{"id":11495,"date":"2026-08-22T10:13:51","date_gmt":"2026-08-22T10:13:51","guid":{"rendered":"https:\/\/nonsensia.pl\/certificate-of-analysis-specimen\/"},"modified":"2026-08-22T10:13:51","modified_gmt":"2026-08-22T10:13:51","slug":"certificate-of-analysis-specimen","status":"publish","type":"page","link":"https:\/\/lustro.nonsensia.pl\/pl\/certificate-of-analysis-specimen\/","title":{"rendered":"Certificate of Analysis \u2014 specimen template"},"content":{"rendered":"<style>\n.coa{--ink:#16202b;--muted:#5a6470;--line:#c9d0d8;line-height:1.55;color:var(--ink)}\n.coa h2{margin-top:2em}\n.coa h3{margin-top:1.4em;font-size:1.05em;text-transform:uppercase;letter-spacing:.04em}\n.coa-banner{border:2px solid #b02a37;background:#fdf3f4;padding:1em 1.2em;margin:1.5em 0;font-weight:600}\n.coa-note{border-left:4px solid #35618f;background:#f2f6fb;padding:1em 1.2em;margin:1.4em 0}\n.coa-sheet{border:1px solid var(--line);padding:1.6em 1.8em;margin:1.6em 0;background:#fff;position:relative;overflow:hidden}\n.coa-sheet::before{content:\"SPECIMEN\";position:absolute;top:38%;left:50%;transform:translate(-50%,-50%) rotate(-24deg);font-size:5.2em;font-weight:800;color:rgba(176,42,55,.09);letter-spacing:.12em;pointer-events:none;white-space:nowrap}\n.coa-head{display:flex;flex-wrap:wrap;gap:1.5em;justify-content:space-between;border-bottom:2px solid var(--ink);padding-bottom:1em;margin-bottom:1.2em}\n.coa-head .who{font-size:.92em;color:var(--muted)}\n.coa-title{font-size:1.5em;font-weight:700;letter-spacing:.03em;margin:0}\n.coa-wrap{width:100%;overflow-x:auto;margin:1em 0}\n.coa-tb{width:100%;min-width:560px;border-collapse:collapse;font-size:.9em}\n.coa-tb th,.coa-tb td{border:1px solid var(--line);padding:.45em .6em;text-align:left;vertical-align:top}\n.coa-tb thead th{background:#eef1f4;font-weight:700}\n.coa-tb .fill{background:#fffdf3;color:#8a6d1f;font-style:italic}\n.coa-kv{width:100%;border-collapse:collapse;font-size:.92em;margin:.6em 0}\n.coa-kv th{width:34%;text-align:left;padding:.35em .6em .35em 0;font-weight:600;vertical-align:top}\n.coa-kv td{padding:.35em 0;border-bottom:1px dotted var(--line)}\n.coa-sign{display:flex;flex-wrap:wrap;gap:2em;margin-top:2em;padding-top:1.2em;border-top:1px solid var(--line)}\n.coa-sign div{flex:1 1 220px}\n.coa-sign .line{border-bottom:1px solid var(--ink);height:2.4em;margin-bottom:.35em}\n.coa-sign small{color:var(--muted)}\n.coa-legal{font-size:.86em;color:var(--muted)}\n@media print{.coa-banner,.site-header,.site-footer{display:none}.coa-sheet{border:none;padding:0}}\n<\/style>\n<div class=\"coa\">\n<div class=\"coa-banner\">\nThis page is a <strong>blank specimen template<\/strong>. It shows the layout, parameter set and methods used on our Certificates of Analysis. It contains <strong>no measured values<\/strong> and is <strong>not a certificate for any batch<\/strong>. For kilogram-scale orders, the controlling document for the delivered material is the signed Certificate of Analysis issued for that specific batch and shipped with it.\n<\/div>\n<p>A Certificate of Analysis is the document that turns a container of powder into a reference standard. It states what was measured, by which method, against which specification, and who released the result. This page sets out exactly what our certificates contain, so a quality unit can check the format against its own incoming-goods procedure before placing an order rather than after receiving the goods.