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Raw Material Testing

Raw Material testing for pharmaceuticals and biologics

Our team can develop the necessary assays and methods to assess everything from active pharmaceutical ingredients (APIs) to solvents, buffers, and packaging materials, to more complex inputs for cell and gene therapies, such as cell lines or viral vectors.

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Raw material testing services include

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Identity and Purity/Potency Testing

SK pharmteco has extensive experience across a variety of raw materials, including solvents, buffers, cell culture media, packaging, and filtration consumables. We also have expertise in testing excipients for confirmation of identity, purity, and potency using in-house methods as well as USP and EP monographs.

Elemental impurities testing and analysis

SK pharmteco leverages years of sample digestion and preparation experience to develop and validate robust elemental impurity methods. We maintain a dedicated elemental impurities laboratory to ensure the most reliable results, routinely testing and releasing products in compliance with USP <232>, <233>, and ICH Q3D regulations for elemental impurity control in a CGMP laboratory.

Extractables and leachables testing

An important area of concern for drugmakers, extractables and leachables (E&L) can enter the product through manufacturing (particularly single-use technologies), packaging, or even delivery devices, such as syringes. To safeguard against E&L, we analyze solvent use, packaging, and delivery systems in CGMP and FDA-compliant laboratories.

Integrated Analytical Services

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Respected Laboratories

The range of testing requirements, procedures, and record-keeping associated with raw material testing can be daunting. That’s why it’s crucial to have an experienced, reputable, and thorough laboratory available to ensure that each starting material is released in accordance with regulations.

Multiple Modalities

SK pharmteco has analytical teams to support many modalities, from small molecules to plasmid DNA, vaccines, and cell and gene therapies. Our history and experience in all these domains allow us to tailor our raw material testing services to your needs, while staying current with the latest guidelines.

Agile Partnerships

We work with pharma and biopharma companies big and small, who range from fully virtual to almost fully in-house, outsourcing just a few specialized tests. We understand every project has unique (and sometimes evolving) requirements. Our agile partnerships reflect that need for customization.

Interested in a quote for pharmaceutical and biopharmaceutical raw material testing services?

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Raw Material Identification & Characterization with SK pharmteco

Our core assays and methods for raw material testing include:

  • Material identification: Leveraging various spectrometry and chromatography techniques, our analytical scientists can review different raw materials to confirm identity, quality, and quantity or concentration of key substances.
  • Physical properties testing: Using techniques such as Karl Fischer titration (coulometric and volumetric), differential scanning calorimetry (DSC), and thermogravimetric analysis (TGA), SK pharmteco can characterize raw material appearance/description, density, refractive index, pH, water content, conductivity, optical rotation, osmolality, particle size distribution (wet and dry), total organic carbon (TOC), and conduct various compendial tests –– based on your specific project needs.
  • Pharmacopeia testing: Our team can qualify and implement monographs and testing chapters from the various pharmacopeias and their standards, including European, British, Japanese, and United States Pharmacopoeia (USP).

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