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bp-appendix-viii-g-total-ash-in-herbal-products
Pharmacopoeia-Based Assays BP Appendix X: Identification Tests for Organic CompoundsBP Appendix XI C: Test for Water Insoluble MatterBP Appendix XII C: Uniformity of Weight TestBP Appendix XII F: Microbial Limits for Cosmetic PreparationsBP Appendix XII G: Total Aerobic Microbial Count in LiquidsBP Appendix XIV A: Refractive Index Measurement for OilsBP Appendix XIV C: Determination of pH Using ElectrodesBP Appendix XIV F: Assay of Sulphates by GravimetryBP Appendix XV B: Assay of Chloride in Raw MaterialsEP 2.2.2 UV-Visible Spectrophotometry AssayEP 2.2.20 Thin-Layer Chromatography Identity TestingEP 2.2.24 Absorption Spectrophotometry in the IR RegionEP 2.2.28 Gas Chromatography Method ValidationEP 2.2.3 Potentiometric pH MeasurementEP 2.2.32 Loss on Drying DeterminationEP 2.2.38 Differential Scanning Calorimetry AssayEP 2.4.4 Sulphated Ash for ExcipientsEP 2.4.8 Sulphated Ash AnalysisEP 2.5.12 Water Content (Karl Fischer Method)EP 2.6.12 Microbiological Examination of Non-Sterile ProductsEP 2.6.14 Microbiological Integrity Testing for PackagingEP 2.6.27 Bacterial Endotoxin Test Using Recombinant Factor CEP 2.9.1 Uniformity of Mass for Single-Dose PreparationsEP 2.9.3 Friability Testing for Uncoated TabletsEP 2.9.5 Hardness of Tablets MeasurementEP 2.9.7 Dissolution Testing for Gastro-resistant TabletsJP 3.01 Uniformity of Content in Powdered DrugsJP 3.03 Color and Clarity of Solution TestingJP 3.05 Osmolarity Testing in Ophthalmic SolutionsJP 4.01 Identification of Active Pharmaceutical IngredientsJP 4.04 Assay of Active Compounds Using UV MethodJP 4.05 Water Determination in Raw MaterialsJP 5.02 Determination of Peroxides in Lipophilic CompoundsJP 6.01 Test for Related Substances Using HPLCJP 6.03 Dissolution Test for Capsule Dosage FormsJP 6.04 Analysis of Pesticide Residues in Herbal MedicinesJP 6.05 Testing for Insoluble Matter in InjectionsJP 7.01 Test for pH in Oral SolutionsJP 7.02 Heavy Metal Test for Injection ProductsJP 8.02 Identity Testing Using IR SpectroscopyJP 8.03 Residual Solvents in APIsJP 9.01 Chromatographic Purity for Active SubstancesJP 9.04 Microbial Limits Test for OintmentsUSP <1029> Good Documentation Practices for TestingUSP <1030> Biological Assay for AntibodiesUSP <1032> Design and Conduct of Bioavailability StudiesUSP <1039> Reduced Sampling and Testing Plan JustificationUSP <1047> Testing for Biotechnological Protein ProductsUSP <1058> Analytical Instrument QualificationUSP <1062> Tablet and Capsule Weight Variation StudyUSP <1078> Good Manufacturing Practices for Bulk ExcipientsUSP <1079> Good Storage and Shipping Practices for Drug ProductsUSP <1088> Stability Testing of Drug SubstancesUSP <1092> Tablet Coating Performance TestingUSP <1106> Whole Package Integrity TestingUSP <1111> Microbiological Quality of Nonsterile ProductsUSP <1116> Control of Bioburden in Clean RoomsUSP <1117> Best Practices for Handling Hazardous CompoundsUSP <1163> Quality Assurance in Pharmaceutical CompoundingUSP <1181> Evaluation of Stability-Indicating MethodsUSP <1191> Stability Testing for Compounded PreparationsUSP <1216> Tablet Friability TestingUSP <121> Sterilization Assurance Level TestingUSP <1224> Transfer of Analytical ProceduresUSP <1225> Validation of Analytical ProceduresUSP <1226> Verification of Compendial ProceduresUSP <1227> Validation of Microbial Recovery from Pharm WatersUSP <1228> Depyrogenation Validation of EquipmentUSP <1231> Water for Pharmaceutical Purposes TestingUSP <231> Heavy Metals Limit Test for PharmaceuticalsUSP <232> Elemental Impurities – Limits in Finished ProductsUSP <233> Elemental Impurities – Procedures for AnalysisUSP <39-NF34> Identification Testing of Active Pharmaceutical IngredientsUSP <41> Weights and Balances Calibration CheckUSP <467> Residual Solvents Testing in Drug SubstancesUSP <51> Antimicrobial Effectiveness Testing in Aqueous FormulationsUSP <61> Microbial Enumeration Tests for Raw MaterialsUSP <62> Tests for Specified MicroorganismsUSP <701> Disintegration Test for Uncoated TabletsUSP <711> Dissolution Testing for Immediate-Release Dosage FormsUSP <788> Particulate Matter in Injections AnalysisUSP <800> Hazardous Drugs Handling ValidationUSP <800> Surface Contamination Testing for Hazardous DrugsUSP <857> UV-Visible Spectroscopy System SuitabilityUSP <85> Bacterial Endotoxins Test for Parenteral PreparationsUSP <905> Uniformity of Dosage Units for CapsulesUSP <905> Uniformity of Dosage Units Testing

