# Gold Standard Analytics > Analytical testing laboratory in Houston, Texas, with every sample filmed from package opening (est. January 2026). HPLC-UV, LC-MS/MS, GC-MS, ICP-MS, endotoxin (LAL) and USP <71> sterility testing for peptides, SARMs, kratom, supplements, cosmetics, raw materials and environmental samples. Certificates issued with a verification code can be checked at /verify. Procedures modelled on ISO/IEC 17025; not accredited. Key facts: 5151 Mitchelldale St A10, Houston, TX 77092. team@goldstandardanalytics.com. Phone (346) 770-3170, answered 24/7. Chain-of-custody video and photos retained three years. Samples retained 90 days. No walk-in drop-off; mail-in only. Prices are per sample and published on each service page. ## Start here - [Homepage](https://www.goldstandardanalytics.com/): what the lab tests, instruments, quality program, refunds - [Verify a certificate](https://www.goldstandardanalytics.com/verify): enter an accession number (format GSA-2026-018432) - [Submit samples](https://www.goldstandardanalytics.com/sample-intake): account, services, samples, panels, payment - [About and contact](https://www.goldstandardanalytics.com/about) ## Services - [Peptide testing: purity, identity and net content](https://www.goldstandardanalytics.com/services/peptide-testing): from $129 per sample - [SARMs and research-compound potency and identity testing](https://www.goldstandardanalytics.com/services/sarms-testing): from $129 per sample - [Dietary supplement label-claim, heavy-metal and microbial testing](https://www.goldstandardanalytics.com/services/dietary-supplement-testing): from $129 per sample - [Cosmetic and skincare active potency, preservative efficacy and microbial testing](https://www.goldstandardanalytics.com/services/cosmetics-testing): from $129 per sample - [Raw material and API identity, assay, residual solvents and water testing](https://www.goldstandardanalytics.com/services/raw-material-api-testing): from $129 per sample - [Petroleum hydrocarbon, BTEX and PAH testing in soil, water and oil](https://www.goldstandardanalytics.com/services/hydrocarbon-testing): scope and price confirmed before submission - [Multi-residue pesticide testing in produce, botanicals, soil and water](https://www.goldstandardanalytics.com/services/pesticide-residue-testing): from $109 per sample - [Drinking water, food and beverage testing for metals, PFAS and mycotoxins](https://www.goldstandardanalytics.com/services/water-food-beverage-testing): from $145 per sample ## Prices - HPLC-MS purity and identity: $129 per sample for peptides, SARMs and research actives, supplements, raw materials and APIs, and cosmetics, any compound or blend, GLP-1s included. With net content (mg per vial or unit): $199. Impurity breakdown: +$49. - Tests: endotoxin (USP <85>) $149; heavy metals (ICP-MS) $199; sterility (USP <71>, 14-day) $199; 3-day bioburden $99, instead of sterility or with it; conformity $49 per extra vial; fentanyl scan $99; enclosure integrity (vial vacuum) $29; pH $49; residual solvents (GC-MS) $299; TFA (ion chromatography) $99; Karl Fischer water $99; solubility (Type I water) $99. Kratom, hemp, pesticide, water and food panels keep their own prices; heavy metals, Karl Fischer, pH and bioburden cost the same wherever they are sold. - Services: unboxing and sample-prep video $49 per sample; custom COA template or colors $9.99 per order. Every package is opened on camera for the chain-of-custody record either way. - Packages take a percentage off the same tests bought one by one and apply automatically when your tests cover one: Bronze (identity, purity and the impurity breakdown) 10% off, Silver (Bronze plus net content and endotoxin) 15%, Gold (Silver plus the 3-day bioburden) 20%, Platinum (every test on the list for the sample type) 25%. For one peptide: Bronze $160.20, Silver $337.45, Gold $396.80, Platinum $1,250.25. Tests a sample type is not sold drop out of its packages, and a test an order’s compounds cannot take, such as TFA with NAD+, drops out of the package for that order. - Volume discounts: 10% off at 10 samples, 15% at 25 and 20% at 50. Standard turnaround is included; expedited adds 50% and priority 100%. - [Gold Standard Membership](https://www.goldstandardanalytics.com/membership): Gold Standard Membership is $199 a month: one free HPLC-MS test a month (identity, purity, net content and impurity breakdown, one sample), 5% off every test after packages and volume discounts, the unboxing and sample-prep video on every sample, a custom COA template or colors, expedited turnaround at no charge and the owner’s direct line for 24/7 support. Cancel online any time; it ends at the end of the paid month. Join at