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    Analytical testing is a critical part in every step of drug development and manufacturing. The qualitative and quantitative results generated from validated analytical testing provide first-hand information to control and ensure the quality and safety of raw materials, intermediates, and finished products. Like many other CMC (chemical, manufacturing and control) activities, analytical testing is also frequently outsourced. Many factors are attributed to this rapid market growth, including continuous outsourcing from pharmaceutical companies, growing pipelines for biological candidates, and increasing demand for more analytical details on drugs and process development by regulatory agencies. In response to the changing market dynamics, service providers are striving to provide analytical testing with quality, accuracy, and robustness all within tight timelines. As the contract research organizations (CROs) have become more integrated, small analytical labs need to establish their niche to succeed. Global contract analytical Laboratories provide QC laboratory analysis, method development, validation and expert advice for both finished products and raw materials for pharmaceutical and biopharmaceutical companies. Quality Compliance testing is done a wide variety of raw material and finished product forms including High Potent Active Pharmaceutical Ingredients (APIs), Raw Materials and Excipients, Powders - Capsules/Semi-solids, Oils - Oral Solutions and Syrups, Liquids, Vitamins, Minerals, and Nutritional, Natural Health Products (NHPs) – Powders, Herbals – Suspensions, Finished Pharmaceutical Products (Tablets, Capsules/Semi-solids, Oral Solutions and Syrups, Gels, Creams and Ointments, Powders, Suspensions, Transdermals etc. Blend uniformity is a function of both the formulation and mixing action. Once the formulation is optimized from a theoretical process standpoint, blend uniformity must be validated during piloting and scale-up. From a manufacturer’s perspective; poor uniformity generates unacceptable amounts of discarded products, resulting in significant loss of revenue. However, no method currently exists that detects uniformity during the blending process, and as a result the true optimum endpoint is realized rarely. CGMP (21 CFR.211.110) for testing homogeneity and uniformity requires an in-process testing of powder blends to demonstrate adequacy of mixing, but it does not state that the blend has to be directly assessed for uniformity. It was on this premise that the original draft stratified sampling guidance document allowed the use of in-process dosage unit data as a surrogate to demonstrate dosage unit uniformity during routine manufacture. Blend uniformity should be assessed during process design (Stage 1 Validation) and process qualification (Stage 2 Validation). Defaulting directly to the testing of in-process dosage units is discouraged, the exception being when blend sampling presents severe risks to the operators taking the samples (which should be discussed and accepted by regulators).

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    Arbro Pharmaceuticals Pvt. Ltd

    Cayman Chemical Company Inc

    Proveris Scientific

    Stason Pharmaceuticals, Inc.

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    INDIA

    UNITED STATES

    Cayman Chemical Company Inc

    • FDA

    Virtual BoothEurope's most reliable and versatile source for Prostaglandin APIs// FDA Inspected 2017

    UNITED STATES United States

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    IFT Annual Expo

    Participation Not Confirmed

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    Homogeneity & Stability Testing

    Supporting Information: Click here to upload a PDF
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    Contact the Supplier

    - Service Details

    Employing multiple chemical testing methods, we perform qualitative/quantitative analysis, purification, & characterization of chemical entities such as natural products, synthetic compounds, cosmetics, pharmaceuticals, & drugs of abuse from organic & biological matrices.

    - Directory Listing

    Pharma Service: Analytical

    Category: Analytical Testing Services

    Sub Category: Content Uniformity / Homogeneity

    Arbro Pharmaceuticals Pvt. Ltd

      Virtual Booth Upgrade this company profile, update & customize all content// Ask PharmaCompass, click HERE

      INDIA India

      Contact Supplier Post An Enquiry

      Virtual Booth Virtual Booth

      IFT Annual Expo

      Participation Not Confirmed

      Update your events

      Uniformity of Content & Dosage Units

      Supporting Information: Click here to upload a PDF
      Link Icon Link to Supplier Content
      Contact the Supplier

      - Service Details

      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.

