Reference materials are critical for pharmaceutical manufacturers to ensure safe and effective drug material production. Reference materials are primarily employed in active pharmaceutical ingredient (APIs) quantification, elemental impurity identification, and end-product sterility determination. We offer a vast reference material portfolio to meet the needs of your analytical workflow across the drug manufacturing process.
Whether you require compendial primary standards from the most widely used, global Pharmacopeias, convenient replacements for current in-house secondary standards, or elemental impurity standards, we are your partner for high-quality analytical tools.
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Pharmaceutical primary standards are produced and supplied by scientific organizations such as the European Pharmacopoeia (EP), British Pharmacopoeia (BP), and the United States Pharmacopeia (USP). Pharmaceutical secondary standards provide pharma QC labs with convenient and cost-effective alternatives to producing and managing in-house working standards. With multi-traceability to USP and/or EP and double-accreditation under ISO/IEC 17025 and ISO 17034, our secondary standards offer extensive certification, robust traceability, and significant time-savings.
USP refers to drug impurities as ‘anything other than a drug substance or excipient in a drug product’. We provide a wide range of impurity standards and ready-to-use impurity mixture solutions for all your analytical needs.
Extractables and leachables (E&L) are chemical compounds with potential to migrate into pharmaceutical or clinical products from packaging materials, tubing, or medical devices. Pharmaceutical products and medical devices manufacturers are obliged to perform extensive E&L studies to identify compounds which may leach into the product. We offer a comprehensive portfolio of more than 200 certified reference materials and analytical standards for commonly found extractables and leachables. We have also developed certified calibration mixes for LC and GC to help streamline your analysis.
Elemental impurities in drug products may arise from intentional addition during synthesis or unintentionally. Elemental impurities pose a risk to patient health and must be controlled within acceptable limits. Our element mixes includes standard mixes of TraceCERT® certified reference materials corresponding to the oral, parenteral, and inhalation elemental concentrations limits as defined in the ICHQ3D guidelines.
Certified reference microorganisms are convenient replacements for in-house stock and working cultures. Vitroids™ and LENTICULE® Discs are highly soluble discs containing a certified number of colony forming units (CFUs). These quantitative CRMs are traceable directly to National Culture Collections (NCTC, NCPF and CECT®) and are produced under the double-accreditation of ISO/IEC 17025 and ISO 17034.
Physical properties are often measured to determine substance identity or purity. To ensure measurement accuracy, equipment should undergo regular calibration and verification using accurate analytical standards. We offer a broad spectrum of physical properties standards and CRMs from various prestigious brands, including an exclusive range of Paragon Scientific Ltd products.
Our phytochemical analytical standards include natural products ranging from alcohols and phenols, aldehydes and ketones, alkaloids, flavonoids, glucosinolates, and isoprenoids to organic acids and esters, phenylpropanes, quinones, and tannins. These reference substances are suited for LC, LC-MS/MS, IR, NMR, and other analytical applications in the testing of plant, herb, or dietary supplements. They may also be used in other applications including forensics, clinical toxicology, prescription monitoring and pharmaceutical research.