<\/p>\n<h2>Standards the format follows<\/h2>\n<p>The template is built around the documentary conventions a European laboratory is expected to work to. Where a norm applies to the material rather than to the document, it is named against the relevant parameter instead of claimed globally.<\/p>\n<div class=\"coa-wrap\">\n<table class=\"coa-tb\">\n<caption style=\"text-align:left;font-weight:600;padding-bottom:.4em\">Table A. Reference framework<\/caption>\n<thead>\n<tr>\n<th style=\"width:30%\">Instrument<\/th>\n<th style=\"width:38%\">Scope<\/th>\n<th>Application in this document<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>Regulation (EC) No 1272\/2008 (CLP)<\/td>\n<td>Classification, labelling and packaging of substances<\/td>\n<td>Hazard classification, signal word, H- and P-statements reproduced on the certificate and on the container label<\/td>\n<\/tr>\n<tr>\n<td>Regulation (EC) No 1907\/2006 (REACH)<\/td>\n<td>Registration, evaluation, authorisation and restriction of chemicals<\/td>\n<td>Supply status of the substance; Safety Data Sheet provided in accordance with Annex II<\/td>\n<\/tr>\n<tr>\n<td>Commission Regulation (EU) 2020\/878<\/td>\n<td>Format and content of Safety Data Sheets<\/td>\n<td>SDS accompanying each batch follows this 16-section structure<\/td>\n<\/tr>\n<tr>\n<td>ISO\/IEC 17025<\/td>\n<td>Competence of testing and calibration laboratories<\/td>\n<td>Named against each analytical result where the test was performed under an accredited scope; otherwise stated as non-accredited<\/td>\n<\/tr>\n<tr>\n<td>ISO 17034<\/td>\n<td>Competence of reference material producers<\/td>\n<td>Applies where material is issued as a certified reference material (CRM); a non-certified reference material is labelled as such, without implying CRM status<\/td>\n<\/tr>\n<tr>\n<td>ICH Q2(R2)<\/td>\n<td>Validation of analytical procedures<\/td>\n<td>Validation status declared for each quantitative method used<\/td>\n<\/tr>\n<tr>\n<td>ICH Q3C(R8)<\/td>\n<td>Residual solvents<\/td>\n<td>Class 1, 2 and 3 solvent limits applied to the residual-solvent result<\/td>\n<\/tr>\n<tr>\n<td>ICH Q3D(R2)<\/td>\n<td>Elemental impurities<\/td>\n<td>Screening basis for the elemental-impurity result<\/td>\n<\/tr>\n<tr>\n<td>Ph. Eur. \/ USP general chapters<\/td>\n<td>Pharmacopoeial test methods<\/td>\n<td>Cited by chapter number where a compendial method is used (e.g. water determination, residue on ignition)<\/td>\n<\/tr>\n<tr>\n<td>ISO\/IEC Guide 98-3 (GUM)<\/td>\n<td>Expression of uncertainty in measurement<\/td>\n<td>Basis for the expanded uncertainty stated against the assay value<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<\/div>\n<div class=\"coa-note\">\n<p><strong>An honest word about accreditation claims.<\/strong> A certificate that names ISO\/IEC 17025 or ISO 17034 in its header without stating the scope and the accreditation body is decoration, not evidence. On our certificates the accreditation status is declared <em>per test<\/em>: accredited tests carry the body and scope reference, non-accredited tests say so plainly. If a supplier will not tell you which of their results are inside an accredited scope, that is information in itself.<\/p>\n<\/div>\n<h2>The certificate<\/h2>\n<div class=\"coa-sheet\">\n<div class=\"coa-head\">\n<div>\n<p class=\"coa-title\">CERTIFICATE OF ANALYSIS<\/p>\n<div class=\"who\">Document no. <span class=\"fill\">[COA-YYYY-NNNN]<\/span> &middot; Revision <span class=\"fill\">[00]<\/span> &middot; Issued <span class=\"fill\">[DD Month YYYY]<\/span><\/div>\n<\/div>\n<div class=\"who\">\n<strong>[Supplier legal name]<\/strong><br \/>\n[Registered address]<br \/>\n[VAT \/ EORI number]<br \/>\n[e-mail] &middot; [telephone]\n<\/div>\n<\/div>\n<h3>1. Product identification<\/h3>\n<table class=\"coa-kv\">\n<tr>\n<th>Product name<\/th>\n<td>Oxiracetam<\/td>\n<\/tr>\n<tr>\n<th>Chemical name (IUPAC)<\/th>\n<td>2-(4-hydroxy-2-oxopyrrolidin-1-yl)acetamide<\/td>\n<\/tr>\n<tr>\n<th>Synonyms<\/th>\n<td>4-hydroxypiracetam; 4-hydroxy-2-oxo-1-pyrrolidineacetamide<\/td>\n<\/tr>\n<tr>\n<th>Catalogue number<\/th>\n<td class=\"fill\">[cat. no.]