Pharma Services Category of Cebiphar

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Is the drug substance/product sensitive to light? Is this impact acceptable ? Are precautionary measures needed in manufacturing? Is a light resistant packaging mandatory? For all those questions, CEBIPHAR provides its support from protocol up to analyses

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Forced degradation is a degradation of new drug substance and product at conditions more severe than accelerated conditions. It is required to demonstrate specificity of stability indicating methods and also provides an insight into degradation pathways.

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Our technical platforms encompasses, among others: UV-visible spectrophotometers, infra-red spectrometer, atomic absorption spectrophotometer (SAA) flame & oven, colorimeter.

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Testing should be performed for residual solvents when production or purification processes are known to result in the presence of such solvents. Drug products should contain no higher levels of residual solvents than can be supported by safety data.

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Cebiphar offers analytical testing of raw materials, APIs, excipients and FDFs. Testing is performed in accordance with Eur Ph, USP, or client specific methods. We regularly acquire new equipment to meet new regulatory requirements and clients’ needs.

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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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The aim of biocide activity test is to determine the capacity of a product (antiseptic, disinfectant surface/hand) to cause a logarithmic reduction desired at a given time. The tests are conducted in accordance to the reference standards.

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Phenotypic identification/ Mass Spectrometry - Maldi TOF/ rDNA Bacterial and Fungal identification. Thanks to our center of expertise, you benefit from the combination of all these technologies to guarantee reliability and reactivity.

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The control of conservation of the product, while introducing a minimum of preservatives, is a real challenge. We test the formulation and verify the effectiveness of the conservation. The tests are conducted in accordance to the ref. standards in force.

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Certain germs have a pathogenic power that justifies their research & enumeration, the main ones being P. aeruginosa, S.aureus, E.coli, Salmonella, A. brasiliensis, C.albicans. The tests are carried out in accordance to the EU and Int' standards.

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Cebiphar and its sister company ACM Pharma undertake sterility testing (clean room, isolators, BacT/Alert®), Bacterial endotoxins/ LAL, Particulate contamination (subvisible particles), Container Closure Integrity Testing.

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Cebiphar is expert in microbiological testing and handles your antibiotic assays, Ph Eur, USP, specific methods. Our assets: experience of many different formulations (human & veterinary medicines, medical devices), last generation automated systems.

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Cebiphar undertakes analytical testing with various techniques, among which LC-MS (QdA Waters) for non-chromophoric molecules.

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Cebiphar undertakes analytical testing with various techniques, among which GC-MS (Head-Space).

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Cebiphar offers various techniques to assess water content: Karl Fisher and coulometer.

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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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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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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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Cebiphar offers analytical testing of raw materials, APIs, excipients and FDFs. Compendial testing (physicochemical & microbiological) is performed in accordance with Eur Ph, USP, JP. New equipment is regularly acquired to meet regulatory & clients’ needs

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Among others techniques, our sophisticated platform encompass : Liquid chromatography (HPLC/ UPLC), detection : UV, diode-array, fluorescence, refractometernThin layer chromatography, Gas chromatography (GC/ FID and GC-MS, Head space), LC-MS (QDa Waters)

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Cebiphar' services, among others, is the analysis of your samples during pre and post MA stability studies (all ICH-VICH conditions, stress testing studies, photostability studies, transport studies) and batch release testing of your FDFs.

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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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Cebiphar had a considerable experience and knowledge in method development and validation for small molecules. Our objective is to provide our clients with the most tailored solution at each stage of their projects, and to ensure regulatory compliance.

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Preparation of monographs, Development, validation and transfer of physicochemical methods, Stability indicating assay methods for active ingredients, degradation, products and preservatives, Discriminating dissolution tests, Determination of impurities.