Reference materials are a critical component of the analytical testing workflow. These standards help guarantee the safety and efficacy of drug materials. Reference materials are your most reliable option for instrument calibration, method development and quality control checks.
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, partner with us for high-quality analytical tools.
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Whether you’re calibrating your measurement system or validating a method, bolster confidence in your analytical results with the use of primary reference standards from pharmacopeias and National Metrology Institutes (NMIs).
The Supelco® range of pharmaceutical secondary standards provide pharmaceutical laboratories and manufacturers with a convenient and cost effective alternative to making in-house working standards.
In the last two decades, the perception on herbal medicinal products has changed, and it is agreed that herbal medicinal products do, in fact, need effective quality control in order to ensure that the products are safe and meet established quality standards.
Extractables and Leachables (E&L) are chemical compounds with the potential to migrate into pharmaceutical or clinical products from packaging materials, tubings or medical devices.
Reference materials, standards and certified reference materials are critical for analytical testing. We can help you to choose the ideal reference material for your application, whether you are using reference materials for calibration or quantitative analysis.
Convenient and cost-effective alternative to primary reference standards, with traceability to USP, BP, EP standards; manufactured to ISO/IEC 17025 and ISO Guide 34.
From time to time, the Compendial Lots that these Secondary Standards are made traceable to change.
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This special edition of Analytix Reporter lists application notes for Small and Large Molecule Analysis and QC.
Find our workflow solutions for Small Molecule and Biologics analysis.
Established by reputed pharmacopeia organizations such as United States Pharmacopeia (USP), European Pharmacopeia (EP or Ph. Eur.) and British Pharmacopeia (BP), primary pharmaceutical reference standards help ensure highest quality in pharmaceutical development and manufacturing. These reference materials are accepted globally without comparison to other standards. Also called Compendial Standards, primary standards are designed for use in compendial (monograph) methods specified in the corresponding pharmacopeias.
We enable convenient shopping and quick delivery of primary reference materials with the corresponding applications:
Our pre-qualified Pharmaceutical Secondary Certified Reference Materials (CRMs) are convenient and cost-effective alternatives to preparing in-house working standards. With documented traceability to Primary Reference Standards as well to SI units via mass balance and/or qNMR, Pharmaceutical Secondary CRMs eliminate the need to qualify and maintain your laboratory’s in-house standards. They are certified by an ISO/IEC 17025 accredited testing laboratory, and produced under the scope of ISO 17034.
Pharmaceutical Secondary CRMs are designed to complement Primary Reference Standards from global Pharmacopoeias within your analytical workflow. Together, Primary Reference Standards and Secondary CRMs form the foundation of your Reference Material program.
Our pharma secondary standards offer the following features and benefits:
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.
Watch the webinar for insights on System Suitability Testing, Impurity Testing and the Importance of Reference Materials in Pharma QC.
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