<\/td>\n<\/tr>\n<tr>\n<th>CAS Registry Number<\/th>\n<td>62613-82-5<\/td>\n<\/tr>\n<tr>\n<th>EC Number<\/th>\n<td>636-370-0<\/td>\n<\/tr>\n<tr>\n<th>UNII<\/th>\n<td>P7U817352G<\/td>\n<\/tr>\n<tr>\n<th>Molecular formula<\/th>\n<td>C<sub>6<\/sub>H<sub>10<\/sub>N<sub>2<\/sub>O<sub>3<\/sub><\/td>\n<\/tr>\n<tr>\n<th>Molecular mass<\/th>\n<td>158.16 g&middot;mol<sup>&minus;1<\/sup> (monoisotopic 158.06914 Da)<\/td>\n<\/tr>\n<tr>\n<th>InChIKey<\/th>\n<td>IHLAQQPQKRMGSS-UHFFFAOYSA-N<\/td>\n<\/tr>\n<tr>\n<th>Stereochemistry<\/th>\n<td>Racemic (RS); one stereocentre at C-4<\/td>\n<\/tr>\n<tr>\n<th>Material category<\/th>\n<td class=\"fill\">[non-certified reference material \/ CRM under ISO 17034 \u2014 delete as applicable]<\/td>\n<\/tr>\n<\/table>\n<h3>2. Batch data<\/h3>\n<table class=\"coa-kv\">\n<tr>\n<th>Batch \/ lot number<\/th>\n<td class=\"fill\">[lot]<\/td>\n<\/tr>\n<tr>\n<th>Manufacturing date<\/th>\n<td class=\"fill\">[DD Month YYYY]<\/td>\n<\/tr>\n<tr>\n<th>Date of analysis<\/th>\n<td class=\"fill\">[DD Month YYYY]<\/td>\n<\/tr>\n<tr>\n<th>Retest date<\/th>\n<td class=\"fill\">[DD Month YYYY]<\/td>\n<\/tr>\n<tr>\n<th>Quantity in this unit<\/th>\n<td class=\"fill\">[1000 mg]<\/td>\n<\/tr>\n<tr>\n<th>Container \/ closure<\/th>\n<td class=\"fill\">[amber glass vial, PTFE-lined cap]<\/td>\n<\/tr>\n<tr>\n<th>Country of manufacture<\/th>\n<td class=\"fill\">[country]<\/td>\n<\/tr>\n<\/table>\n<h3>3. Analytical results<\/h3>\n<div class=\"coa-wrap\">\n<table class=\"coa-tb\">\n<thead>\n<tr>\n<th style=\"width:23%\">Test<\/th>\n<th style=\"width:27%\">Method<\/th>\n<th style=\"width:22%\">Specification<\/th>\n<th style=\"width:16%\">Result<\/th>\n<th style=\"width:12%\">Accredited<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>Appearance<\/td>\n<td>Visual examination<\/td>\n<td>White to off-white crystalline powder<\/td>\n<td class=\"fill\">[result]<\/td>\n<td class=\"fill\">[Y\/N]<\/td>\n<\/tr>\n<tr>\n<td>Identity A \u2014 infrared<\/td>\n<td>FTIR (KBr) or ATR-IR vs. reference spectrum<\/td>\n<td>Conforms to reference<\/td>\n<td class=\"fill\">[conforms]<\/td>\n<td class=\"fill\">[Y\/N]<\/td>\n<\/tr>\n<tr>\n<td>Identity B \u2014 NMR<\/td>\n<td><sup>1<\/sup>H and <sup>13<\/sup>C NMR<\/td>\n<td>Conforms to structure<\/td>\n<td class=\"fill\">[conforms]<\/td>\n<td class=\"fill\">[Y\/N]<\/td>\n<\/tr>\n<tr>\n<td>Identity C \u2014 mass<\/td>\n<td>MS, molecular ion<\/td>\n<td><em>m\/z<\/em> consistent with 158.07<\/td>\n<td class=\"fill\">[result]<\/td>\n<td class=\"fill\">[Y\/N]<\/td>\n<\/tr>\n<tr>\n<td>Assay (purity)<\/td>\n<td>HPLC-UV, area normalisation; ICH Q2(R2) validated<\/td>\n<td>&ge; 99.0 %<\/td>\n<td class=\"fill\">[% &plusmn; U]<\/td>\n<td class=\"fill\">[Y\/N]<\/td>\n<\/tr>\n<tr>\n<td>Single largest impurity<\/td>\n<td>HPLC-UV, area normalisation<\/td>\n<td>Report result<\/td>\n<td class=\"fill\">[%]<\/td>\n<td class=\"fill\">[Y\/N]<\/td>\n<\/tr>\n<tr>\n<td>Total related substances<\/td>\n<td>HPLC-UV, area normalisation<\/td>\n<td>Report result<\/td>\n<td class=\"fill\">[%]<\/td>\n<td class=\"fill\">[Y\/N]<\/td>\n<\/tr>\n<tr>\n<td>Enantiomeric composition<\/td>\n<td>Chiral HPLC<\/td>\n<td>Racemic, nominally 