Content Uniformity
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Content Uniformity
Most drug substances are potent molecules with efficacy at the right concentration but are either ineffective at low concentrations or toxic at high concentrations. Uniformity of the amount of active ingredient in a dosage unit such as a tablet, capsule, vial, bottle, or a drop of liquid administered is critical for patient safety and compliance. At Vici, we understand uniformity of dosage units – also known as content uniformity – from a wholistic perspective incorporating principles of formulation, manufacturing, regulatory, and analytical testing. Working with us for testing will not only get you accurate and reliable data, but will also allow you access to industry-leading scientists who can help overcome content uniformity related obstacles.
Content uniformity of in-process material, such as blend uniformity of powders or liquid suspensions, and uniformity of the final dosage form is a complex field. Having reliable testing data is critical during drug development, manufacturing of clinical trial material, and during commercial manufacturing of pharmaceutical products.
At Vici, we perform R&D content uniformity to aid development or manufacturing process scale-up and tech transfer or cGMP content uniformity testing of commercial product or to assist FDA filing. We have performed content uniformity testing on a variety of diverse dosage forms including low-dose tablets, suspensions, capsules, immediate-release tablets, suspension formulations, topical gels and creams, and injectable products. We offer HPLC-based content uniformity testing as either a stand-alone service or as part of a broader drug development offering.
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