https://www.goldstandardanalytics.com/account/membership or when you sign up; terms at https://www.goldstandardanalytics.com/terms/membership. ## Programs - [Group testing](https://www.goldstandardanalytics.com/group-testing): 2–50 people split one sample and one fee - [Refer and earn](https://www.goldstandardanalytics.com/refer): 20% of a referral's first order, 10% after - [Shop used lab equipment](https://www.goldstandardanalytics.com/shop) and [sell on the marketplace](https://www.goldstandardanalytics.com/sellers) ## Laboratory notes - [How to read our certificates of analysis](https://www.goldstandardanalytics.com/notes/how-to-read-our-coas): A Gold Standard certificate has a fixed structure: header, sample identity, method block, results table, chain-of-custody record and signature. Here is what each part means and how to check it. - [DAD vs VWD in HPLC: what the detector changes about a purity number](https://www.goldstandardanalytics.com/notes/dad-vs-vwd-hplc): Both detectors measure UV absorbance. One measures it at a single wavelength; the other captures a full spectrum at every point of the chromatogram. That difference decides whether a purity result can tell you what the impurities are. - [ISO/IEC 17025 accreditation: what it means and what it does not](https://www.goldstandardanalytics.com/notes/iso-17025-accreditation-explained): ISO/IEC 17025 is the international standard for testing laboratory competence. Accreditation is a third-party audit against it. We operate to its expectations and are not accredited; here is exactly what each phrase means. - [USP <71> sterility vs bioburden: they answer different questions](https://www.goldstandardanalytics.com/notes/usp-71-sterility-vs-bioburden): Sterility testing asks whether any viable organism is present in the units tested. Bioburden counts how many are there. For an injectable, only one of these is the release test. - [Why endotoxin is tested by kinetic chromogenic LAL, and what a PPC is](https://www.goldstandardanalytics.com/notes/why-endotoxin-lal-kinetic): Endotoxin is the cell-wall fragment of gram-negative bacteria that causes fever in an injection even when nothing is alive. 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[Delta 9 Analytical vs Gold Standard Analytics](https://www.goldstandardanalytics.com/compare/delta-9-analytical-kratom) ## Guides - [Is this COA real? Fake certificate checker](https://www.goldstandardanalytics.com/fake-coa-checker) - [How much does peptide testing cost?](https://www.goldstandardanalytics.com/peptide-testing-cost) - [Third-party supplement testing for brands](https://www.goldstandardanalytics.com/third-party-supplement-testing) - [USP <71> sterility testing](https://www.goldstandardanalytics.com/usp-71-sterility-testing) - [USP <85> endotoxin testing](https://www.goldstandardanalytics.com/endotoxin-testing-service) - [Mail-in testing by city](https://www.goldstandardanalytics.com/locations) ## Developers - [Developer overview](https://www.goldstandardanalytics.com/developers) - [API reference](https://www.goldstandardanalytics.com/developers/api) - [OpenAPI 3.1](https://www.goldstandardanalytics.com/api/v1/openapi.json) - [MCP server manifest](https://www.goldstandardanalytics.com/api/mcp-manifest.json) - [Certificate lookup](https://www.goldstandardanalytics.com/api/coa/GSA-2026-018432.json): one certificate as JSON by accession ({accession}.json), CC BY 4.0, no key ## Policies - [Terms of service](https://www.goldstandardanalytics.com/terms) - [Refunds](https://www.goldstandardanalytics.com/refunds) - [Privacy](https://www.goldstandardanalytics.com/privacy) - [Accessibility](https://www.goldstandardanalytics.com/accessibility) - [Compliance](https://www.goldstandardanalytics.com/compliance) ## Optional - [llms-full.txt](https://www.goldstandardanalytics.com/llms-full.txt): expanded version with service methods, instruments and FAQ answers # Expanded detail ## Instruments - Agilent 6490 Triple Quadrupole LC/MS (G6490A, iFunnel, 1290 Infinity II front end) - Agilent 1290 Infinity II UHPLC (G7120A pump, G7167B multisampler, G7116B thermostat, G7114A VWD. Also on the bench: a 1290 Infinity III and a 1260 Infinity II, not pictured) - Agilent 7850 ICP-MS (G8422AA, helium collision cell, SPS 4 autosampler) - Agilent GC-MS with headspace (8890 GC, 5977 MSD, 7697A headspace) - Agilent GC-FID (8890 GC, dual FID, split/splitless inlet) - Charles River Endosafe MCS (Multi-cartridge kinetic chromogenic LAL) - Charles River Endosafe nexgen-PTS, three units (Portable Test System ×3, FDA-licensed LAL cartridges (U.S. License 1197)) - MilliporeSigma Steritest Equinox, two units (Two Equinox systems, closed-system membrane filtration, SterilGARD II