50:50<\/td>\n<td class=\"fill\">[R:S ratio]<\/td>\n<td class=\"fill\">[Y\/N]<\/td>\n<\/tr>\n<tr>\n<td>Water content<\/td>\n<td>Karl Fischer (Ph. Eur. 2.5.12) or loss on drying (Ph. Eur. 2.2.32)<\/td>\n<td>Report result<\/td>\n<td class=\"fill\">[% w\/w]<\/td>\n<td class=\"fill\">[Y\/N]<\/td>\n<\/tr>\n<tr>\n<td>Residue on ignition \/ sulphated ash<\/td>\n<td>Ph. Eur. 2.4.14, gravimetric<\/td>\n<td>Report result<\/td>\n<td class=\"fill\">[% w\/w]<\/td>\n<td class=\"fill\">[Y\/N]<\/td>\n<\/tr>\n<tr>\n<td>Residual solvents<\/td>\n<td>GC headspace; ICH Q3C(R8)<\/td>\n<td>Within ICH Q3C limits<\/td>\n<td class=\"fill\">[result]<\/td>\n<td class=\"fill\">[Y\/N]<\/td>\n<\/tr>\n<tr>\n<td>Elemental impurities<\/td>\n<td>ICP-MS; ICH Q3D(R2) screening<\/td>\n<td>Report result<\/td>\n<td class=\"fill\">[result]<\/td>\n<td class=\"fill\">[Y\/N]<\/td>\n<\/tr>\n<tr>\n<td>Melting range <em>(if determined)<\/em><\/td>\n<td>Ph. Eur. 2.2.14, capillary method<\/td>\n<td>Report result<\/td>\n<td class=\"fill\">[&deg;C]<\/td>\n<td class=\"fill\">[Y\/N]<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<\/div>\n<h3>4. Measurement traceability and uncertainty<\/h3>\n<table class=\"coa-kv\">\n<tr>\n<th>Assay traceability<\/th>\n<td class=\"fill\">[named primary standard \/ certified reference material and its issuing body]<\/td>\n<\/tr>\n<tr>\n<th>Balance calibration<\/th>\n<td class=\"fill\">[calibration certificate reference, traceable to national standards]<\/td>\n<\/tr>\n<tr>\n<th>Expanded uncertainty of assay<\/th>\n<td class=\"fill\">[&plusmn; x.x % absolute, coverage factor k = 2, approx. 95 % confidence, per ISO\/IEC Guide 98-3]<\/td>\n<\/tr>\n<tr>\n<th>Reference spectra used<\/th>\n<td class=\"fill\">[internal reference spectrum ID \/ public deposit]<\/td>\n<\/tr>\n<\/table>\n<h3>5. Classification and labelling (CLP)<\/h3>\n<table class=\"coa-kv\">\n<tr>\n<th>Signal word<\/th>\n<td>Warning<\/td>\n<\/tr>\n<tr>\n<th>Hazard classes<\/th>\n<td>Skin Irrit. 2; Eye Irrit. 2A<\/td>\n<\/tr>\n<tr>\n<th>Hazard statements<\/th>\n<td>H315 Causes skin irritation; H319 Causes serious eye irritation<\/td>\n<\/tr>\n<tr>\n<th>Precautionary statements<\/th>\n<td>P264; P264+P265; P280; P302+P352; P305+P351+P338; P321; P332+P317; P337+P317; P362+P364<\/td>\n<\/tr>\n<tr>\n<th>Basis of classification<\/th>\n<td>Aggregated notification, ECHA Classification and Labelling Inventory<\/td>\n<\/tr>\n<tr>\n<th>Safety Data Sheet<\/th>\n<td>Supplied in the 16-section format of Regulation (EU) 2020\/878; SDS revision <span class=\"fill\">[rev \/ date]<\/span><\/td>\n<\/tr>\n<\/table>\n<h3>6. Storage and transport<\/h3>\n<table class=\"coa-kv\">\n<tr>\n<th>Storage<\/th>\n<td>Sealed container, cool and dry, protected from light. Hygroscopic \u2014 equilibrate a refrigerated container to ambient temperature before opening.<\/td>\n<\/tr>\n<tr>\n<th>Transport classification<\/th>\n<td class=\"fill\">[not classified as dangerous goods for transport \/ UN number if applicable]<\/td>\n<\/tr>\n<\/table>\n<h3>7. Intended use and restrictions<\/h3>\n<p class=\"coa-legal\">This material is supplied as a chemical reagent and analytical reference material for in-vitro laboratory research and analytical chemistry. It is <strong>not<\/strong> a medicinal product, investigational medicinal product, dietary supplement, food, feed, novel food, cosmetic or biocide, and is <strong>not intended for human or animal consumption<\/strong> or for any in-vivo administration. It must not be used in the manufacture of any product intended for human or animal consumption or application. The purchaser is responsible for verifying the suitability of the material for the intended application and for compliance with all applicable national and Union legislation.