regarding USP/FDA potency requirements:
• Standard Range: The common, accepted potency range is 90% –110% (+/- 10%) of the label claim.
• Variations: Potency requirements may be stricter (+/- 5% for potent analgesics) or wider (+/- 20% for some proteins) based on specific USP monographs.
• Regulatory Context: FDA 21 CFR 211.192 requires investigation of any batch that fails to meet these established specifications.
• Compounding: USP 795 & USP 797 standards for compounded preparations frequently reference the +/- 10% tolerance. [1, 2, 4, 5, 6]
[1] 21 CFR 211.192 Production Record Review - Performance Validation
[2] ARL Bio Pharma | Potency Testing Benefits and Requirements
[3] https://qualitymatters.usp.org/what-letters-usp-mean-label-your-medicine
[4] Strength Conversion in Drug Listing
[5] Compounding with Commercial Drugs Can Cause Errors | Pharmacy Times
[6] https://www.usp.org/sites/default/f...stability-testing-compounded-preparations.pdf
(NOTE: these are AI search and inquiry results, not my original work).
@Venom Lab Its a very good result brother. See the information I shared above.Same here! Quite disappointed, I have overdosed that specific batch by 3%. I have all written it down.
I have genuinely no idea how it came out like this. Raws are tested, the scale is an analytical one, I think I can still read numbers on a screen and just pout what it says... So I'm srsly lifting my hands up and I have no clue. Genuinely surprised in a bad way.
Sorry for having you all let down with such a shitty result.
I guess I'll start overdosing my batches of 5-6% and retest it.
I have 10+ labtest incoming including few oils, we will see how they come back.
Well I wasn't expecting this.286.56 / 300 = 96%
That's an excellent result!
@YiL thank you for getting testing
I recently did some AI searches to find the USP/FDA potency requirements because someone a little while ago said he does not accept the +/- 10% standard.
I think a lot of people don't even realize that big official licensed companies follow such a standard and compound pharmacies may follow a +/- 5% to +/-20% standard.
Also, keep in mind that the analytic testing results themselves have an error range and are a process run by humans; like with anything else, humans and measurements are not perfect so there are always error ranges/inconsistencies and tolerances in any measurements or processes.
Two analytic samples from the same exact batch may give slightly different results because the testing procedure itself also has some variance.
Therefore, if we consider the possible variance in production potency (+/- 10%, maybe even +/- 5% to +/- 20%) with the possible variance in the analytic results, the error may compound and give values that people wrongly call "bad" or " disappointing," and some even freak out about (because they may not understand, are ignorant, or just emotional and dramatic).
Overall, it seems that steroid forum communities do not really understand these details and have developed some unrealistic expectations regarding analytic results.