BSC) - Microbiology suite (Incubators 20–25 °C and 30–35 °C, selective media, BSC) - Karl Fischer titrator (Coulometric, oven sample changer) ## Service detail ### Peptide testing: purity, identity and net content Research peptides are sold by purity, but purity alone does not say what is in the vial. We pair reversed-phase HPLC-UV at 214 nm with triple-quadrupole LC-MS/MS identity on every sample, at $129, or $199 with net peptide content measured against a reference standard so the milligram on the label can be checked. Endotoxin and sterility are reported on the same accession. - Identity - Purity - Net peptide content - Counter-ion - Water content - Endotoxin - Sterility - Heavy metals Q: Can I see the video of my sample being opened? A: Yes, with the video add-on ($49 per sample) or a Gold Standard Membership. Every package is opened on camera either way, and each container is photographed. Custody video and photos are kept for three years; the retained sample itself is kept about 90 days for verification and review. Q: What happens if my result fails? A: It is published like any other result, with the method, instrument and specification shown. You may order a retest of the retained sample; we never re-run to obtain a better number. Q: How much does peptide testing cost? A: Gold Standard charges one flat price for any peptide or blend, GLP-1s included: $129 per sample for HPLC-MS identity and purity, or $199 with net content (mg per vial). Q: What does the HPLC result mean? A: Purity is the area of the target peak as a percentage of all peaks at 214 nm, where the peptide bond absorbs. It says how much of the UV-absorbing material is the main compound, not what the main compound is; identity by LC-MS/MS answers that. Q: How many vials do I send? A: One sealed vial covers identity, purity and net content. Endotoxin and sterility are destructive and share one extra vial; heavy metals needs another. Q: Do you test semaglutide and tirzepatide? A: Yes, at the same price as any other peptide: $129 for identity and purity, or $199 with net peptide content. Q: Is the result published? A: Every certificate is public under its accession, including failures. You choose whether your name appears. Q: How is this different from the vendor’s COA? A: A vendor COA is issued to the vendor for a sample the vendor chose. Ours is issued for the vial you sent, opened on camera, and verifiable by anyone. ### SARMs and research-compound potency and identity testing Capsules, liquids and powders sold as SARMs are among the most frequently mislabeled products we see: under-dosed, substituted with a cheaper analog, or spiked with a prohormone. We confirm identity by LC-MS/MS precursor and fragment ions, quantify against a certified standard, and screen for the common substitutions on the same run. - Identity - Potency and label claim - Analog and adulterant screen - Heavy metals - Impurity identification Q: Can I see the video of my sample being opened? A: Yes, with the video add-on ($49 per sample) or a Gold Standard Membership. Every package is opened on camera either way, and each container is photographed. Custody video and photos are kept for three years; the retained sample itself is kept about 90 days for verification and review. Q: What happens if my result fails? A: It is published like any other result, with the method, instrument and specification shown. You may order a retest of the retained sample; we never re-run to obtain a better number. Q: What is included for $129? A: Purity by HPLC-UV and identity by LC-MS/MS. Potency and label claim across five units (net content, mg per unit) makes it $199, and the impurity breakdown is $49 more. The analog and adulterant screens are separate tests. Q: Why five capsules? A: Fill weight varies; five units give a mean and range that describe the lot rather than one capsule. Q: Can you tell me what an unknown peak is? A: The single-impurity identification add-on fragments the peak and reports a tentative identity with a confidence level. Q: Do you test liquids? A: Yes, 5 mL minimum; results are reported per mL and per labeled dose. ### Kratom alkaloid, heavy-metal and microbial testing Published surveys have found mitragynine ranging from under 4 mg/g to over 60 mg/g across retail kratom, nickel and lead at concerning levels in most products, and bacterial contamination in the majority. Our panel quantifies mitragynine and 7-hydroxymitragynine separately, runs the FDA-relevant metals by ICP-MS, and screens the microbial limits the American Kratom Association GMP program expects. - Mitragynine - 7-hydroxymitragynine - Alkaloid profile - Heavy metals - Microbial limits - Pesticide residue Q: Can I see the video of my sample