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Analytical Reference Materials for Pharmaceutical QC

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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Pharmaceutical Primary Standards

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:

  1. USP Reference Standards with compendial application to United States Pharmacopeia National Formulary (USP-NF) specifications for active pharmaceutical ingredients (APIs), impurities, excipients, dietary supplements and related compounds.
  2. EP Reference Standards from the European Directorate for the Quality of Medicines & HealthCare (EDQM) that help lay down drug safety/purity standards in the European Pharmacopeia.
  3. BP Reference Standards with applicability to UK pharmaceutical substances and medicinal products in accordance with methods in the British Pharmacopeia.

Pharmaceutical Secondary Standards

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:

  1. Dual traceability: traceability to current batches from USP, EP and BP, as available. Metrological traceability to SI units.
  2. Certified values: certified values are typically assigned by mass balance or qNMR methods.
  3. Comprehensive certificate: detailed documentation of characterization and traceability.
  4. Robust quality: certified in ISO/IEC 17025 accredited testing laboratories and produced under the scope of ISO 17034.

Impurity Standards & Impurity Mixture Solutions

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

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 Impurity Standards

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.

Microbiological Standards

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 Standards

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.

Phytochemical Standards

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.

Related Webinars

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Top Tips You Need to Know About Pharma QC Testing & Applications

Watch the webinar for insights on System Suitability Testing, Impurity Testing and the Importance of Reference Materials in Pharma QC.

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