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    Pharma Services Category of Cebiphar

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    HTL Biotechnology is the world leader in the responsible development and production of pharmaceutical-grade biopolymers.
    Polpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.
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    01 Analytical Method Development (2)

    02 Analytical Testing Services (21)

    03 Stability Studies (3)

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    01 Cebiphar (26)

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    01 France (26)

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    Cebiphar

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    PHOTOSTABILITY STUDIES

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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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    Pharma Service: Analytical

    Category: Stability Studies

    Sub Category: Photostability
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    STRESS TESTING STUDIES

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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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    Pharma Service: Analytical

    Category: Stability Studies

    Sub Category: Overview
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    SPECTROPHOTOMETRY

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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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    Pharma Service: Analytical

    Category: Analytical Testing Services

    Sub Category: UV Spectrophotometry
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    RESIDUAL SOLVENTS - GC-MS HEAD SPACE

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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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    Pharma Service: Analytical

    Category: Analytical Testing Services

    Sub Category: Mass Spectrometry and GC / MS
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    ANALYTICAL TESTING SERVICES / OVERVIEW

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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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    Pharma Service: Analytical

    Category: Analytical Testing Services

    Sub Category: Overview
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    OSMOMETER - MEASURING OSMOTIC STRENGTH OF A SOLUTION

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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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    Pharma Service: Analytical

    Category: Analytical Testing Services

    Sub Category: Osmotic Strength / Osmometer
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    BIOCIDES

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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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    Pharma Service: Analytical

    Category: Analytical Testing Services

    Sub Category: Microbiology
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    BACTERIAL & FUNGAL IDENTIFICATION

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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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    Pharma Service: Analytical

    Category: Analytical Testing Services

    Sub Category: Microbiology
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    EFFICACY OF ANTI-MICROBIOBIAL PRESERVATION

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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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    Pharma Service: Analytical

    Category: Analytical Testing Services

    Sub Category: Microbiology
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    MICROBIOLOGICAL QUALITY OF NON-STERILE PRODUCTS

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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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    Pharma Service: Analytical

    Category: Analytical Testing Services

    Sub Category: Microbiology
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    MICROBIOLOGICAL QUALITY OF STERILE PRODUCTS

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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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    Pharma Service: Analytical

    Category: Analytical Testing Services

    Sub Category: Microbiology
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    MICROBIOLOGICAL ASSAYS OF ANTIBIOTICS

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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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    Pharma Service: Analytical

    Category: Analytical Testing Services

    Sub Category: Microbiology
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    LC-MS (QDA WATERS)

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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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    Pharma Service: Analytical

    Category: Analytical Testing Services

    Sub Category: LC - MS - MS
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    GC-MS

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

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    Pharma Service: Analytical

    Category: Analytical Testing Services

    Sub Category: Mass Spectrometry and GC / MS
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    WATER CONTENT- KARL FISHER & COULOMETER

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

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    Pharma Service: Analytical

    Category: Analytical Testing Services

    Sub Category: Karl Fischer / Water Analysis
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    HARDNESS TESTING

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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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    Pharma Service: Analytical

    Category: Analytical Testing Services

    Sub Category: Hardness
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    DISSOLUTION

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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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    Pharma Service: Analytical

    Category: Analytical Testing Services

    Sub Category: Dissolution
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    DISINTEGRATION

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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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    Pharma Service: Analytical

    Category: Analytical Testing Services

    Sub Category: Disintegration
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    COMPLETE PHARMACOPEIAL / COMPENDIAL TESTING

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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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    Pharma Service: Analytical

    Category: Analytical Testing Services

    Sub Category: Complete Pharmacopoeial / Compendial Testing
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    ANALYTICAL TESTING SERVICES / CHROMATOGRAPHY

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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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    Pharma Service: Analytical

    Category: Analytical Testing Services

    Sub Category: Chromatography (TLC / LC / HPLC / UPLC / GC)
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    BATCH RESLEASE & STABILITY LOT TESTING

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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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    Pharma Service: Analytical

    Category: Analytical Testing Services

    Sub Category: Batch Release and Stability Lot Testing
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    ANALYTICAL TESTING SERVICES / ADHESIVE STRENGTH

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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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    Pharma Service: Analytical

    Category: Analytical Testing Services

    Sub Category: Adhesive Strength
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    ANALYTICAL METHOD DEVELOPMENT / OVERVIEW

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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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    Pharma Service: Analytical

    Category: Analytical Method Development

    Sub Category: Overview
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    ANALYTICAL METHOD DEVELOPMENT & VALIDATION

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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.

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    Pharma Service: Analytical

    Category: Analytical Method Development

    Sub Category: Method Development and Validation
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    STABILITY STUDIES

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    CEBIPHAR provides its support from the study design up to analyses: protocol design and optimization, sophisticated ICH storage platform regulatory compliance, multi-disciplinary teams: physico-chemical, pharmaco-technical, and microbiological analyses.

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    Pharma Service: Analytical

    Category: Stability Studies

    Sub Category: Overview
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    CLEANING VALIDATION

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    Within TERANGA Group, ACM Pharma, Cebiphar and UPS Consultants teams combine their analytical & microbiological and regulatory expertise to consult and assist in cleaning validation strategy and its implementation.

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    Pharma Service: Analytical

    Category: Analytical Testing Services

    Sub Category: Chromatography (TLC / LC / HPLC / UPLC / GC)
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