being opened? A: Yes, with the video add-on ($49 per sample) or a Gold Standard Membership. Every package is opened on camera either way, and each container is photographed. Custody video and photos are kept for three years; the retained sample itself is kept about 90 days for verification and review. Q: What happens if my result fails? A: It is published like any other result, with the method, instrument and specification shown. You may order a retest of the retained sample; we never re-run to obtain a better number. Q: Do you meet AKA GMP testing requirements? A: The alkaloid, heavy-metal and microbial panels cover what the AKA GMP standards program asks a vendor to test per lot. We are not the certifying body; your auditor reviews our certificates. Q: How much material? A: 25 g of powder covers alkaloids, metals and microbial. Pesticide residue needs another 25 g. Q: Can you test extracts and shots? A: Yes; extracts are diluted and reported per gram and per serving; beverages per mL and per bottle. Q: What are typical mitragynine levels? A: Published surveys report roughly 4–60 mg/g in leaf products; extracts run far higher. We report your number against your label claim. ### Dietary supplement label-claim, heavy-metal and microbial testing Under 21 CFR Part 111 a supplement brand must verify identity, purity, strength and composition, and retailers from Amazon to Costco now ask for the certificate. We quantify the declared active against a certified standard, run ICP-MS metals sensitive enough to evaluate both USP <2232> serving-based limits and California Prop 65 daily limits, and count microbial limits. - Label claim, declared active - Identity - Heavy metals - Microbial limits - Undeclared ingredient screen - Mycotoxins Q: Can I see the video of my sample being opened? A: Yes, with the video add-on ($49 per sample) or a Gold Standard Membership. Every package is opened on camera either way, and each container is photographed. Custody video and photos are kept for three years; the retained sample itself is kept about 90 days for verification and review. Q: What happens if my result fails? A: It is published like any other result, with the method, instrument and specification shown. You may order a retest of the retained sample; we never re-run to obtain a better number. Q: Which limits do you report metals against? A: Both USP <2232> serving-based limits and California Prop 65 MADL/NSRL values, per your labeled serving. Q: Can I use this for Amazon? A: Amazon’s dietary supplement policy asks for a COA from an ISO 17025-accredited or otherwise qualified lab; we are not accredited. Many sellers submit our certificates; confirm with Amazon’s current policy for your category. Q: What if my active has no reference standard? A: We source a certified standard where one exists; otherwise we tell you before testing and quote a method-development path. Q: How much product? A: One sealed retail unit for label claim; a second for metals; a third for microbial. ### Cosmetic and skincare active potency, preservative efficacy and microbial testing The Modernization of Cosmetics Regulation Act requires brands to substantiate safety and keep records. We quantify the actives you claim, run the 28-day USP <51> antimicrobial effectiveness challenge on your finished formula, count microbial limits, and report heavy metals by ICP-MS, so the safety file holds real numbers. - Active potency - Preservative efficacy - Microbial limits - Heavy metals - Preservative assay - Restricted substances Q: Can I see the video of my sample being opened? A: Yes, with the video add-on ($49 per sample) or a Gold Standard Membership. Every package is opened on camera either way, and each container is photographed. Custody video and photos are kept for three years; the retained sample itself is kept about 90 days for verification and review. Q: What happens if my result fails? A: It is published like any other result, with the method, instrument and specification shown. You may order a retest of the retained sample; we never re-run to obtain a better number. Q: What does MoCRA require me to test? A: MoCRA requires adequate safety substantiation and records; it does not name specific tests. Preservative efficacy, microbial limits and heavy metals are the tests FDA and retailers most often expect in the file. Q: How long does USP <51> take? A: 28 days of incubation plus setup and reporting, about 30 days total. It cannot be rushed. Q: How much product? A: 100 g for preservative efficacy on its own; 50 g covers actives and microbial; a sealed retail unit for metals. Q: Do you test sunscreens? A: Zinc oxide and titanium dioxide content by ICP-MS and organic filters by HPLC-UV. We