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Batch/Lot Testing for Release

Batch and lot testing for release are critical steps in ensuring the quality and consistency of pharmaceutical tablets. Natoli Scientific provides comprehensive batch testing services that align with stringent industry standards and regulatory requirements. Each lot undergoes a rigorous analysis to verify that it meets predefined specifications for weight, tablet breaking force, thickness, diameter, and dissolution, among other critical quality attributes. The testing process is meticulously designed to screen for any variation that could impact the efficacy or safety of the final product.

Utilizing state-of-the-art analytical equipment and methodologies, our experts ensure that each batch released by our clients is of the highest quality, providing end-users with the assurance that the medications they rely on are both safe and effective. This level of attention to detail fosters trust and reliability in pharmaceutical products processed through Natoli Scientific’s advanced batch and lot testing services.

Tablet Breaking Force Testing

The integrity of a tablet is critical for its efficacy and patient safety, which is where the Tablet Breaking Force testing services at Natoli Scientific come into play. Utilizing high-precision instruments, we conduct comprehensive tablet breaking force (also known as hardness) tests. A tablet must be hard enough to withstand handling and transportation yet disintegrate properly upon administration.

Our services provide rigorous assessments that measure the force required to fracture a tablet, ensuring that this delicate balance is achieved. Data obtained from our testing helps clients make informed decisions regarding the compression parameters and the formulation of the tablet, which directly impacts its breaking force. With this testing, we ensure that the tablets produced not only comply with the industry’s rigorous standards but also uphold the highest quality for consumer safety and therapeutic efficacy.

Tablet Friability Testing

Friability is a critical quality attribute for tablets, referring to the tablet’s ability to resist abrasion and crumble under stress. Natoli Scientific’s Tablet Friability Testing Services are designed to assess the durability of tablets during handling, packaging, and transport. By subjecting the tablets to the precise rotations in a friabilator, we can accurately determine the rate of abrasion or breakdown caused by mechanical action. Our detailed testing protocol ensures that each tablet batch adheres to the pharmacopeial standards, with friability values well within the acceptable range (Per USP <1216>, maximum weight loss of no more than 1.0% is acceptable for most tablets).

Tablets that pass this test are likely to maintain their integrity until the point of use, which is crucial for maintaining dosage accuracy and drug efficacy. This service underscores our commitment to providing comprehensive analyses that support the development of robust, high-quality pharmaceutical tablets.

Tablet Disintegration Testing

Disintegration is a fundamental parameter measured to assess how quickly and efficiently a tablet dissolves in the body, an indicator that is crucial for the tablet’s efficacy. Natoli Scientific’s Tablet Disintegration Testing Services employ advanced methodologies to evaluate how a tablet breaks down in specific conditions that mimic the human gastrointestinal environment. Our state-of-the-art disintegration testers rigorously monitor the time it takes for a tablet to disintegrate into particles small enough to pass through a specified mesh size, as per USP guidelines.

This test is vital as it ensures that the tablet’s active pharmaceutical ingredients are released timely and reliably within the body. The results can inform necessary adjustments in formulations or manufacturing processes, ensuring that each tablet batch consistently meets the therapeutic requirements and highest standards of quality.

Tablet Dissolution Testing

Agilent HPLC

High-Performance Liquid Chromatography (HPLC), specifically the Agilent HPLC, is an essential tool in the analytical arsenal of Natoli Scientific. During tablet dissolution testing, the Agilent HPLC is utilized for its precision in separating, identifying, and quantifying the active pharmaceutical ingredients (APIs) in the dissolution medium. After simulating the dissolution process, samples of the medium are analyzed by the HPLC system.

Here, the Agilent HPLC shines with its ability to deliver accurate and repeatable results, which are critical for determining the rate at which the tablet’s API is released. This detailed analysis is crucial for ensuring the tablet’s adherence to required dissolution specifications, as it affects the drug’s bioavailability and therapeutic effectiveness. Natoli Scientific relies on the sound science of the Agilent HPLC to provide clients with robust data, thereby facilitating informed decisions on formulation and quality assurance for their pharmaceutical products.

For more information about our Batch/Lot Testing, Quality Control, and onsite R&D lab services, visit our website or call us at 636-926-8900 today.

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Call us +1 636-926-8900