      - Directory Listing

      Pharma Service: Analytical

      Category: Analytical Testing Services

      Sub Category: Content Uniformity / Homogeneity

      Proveris Scientific

        Virtual Booth Upgrade this company profile, update & customize all content// Ask PharmaCompass, click HERE

        UNITED STATES United States

        Contact Supplier Post An Enquiry

        Virtual Booth Virtual Booth

        IFT Annual Expo

        Participation Not Confirmed

        Update your events

        Nasal Spray Testing for Content Uniformity

        Supporting Information: Click here to upload a PDF
        Link Icon Link to Supplier Content
        Contact the Supplier

        - Service Details

        Proveris Scientific's Indizo system offers an automated, walk away nasal spray testing platform for dose content uniformity and shot weight tests.

        - Directory Listing

        Pharma Service: Analytical

        Category: Analytical Testing Services

        Sub Category: Content Uniformity / Homogeneity

        Stason Pharmaceuticals, Inc.

        • FDA

        Virtual Booth Upgrade this company profile, update & customize all content// Ask PharmaCompass, click HERE

        UNITED STATES United States

        Contact Supplier Post An Enquiry

        Virtual Booth Virtual Booth

        IFT Annual Expo

        Participation Not Confirmed

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        Identity, Quantitation, Potency, Content Unif...

        Supporting Information: Click here to upload a PDF
        Link Icon Link to Supplier Content
        Contact the Supplier

        - Service Details

        Analytical methods are essential to both the pharmaceutical development process and the evaluation of drug product to meet the standard of potency, purity and stability. We also have a DEA analytical permit for CII-CIV products.

        - Directory Listing

        Pharma Service: Analytical

        Category: Analytical Testing Services

        Sub Category: Content Uniformity / Homogeneity

        Analytical testing is a critical part in every step of drug development and manufacturing. The qualitative and quantitative results generated from validated analytical testing provide first-hand information to control and ensure the quality and safety of raw materials, intermediates, and finished products. Like many other CMC (chemical, manufacturing and control) activities, analytical testing is also frequently outsourced. Many factors are attributed to this rapid market growth, including continuous outsourcing from pharmaceutical companies, growing pipelines for biological candidates, and increasing demand for more analytical details on drugs and process development by regulatory agencies. In response to the changing market dynamics, service providers are striving to provide analytical testing with quality, accuracy, and robustness all within tight timelines. As the contract research organizations (CROs) have become more integrated, small analytical labs need to establish their niche to succeed. Global contract analytical Laboratories provide QC laboratory analysis, method development, validation and expert advice for both finished products and raw materials for pharmaceutical and biopharmaceutical companies. Quality Compliance testing is done a wide variety of raw material and finished product forms including High Potent Active Pharmaceutical Ingredients (APIs), Raw Materials and Excipients, Powders - Capsules/Semi-solids, Oils - Oral Solutions and Syrups, Liquids, Vitamins, Minerals, and Nutritional, Natural Health Products (NHPs) – Powders, Herbals – Suspensions, Finished Pharmaceutical Products (Tablets, Capsules/Semi-solids, Oral Solutions and Syrups, Gels, Creams and Ointments, Powders, Suspensions, Transdermals etc. Blend uniformity is a function of both the formulation and mixing action. Once the formulation is optimized from a theoretical process standpoint, blend uniformity must be validated during piloting and scale-up. From a manufacturer’s perspective; poor uniformity generates unacceptable amounts of discarded products, resulting in significant loss of revenue. However, no method currently exists that detects uniformity during the blending process, and as a result the true optimum endpoint is realized rarely. CGMP (21 CFR.211.110) for testing homogeneity and uniformity requires an in-process testing of powder blends to demonstrate adequacy of mixing, but it does not state that the blend has to be directly assessed for uniformity. It was on this premise that the original draft stratified sampling guidance document allowed the use of in-process dosage unit data as a surrogate to demonstrate dosage unit uniformity during routine manufacture. Blend uniformity should be assessed during process design (Stage 1 Validation) and process qualification (Stage 2 Validation). Defaulting directly to the testing of in-process dosage units is discouraged, the exception being when blend sampling presents severe risks to the operators taking the samples (which should be discussed and accepted by regulators).

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