do not run SPF (in vivo) testing. ### Raw material and API identity, assay, residual solvents and water testing Incoming-goods verification is where a supplier certificate meets an independent number. We confirm identity by mass spectrometry, assay against a reference standard, and run the compendial residual-solvent, water and elemental-impurity tests that a release specification calls for. - Identity - Assay - Residual solvents - Water content - Elemental impurities - Endotoxin Q: Can I see the video of my sample being opened? A: Yes, with the video add-on ($49 per sample) or a Gold Standard Membership. Every package is opened on camera either way, and each container is photographed. Custody video and photos are kept for three years; the retained sample itself is kept about 90 days for verification and review. Q: What happens if my result fails? A: It is published like any other result, with the method, instrument and specification shown. You may order a retest of the retained sample; we never re-run to obtain a better number. Q: How much material? A: 500 mg covers identity and assay. Residual solvents and water each consume about 200 mg more. Q: Can you test against my specification? A: Yes. Send the specification with the order and the certificate reports each result against your acceptance criteria. Q: Do you do full USP monograph testing? A: We run the monograph tests within our scope: identity, assay, residual solvents, water, elemental impurities, endotoxin. A test outside our scope is stated as not performed. ### Petroleum hydrocarbon, BTEX and PAH testing in soil, water and oil TCEQ Method 1005 is the Texas method for total petroleum hydrocarbons: an n-pentane extraction and GC-FID with n-alkane markers at nC6, nC12, nC28 and nC35 so the data user can see the carbon-range distribution. We run 1005 with the chromatogram on the certificate, then BTEX by GC-MS and the 16 priority PAHs where the >nC12 range triggers them. - Total petroleum hydrocarbons - TPH fractionation - BTEX and MTBE - PAH 16 - Metals Q: Can I see the video of my sample being opened? A: Yes, with the video add-on ($49 per sample) or a Gold Standard Membership. Every package is opened on camera either way, and each container is photographed. Custody video and photos are kept for three years; the retained sample itself is kept about 90 days for verification and review. Q: What happens if my result fails? A: It is published like any other result, with the method, instrument and specification shown. You may order a retest of the retained sample; we never re-run to obtain a better number. Q: Is TCEQ 1005 accepted for PST closure? A: Method 1005 is the TCEQ TPH method for the PST program; 418.1 and 8015 data are not accepted after 2001. Confirm program-specific requirements with your TCEQ project manager; we are not NELAP-accredited. Q: How should I collect water samples? A: Two 1 L amber glass bottles, preserved as directed on the label, on ice, received within 48 hours. Q: When are PAHs required? A: TCEQ guidance calls for PAH analysis on the highest >nC12 sample per source area when that range is detected. ### Multi-residue pesticide testing in produce, botanicals, soil and water Pesticides span polar and non-polar chemistries, so one instrument misses half the list. We extract by QuEChERS and run both LC-MS/MS and GC-MS multi-residue panels, with glyphosate and AMPA as a separate derivatized method because they do not survive a generic screen. - LC-amenable residues - GC-amenable residues - Glyphosate and AMPA - Heavy metals Q: Can I see the video of my sample being opened? A: Yes, with the video add-on ($49 per sample) or a Gold Standard Membership. Every package is opened on camera either way, and each container is photographed. Custody video and photos are kept for three years; the retained sample itself is kept about 90 days for verification and review. Q: What happens if my result fails? A: It is published like any other result, with the method, instrument and specification shown. You may order a retest of the retained sample; we never re-run to obtain a better number. Q: How many pesticides are on the panel? A: Over 350 across the LC-MS/MS and GC-MS lists; the analyte list ships with the certificate. Q: Why is glyphosate separate? A: It is too polar for generic extraction and ionization; it needs derivatization and its own calibration. Q: What sample size? A: 500 g produce, 50 g dried material, 250 g soil, 1 L water; glyphosate needs 50 g more. ### Drinking water, food and beverage testing for metals, PFAS and mycotoxins EPA Methods 537.1 and 533 are complementary: together they measure 29 unique PFAS in drinking water, and neither is valid for wastewater or