Dissolution testing provides crucial in-vitro drug release information that is routinely used for quality-control (QC) and quality-assurance (QA) purposes in the pharmaceutical industry. The quality-by-design (QbD) approach places strong emphasis on the role of dissolution testing in optimization of a formulation’s drug release rate and evaluation of critical process parameters (CPPs) in the manufacturing process that may affect performance of the dosage form. Data from dissolution studies form an essential component in regulatory submissions and all stages of the approval process. Post approval, the dissolution test provides continual assurance of batch-to-batch consistency in product performance as well as the ability to reject sub-performing batches. Additionally, scale-up and post-approval changes (SUPAC) guidance relies heavily on dissolution testing to assure that these routine post-approval activities do not impact product performance. Dissolution Analysis measures a drug's rate of release from its dosage form. Dissolution Analysis is routinely performed to provided critical drug release information for drug development and quality control purposes. It is also used in stability studies to determine effects of time, temperature, and humidity on a drug sample, as well as in comparator studies. Understanding of USP method <711> with dissolution apparatuses I, II, III, IV, V, and VII enable laboratories to deliver strong and reliable results for human bioequivalence studies as stated by the Food and Drug Administration (FDA). Well-equipped laboratory offers comprehensive testing services according to the pharmacopoeia (e.g. USP) and to client’s specifications. Various Dissolution Apparatus Services Offered: USP Dissolution Apparatus I – Basket, USP Dissolution Apparatus II – Paddle, USP Dissolution Apparatus III – Reciprocating Cylinder, USP Dissolution Apparatus IV – Flow-Through Cell, USP Dissolution Apparatus V – Paddle over Disk, USP Dissolution Apparatus VII - Reciprocating Holder Apparatus. Method Development & Validation of Dissolution Methods Developing the techniques and the steps of an analysis, or verifying client’s current methods can also be performed. Method Development projects can be custom-designed to meet client’s specific analytical requirements, or they can choose to use the methods developed according to laboratories proven methods. All methods are validated in compliance with USP and ICH guidelines, using client protocol, or customized protocols.

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Quinta is an established provider of multiple R&D and regulatory services for pharmaceutical, biotechnology and generic drug industries. Quinta holds GMP, GLP and GCP certificates.

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AMRI's industry-leading scientists conduct preclinical and clinical stability studies on drug substance and drug products through our full-service solid state and chromatography/dissolution groups.

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At Quotient Sciences, we pride ourselves on providing the best analytical support, delivering candidate screening, drug product analysis and phase-appropriate method development and validation.

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We have a R&D team working continuously on the development of formulas and pharmaceutical technologies. By combining new synthetic and natural substances with high-tech research equipment and new drug delivery systems, we offer differentiated products.

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Quinta is an established provider of multiple R&D and regulatory services for pharmaceutical, biotechnology and generic drug industries. Quinta holds GMP, GLP and GCP certificates.

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With a nationwide network of 29 environmental laboratories, 3 life sciences labs, 2 LabOps locations, and 46 service centers, Pace Analytical offers compendia (USP, EP, JP) methods of analytical services for qualitative and quantitative assessment of raw materials, APIs and Finished Products.

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The Mithra CDMO open platform is accessible to partners willing to leverage our technological know-how and capabilities across the drug life-cycle from proof of concept to commercialization.

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R.D. Laboratories performs dissolution on a wide range of finished dosage forms, although our customers most frequently request us to analyze tablets and capsules. We commonly use Apparatus 1 (Basket) and Apparatus 2 (Paddle).

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Sequent's standard tests include, but not limited to Colorimetry, Potentiometry, Titrations and Gravimetry.

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Our scientists at WellSpring have years of experience using advanced analytical equipment to ensure precision during all our testing procedures. Our facility is fully equipped with modern chemistry and microbiology laboratories that operate beyond cGMP standards.

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Our integrated product development services help biopharmaceutical companies shorten time to market, manage risk and access new global markets to maximize portfolio value.

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Acceleration Laboratory Services is the foremost Contract Solutions Provider for the pharmaceutical research. The ultimate goal for our associates is to deliver superior solutions to our clients, on time, and on point, while maintaining a fun and empowering work environment.

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Our laboratories, equipped with the most modern instrumentation is operated by a well trained and highly motivated staff with an average of over 10 years of practical experience. The Pharmaceutical Analytical Laboratory is GMP inspected and under control of the respective authorities.

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We offer full service solutions and project management for cost effective product development in pharmaceutical as well as food /nutraceutical areas.

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Our testing services are performed using USP/EP guidelines in compliance with FDA and DEA guidelines. Our laboratory is continually updated with new equipment to adapt to changing regulations and the ongoing needs of our clients.

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UPM’s analytical group has a diverse background in analytical method development and in-depth understanding of all facets of the drug development process.

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Our laboratories, equipped with the most modern instrumentation is operated by a well trained and highly motivated staff with an average of over 10 years of practical experience. The Pharmaceutical Analytical Laboratory is GMP inspected and under control of the respective authorities.

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Our pharmaceutical testing laboratory has been performing third-party testing of pharmaceutical finished products since the year 1990. We offer a complete package of pharmaceutical testing services for finished products for both the domestic as well as export markets.

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Our laboratories, equipped with the most modern instrumentation including UPLC, HPLC, LCMS, LC-MS/MS, LC-TOF-HRMS, GC, GC-MS and dissolution systems is operated by a well trained and highly motivated staff with an average of over 10 years of practical experience.

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The team at Arbro undertakes the development of analytical methods using HPLC, GC, AAS, HPTLC, ICP-MS, GCMS, LCMSMS, chemical and microbiological and many other techniques. All methods developed by our lab are fully validated as per the current requirements laid down in the ICH guidelines Q2(R1).

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Neopharm has two distinct validation departments; chemistry and microbiology. Each validation department is dedicated to development, validation, verification, recovery and inter-laboratory transfer of analytical methods.

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Our teams experience in developing methods for highly complex and unstable drug products compliments our formulation capabilities. PSR’s analytical services include: Assay, Purity and Dissolution Testing.

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From early strategic investigative work on possible formulations to the development and implementation of methods and the generation of regulatory submission data, our team of experienced scientists will work – and communicate – with you at every step.

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Pharmavize operates an audited 1,600-m2 GMP facility serving clients from all over the world. We are thoroughly familiar with the European and American regulatory frameworks and guarantee compliance with all applicable guidelines and directives.

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GRAM Laboratories offers development of a clinically relevant and more stable formulation. This is made possible because of the knowledge gained from preformulation evaluation. Formulation studies are customized to achieve the most appropriate formulation in a timely and cost efficient manner.