BPC-157

1. 01/ 08Mass spectrometry

   Identity

   A white powder tells you nothing. It is the one thing about this vial that no amount of looking will settle, which is why the first analysis is not a measure of quality at all. The spectrometer weighs the molecule itself, and the weight either matches the compound printed on the label or the batch never becomes a product.

   Confirms the molecule in the vial is the compound named on the label.

   Held toMW matchMolecular weight matches the target compound

2. 02/ 08Visual

   Appearance

   The only one of the eight you could run yourself. An intact cake sitting in the base of the glass, one solid piece, no browning and nothing drifting. It is looked at before the batch is released, so you are never the first person to.

   Discoloration, clumping or particulates can indicate degradation, contamination or moisture ingress before analytical testing even begins.

   Held toLyophilized powder cakeLyophilized powder cake; free of visible particulates

   On recordPass on all 14 certificates on record.

   

3. 03/ 08HPLC @ 274nm

   Purity

   The figure everyone asks for first, and the one worth reading backwards. The chromatogram separates the target peptide from everything the synthesis left with it, and the specification is a FLOOR: it is the line a batch has to clear, not a number anything is capped at.

   Measures what fraction of the material is the complete target peptide versus synthesis byproducts, truncated sequences or degradation products.

   Held to≥99%

   On recordPass on all 14 certificates on record.

   The target peptideEverything else

4. 04/ 08qPCR

   Microbials

   The only acceptable outcome here is nothing at all. Bacteria, yeast and mold are each assayed separately by qPCR, and there is no partial credit: the specification is not-detected in a full gram, for every analyte on the list.

   Confirms the finished vial is free of viable bacteria, yeast and mold.

   Held toNot detectedNot detected in 1g (all analytes)

   On recordNot detected on all 14 certificates on record.

   • Total aerobic count
   • Enterobacteriaceae
   • Total yeast & mold

5. 05/ 08LCMS

   Mycotoxins

   Four micrograms in a kilogram is four parts in a billion. Against a single gram of material the limit is a hairline, which is exactly why mould metabolites are looked for by instrument rather than by eye: they arrive with raw material at concentrations no inspection could ever catch.

   Mycotoxins are toxic fungal metabolites that can contaminate raw materials.

   Held to<4 µg/kgAflatoxins B1/B2/G1/G2 · Ochratoxin A

   On recordNot detected on all 14 certificates on record.

   • Aflatoxins B1/B2/G1/G2
   • Ochratoxin A
   the limitone gram of material

6. 06/ 08Water Activity Meter

   Moisture Profile

   This is the slow one. A lyophilized cake pulls water out of whatever air reaches it, and that water takes up room the active material used to. 0.65 aw is where microbial growth becomes possible, so the panel draws its line there. A batch is released for being clear of that line, not for touching it.

   Lyophilized peptides absorb atmospheric moisture, which dilutes active content per mg and accelerates degradation.

   Held to<0.65 aw<0.65 aw (threshold for microbial growth)

   On record0.35 to 0.45 aw measured on the 9 certificates that print a reading.

   0recorded0.65 aw1.00

7. 07/ 08GC headspace

   Residual Solvents

   Every synthesis uses solvents. The only question that matters afterwards is what stayed behind, and it is not a question the finished powder answers on its own. Headspace GC reads the vapour standing above the material, where a solvent shows itself long before anything else would.

   Solvents used in synthesis and purification can interfere with biological assays and affect cell viability if they remain in the final product.

   Held toICH Q3CICH Q3C Class 2/3 limits

   On recordBelow the ICH limits on all 14 certificates on record.

   At raw material inspection

   

8. 08/ 08ICPMS

   Elemental Impurities

   Arsenic. Cadmium. Lead. Mercury. Four metals named one at a time rather than folded into a phrase, because the entire purpose of this analysis is to be able to say they are not in the vial in any amount that counts. USP <232> is the standard that decides what counts.

   Heavy metals accumulate in biological systems and interfere with enzyme activity, receptor binding and cell viability.

   Held toUSP <232>Arsenic · Cadmium · Lead · Mercury

   On recordBelow the USP limits on all 14 certificates on record.

   At raw material inspection

   • AsArsenic
   • CdCadmium
   • PbLead
   • HgMercury

Nothing above is specific to BPC-157. It is the standard panel every NuLumin lot is released against: the same methods, the same specifications, batch after batch.