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Dissolution

Analytical >> Analytical Testing Services >> Dissolution, Dissolution

Cebiphar offers its expertise and technical platform to the pharmaceutical industry. At Cebiphar we provide physicochemical, pharmacotechnical & microbiological testings according to GMP quality standards.

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Stability, Solubility, Dissolution

Analytical >> Analytical Testing Services >> Dissolution

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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15 Dissolution Offline - VanKel, Agilent, Sotax Esters

Analytical >> Analytical Testing Services >> Dissolution, Dissolution

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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Finished Product Dissolution Testing

Analytical >> Analytical Testing Services >> Dissolution

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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2 Dissolution Online - 2 Hanson Testers with 2 HPLC

Analytical >> Analytical Testing Services >> Dissolution, Dissolution

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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Drug Dissolution & Diffusion Studies

Analytical >> Analytical Testing Services >> Dissolution

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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Drug Release & Dissolution

Analytical >> Analytical Testing Services >> Dissolution

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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Dissolution On A Wide Range of Finished Dosage Forms

Analytical >> Analytical Testing Services >> Dissolution

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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Dissolution Apparatus

Analytical >> Analytical Testing Services >> Dissolution

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

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Dissolution Apparatus Type 1 & 2

Analytical >> Analytical Testing Services >> Dissolution

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.

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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