soil, which need Method 1633. We run both drinking-water methods in lab-supplied polypropylene bottles with Trizma preservative, metals by EPA 200.8 ICP-MS to the 10 µg/L lead trigger level, and Closer to Zero panels for food. - Metals - PFAS, drinking water - PFAS, other matrices - Food metals - Mycotoxins Q: Can I see the video of my sample being opened? A: Yes, with the video add-on ($49 per sample) or a Gold Standard Membership. Every package is opened on camera either way, and each container is photographed. Custody video and photos are kept for three years; the retained sample itself is kept about 90 days for verification and review. Q: What happens if my result fails? A: It is published like any other result, with the method, instrument and specification shown. You may order a retest of the retained sample; we never re-run to obtain a better number. Q: Can I use this for compliance reporting? A: Compliance samples for public water systems must go to a state-certified laboratory; we are not certified. Our results serve homeowners, brands and pre-compliance screening. Q: How do I sample for PFAS? A: Request bottles in the order notes. Do not use glass, do not wear water-resistant clothing while sampling, and ship on ice within 48 hours. Q: What is Closer to Zero? A: FDA’s program setting action levels for lead, arsenic, cadmium and mercury in foods for babies and young children. We report against the current action levels. ## Articles (full text) ### How to read our certificates of analysis Every certificate we sign follows the same layout, so once you have read one you can read all of them. This walkthrough uses the peptide panel as the example; kratom, cannabis and supplement certificates share every section and differ only in the analytes listed. The header The top of the page carries the accession number (format GSA-2026-018432), the issue date, the client name or blind code, the instrument IDs used and the certificate version. The accession number is the primary key for everything else: type it into the verify field on our site and the public record must match the paper in your hand. If it does not resolve, the document is not ours. Sample identity Declared compound, declared lot or batch, matrix (lyophilized powder, capsule, leaf, tincture), container count received, container condition on opening and the intake photograph reference. The declared values are what you told us; the identity result further down is what we measured. The two are kept apart on purpose. Method block Each test names its method, instrument and reporting limit. A purity row will read, for example, "HPLC-UV, Agilent 1290 Infinity II, VWD 214 nm, RP-C18, LOQ 0.05%". An identity row will read "LC-MS/MS, Agilent 6490, observed m/z vs theoretical, tolerance ±0.1 Da". The method line is how another laboratory would reproduce the result. Results table Analyte | The substance or property measured | Matches the panel you ordered Result | The measured value with units and significant figures | Compare against the specification column, not against a marketing claim Specification | The acceptance limit and its source (USP, client, method) | A missing spec means the test is report-only Verdict | Pass, Fail or Report | One Fail on any row fails the panel; we do not average it away Uncertainty | Expanded uncertainty where the method supports it | A result inside the spec but within its uncertainty of the limit is flagged Chain-of-custody record Carrier tracking number, receipt timestamp, opening video reference, blind code assigned, analyst initials for preparation, analysis and review, and the retained-sample location. Videos and photographs are kept three years. The photographs are viewable from the certificate page, and so is the video when the order has the video add-on ($49 per sample) or the client is a Gold Standard member. Signature and hash The reviewing analyst and the releasing scientist both sign. Beneath the signatures is a SHA-256 hash of the signed PDF. Recompute the hash of the file you were sent; if it differs from the one in our public record, the file has been altered after release. If a Gold Standard COA doesn’t resolve in our public database, it isn’t one of ours. Three checks that take under a minute - Verify the accession number on our site and confirm the compound, lot and date match. - Compare the hash printed on the PDF with the hash in the public record. - If the certificate page shows the unboxing video, watch it and confirm the container matches what you shipped. ### DAD vs VWD in HPLC: what the detector changes about a purity number A variable wavelength detector (VWD) reads absorbance at one wavelength you set before the run. A diode array detector (DAD) records the whole UV-visible spectrum, typically 190 to 640 nm, at every time point. Both produce a chromatogram; only one produces a spectrum for each peak. Why it matters for peptides Peptide purity by HPLC is an area-percent calculation: the main peak area divided by the total area of all peaks. If an impurity does not absorb at the wavelength you chose, it is invisible and purity is overstated. With a VWD at 214 nm you cannot know what you missed. With a DAD you can pull the spectrum of every minor peak, confirm it absorbs like a peptide bond, and check whether two peaks that co-elute are actually one compound. What each detector answers Area-percent purity at 214 nm | Yes | Yes Peak purity (is the main peak one compound?) | No | Yes, by spectral comparison across the peak Identify an unexpected peak class | No | Partly, from its UV spectrum Report purity at 220 and 280 nm from the same run | No, one wavelength per run | Yes, any wavelength after the fact Baseline noise at trace level | Slightly lower | Comparable on current hardware What we run Our Agilent 1290 Infinity II stack uses a variable wavelength detector (G7114A). Purity is reported as area percent at 214 nm for comparability with the wider industry, identity is confirmed separately by LC-MS/MS, and the certificate makes no spectral peak-purity claim. Where a client specification calls for 220 or 280 nm, the sample is run again at that wavelength. A purity number without a detector and wavelength beside it is not a purity number. Ask which detector produced it. Where VWD is still fine Routine release of a well-characterized compound with a validated method and a known impurity profile. In that setting the wavelength has already been chosen for the impurities that matter. For a compound you have never tested from a supplier you have never used, a DAD run is the safer first look. ### ISO/IEC 17025 accreditation: what it means and what it does not ISO/IEC 17025 is a standard, not a certificate. It sets requirements for a testing laboratory’s impartiality, personnel, equipment, method validation, measurement traceability, handling of samples, quality control and reporting. A laboratory can follow all of it without anyone checking. Accreditation is when an accreditation body (in the United States, A2LA, ANAB, PJLA and others) audits the laboratory against the standard and lists specific methods on a published scope. Aligned, not accredited Gold Standard Analytics works to procedures modelled on ISO/IEC 17025. We are not accredited. Our SOPs, calibration program, method validation, second-analyst review and record retention follow the standard, and we make those records public so you can check them without an auditor in between. We use that phrasing on every page because the two things are different, and a buyer deciding on a laboratory should know which one they are getting. What accreditation does tell you - An independent assessor visited and reviewed the quality system, personnel records and a sample of test records. - The laboratory participated in proficiency testing for the methods on its scope. - The scope document lists exactly which methods and matrices were assessed. Methods not on the scope are not covered by the accreditation. - Reassessment happens on a cycle, usually every two years, with surveillance in between. What accreditation does not tell you - That a particular certificate was produced under the accredited method. Check the scope and the certificate’s method line. - That the sample tested was the sample you sent. Accreditation covers the laboratory’s process, not the shipping and custody before receipt. - That the result is public or checkable. Most accredited laboratories issue private PDFs with no lookup. - That the instrument was in calibration on the day. That is in the laboratory’s records, which accreditation requires but does not publish. How to evaluate a laboratory either way Scope of methods | Published scope document | Method list per service page, with instrument IDs Calibration records | Available on audit | Published on the quality page, filterable by instrument Proficiency testing | Required on scope | Reference standards lot-traced; inter-laboratory comparisons published as run Certificate verification | Usually by email to the lab | Public lookup by accession, SHA-256 hash Chain of custody evidence | Internal records | Photographs on the certificate page, and the opening video when the order includes it Our position We intend to pursue accreditation for the methods with the highest client demand once the laboratory has twelve months of records under the current quality system. Until a scope certificate exists, we will not describe