Pharmaceutical products are manufactured by combining different materials such as the active ingredient and inactive ingredients. Each of the ingredients is evaluated prior to use in production. Depending on the type of product (tablets and capsules vs. biotech products), as few as 15-20 to as many as 60 raw materials might be needed for product development. Raw material testing is a critical step in the manufacturing process of pharmaceuticals and biologics. It helps to ensure the safety and efficacy of the final product and is required by regulatory agencies such as the FDA and EMA. And many of the common ingredients are listed in the United States Pharmacopeia (USP) and have a defined panel of tests that must be conducted depending on the material.
Raw material testing involves analyzing the quality and purity of the starting materials used to make the final drug product. The raw materials used in the production of pharmaceuticals and biologics include active pharmaceutical ingredients (APIs), excipients, solvents, and packaging materials. Each of these materials must meet strict quality standards to ensure the safety and efficacy of the final product. USP provides monographs for the most commonly used raw materials in the pharmaceutical industry. Often these monographs detail several different analytical techniques. Karl Fischer moisture analysis, pH, viscosity and titrations are common but more complex techniques such as HPLC, GC-MS and ICP-MS are sometimes required.
Raw material testing typically involves the following steps:
Identification: The raw material is identified to ensure that it is the correct material and meets the specifications for the final product.
Purity: The purity of the raw material is analyzed to ensure that it is free from impurities that could affect the quality of the final product.
Potency: The potency of the raw material is analyzed to ensure that it meets the required strength for the final product.
Microbial testing: The raw material is tested for microbial contamination to ensure that it is free from harmful microorganisms that could cause infections.
Physical testing: The physical properties of the raw material, such as particle size, density, and flowability, are analyzed to ensure that it meets the required specifications.
Stability testing: The stability of the raw material is analyzed to ensure that it remains stable over time and does not degrade or lose potency.
ALL Chemistry Inc. offers comprehensive testing services per pharmacopiea (USP, EP, BP and JP) and to your specifications. Our analytical chemistry and microbiology teams can help you with the necessary testing for raw materials, APIs, finished products, packaging materials and medical devices. Please contact us directly to discuss the testing you might require.
TESTING SERVICES FOR RAW MATERIALS
Physicochemical Properties
Identity and Purity – Small Molecules
Identity and Purity – Large Molecules
AVAILABLE SERVICES
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ICP-MS
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UV/Vis
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FTIR
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HPLC
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GC
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pH
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Viscosity
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Particle size
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IC
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Loss on drying
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Limit tests
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Heavy metals
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Residual solvents
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VOC
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Osmolality and osmolarity
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Assays and chemical tests
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Physico-chemical determinations
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Organic volatile impurities (OVI)
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Water testing for pharmaceutical purposes and controlled process environments
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Identification of active ingredients and impurities
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