<\/p>\n<h3>8. Declaration and release<\/h3>\n<p class=\"coa-legal\">The batch identified in section 2 was analysed by the methods stated in section 3 and the results reported are those obtained. The batch <span class=\"fill\">[conforms \/ does not conform]<\/span> to the specification set out above.<\/p>\n<div class=\"coa-sign\">\n<div>\n<div class=\"line\"><\/div>\n<p><small>Analysed by &mdash; name, position, date<\/small><\/div>\n<div>\n<div class=\"line\"><\/div>\n<p><small>Reviewed by &mdash; name, position, date<\/small><\/div>\n<div>\n<div class=\"line\"><\/div>\n<p><small>Released by (authorised person) &mdash; name, position, date<\/small><\/div>\n<\/div>\n<p class=\"coa-legal\" style=\"margin-top:1.4em\">This certificate relates solely to the batch identified above. Reproduction is permitted only in full. Electronic issue without signature is valid only where accompanied by a verifiable document reference.<\/p>\n<\/div>\n<h2>How to read a Certificate of Analysis critically<\/h2>\n<p>Four checks separate a certificate that means something from one that is a printed assertion. They apply to any supplier, including us.<\/p>\n<ul>\n<li><strong>Is the assay method named and validated?<\/strong> &#8220;HPLC 99%&#8221; without a stated method, detection wavelength and normalisation basis is a number without a procedure behind it. Area normalisation and external-standard quantification are different measurements and can give different answers on the same vial.<\/li>\n<li><strong>Is the water content reported?<\/strong> For a hygroscopic solid this is not an optional extra. An assay figure quoted on an &#8220;as-is&#8221; basis without water content cannot be converted to a dry basis, and a gravimetric calibration built on it inherits the error.<\/li>\n<li><strong>Is the batch traceable to something?<\/strong> A purity claim is a comparison. If the certificate does not say what it was compared against, the comparison cannot be reproduced.<\/li>\n<li><strong>Does anyone sign it?<\/strong> A release signature attaches a named person to the result. Certificates issued with no releasing signatory transfer the entire risk of the number to the buyer.<\/li>\n<\/ul>\n<div class=\"coa-note\">\n<p><strong>Requesting a certificate before you order.<\/strong> A blank specimen and, where available, a redacted certificate from a recent batch can be provided on request, so your quality unit can review the format against its incoming-goods procedure before committing to a purchase. Ask for the batch-specific document at the point of order; the certificate shipped with the goods is the one that counts.<\/p>\n<\/div>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>Blank specimen showing the layout, parameters, methods and reference framework used on our batch Certificates of Analysis. Contains no measured values.<\/p>","protected":false},"author":0,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"footnotes":""},"class_list":["post-11495","page","type-page","status-publish","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.9 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Certificate of Analysis \u2014 specimen template | Nonsensia<\/title>\n<meta name=\"description\" content=\"Blank specimen Certificate of Analysis: parameters, methods, CLP classification and the ISO\/ICH framework behind them. 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