ourselves as accredited, and no certificate we issue will carry an accreditation mark. ### USP <71> sterility vs bioburden: they answer different questions Both tests grow microorganisms from a sample. The difference is the question, the method and what a result allows you to claim. USP <71> sterility A qualitative test. Sample is filtered through a 0.45 µm membrane in a closed system, the membrane is transferred to two media (tryptic soy broth for aerobes and fungi, fluid thioglycollate for anaerobes) and incubated fourteen days. Any growth in any canister is a failure. The result is Sterile or Not sterile for the units tested; the standard also specifies how many units to test based on batch size. Bioburden, USP <61> and <62> A quantitative test. Sample is plated or filtered and colonies are counted after incubation, reported as CFU per gram or per unit, with separate enumeration of total aerobic microbial count and total yeast and mould count. USP <62> adds tests for specified organisms such as E. coli, Salmonella, Pseudomonas aeruginosa and Staphylococcus aureus. Bioburden is the right test for non-sterile products: capsules, powders taken orally, topicals, kratom leaf. Question | Is anything alive in it? | How much is alive in it, and is any of it a specified pathogen? Result | Sterile / Not sterile | CFU/g or CFU/unit, plus presence or absence of specified organisms Incubation | 14 days | 3 to 5 days (bacteria), 5 to 7 days (yeast and mould) Applies to | Injectables, ophthalmics, implants | Oral, topical, botanical and raw material products Destroys the unit | Yes | Yes Can it release an injectable | Yes, with USP <85> endotoxin | No Why bioburden cannot stand in for sterility A low bioburden count on an injectable tells you the batch was clean before the final filter or autoclave cycle. It does not tell you the cycle worked. Sterility testing is the only test that asks the release question directly, and the fourteen-day incubation exists because slow-growing organisms do not show in five. What we run Sterility is performed on two MilliporeSigma Steritest Equinox pumps in a SterilGARD II class II biosafety cabinet, using single-use closed canisters so the membrane is never exposed to room air. Media growth promotion is verified per lot. Bioburden and specified organisms are run in the microbiology suite by membrane filtration or pour plate depending on the matrix. Both require an extra unit beyond the chemistry sample. For an injectable peptide, the release set is identity, purity, net content, USP <85> endotoxin and USP <71> sterility. A bioburden count is not a substitute for the last one. ### Why endotoxin is tested by kinetic chromogenic LAL, and what a PPC is A sample can pass sterility and still cause a pyrogenic reaction, because endotoxin is a lipopolysaccharide left behind by bacteria that are no longer alive. Autoclaving kills organisms; it does not remove endotoxin. That is why USP <85> is a separate release test for anything injected. The LAL reaction Limulus amebocyte lysate, derived from horseshoe crab blood, clots in the presence of endotoxin. Kinetic chromogenic assays measure how fast a colour develops as the reaction proceeds; faster onset means more endotoxin. The result is read against a standard curve and reported in endotoxin units per millilitre or per milligram. Positive product control Every sample is run twice: once as-is and once spiked with a known quantity of endotoxin. If the spiked recovery falls outside 50 to 200 percent, the sample is interfering with the reaction (inhibiting or enhancing it) and the unspiked result cannot be trusted. The PPC is what turns a number into a valid number. A certificate that reports endotoxin without a PPC recovery has skipped the control. Standard curve | Reader and lysate are responding correctly | Cartridge lot and curve acceptance in the method block Negative control | Water and consumables are endotoxin-free | Reported as below LOQ Positive product control | Your sample is not interfering | Spike recovery in percent, next to the result Maximum valid dilution | How far the sample can be diluted and still detect the limit | Dilution used and MVD in the method block What we run Three Charles River Endosafe nexgen-PTS readers with single-use cartridges. Each cartridge carries its own standard curve and is calibrated by Charles River before it ships, so there is no in-house standard curve to drift. The limit for a peptide is calculated from the intended dose per USP <85>, K/M, and printed beside the result so the pass is checkable. Endotoxin does not require a second vial when ordered with sterility; the two share one unit. Ordered alone it is destructive and needs its own vial.