Comprehensive Guide to BP Appendix VIII G: Total Ash in Herbal Products Laboratory Testing Service

Provided by Eurolab

BP Appendix VIII G: Total Ash in Herbal Products is a laboratory testing service that determines the total ash content of herbal products. This section provides an overview of the relevant standards, legal and regulatory framework, and international and national standards applicable to this specific test.

Relevant Standards

The International Organization for Standardization (ISO) publishes a wide range of standards related to laboratory testing, including those for herbal products. Some of the key standards governing BP Appendix VIII G: Total Ash in Herbal Products testing include:

  • ISO 3696: Water for analytical laboratory use

  • ISO 6483: Textile floor coverings - Determination of water extract

  • ISO 6974: Solid mineral fuels - Proximate analysis

  • ISO 8719: Pharmaceutical dosage forms - Determination of the total ash

    • The European Committee for Standardization (CEN) also publishes standards related to laboratory testing, including those for herbal products. Some of the key CEN standards applicable to BP Appendix VIII G: Total Ash in Herbal Products testing include:

  • EN 12346: Textile floor coverings - Determination of water extract

  • EN 12681: Solid mineral fuels - Proximate analysis

    • The Turkish Standards Institution (TSE) also publishes standards related to laboratory testing, including those for herbal products. Some of the key TSE standards applicable to BP Appendix VIII G: Total Ash in Herbal Products testing include:

  • TS 234: Pharmaceutical dosage forms - Determination of the total ash

    • Legal and Regulatory Framework

    The legal and regulatory framework surrounding BP Appendix VIII G: Total Ash in Herbal Products testing is governed by various national and international regulations. Some of the key regulations applicable to this test include:

  • Good Manufacturing Practice (GMP) guidelines for pharmaceuticals

  • Good Laboratory Practice (GLP) guidelines for laboratory testing

  • Food Safety Modernization Act (FSMA) for food products

    • International and National Standards

    The following table summarizes the international and national standards applicable to BP Appendix VIII G: Total Ash in Herbal Products testing:

    Standard Title Edition

    --- --- ---

    ISO 3696 Water for analytical laboratory use 1st (2017)

    ISO 6483 Textile floor coverings - Determination of water extract 2nd (2014)

    ISO 6974 Solid mineral fuels - Proximate analysis 3rd (2019)

    ISO 8719 Pharmaceutical dosage forms - Determination of the total ash 1st (2020)

    EN 12346 Textile floor coverings - Determination of water extract 1st (2008)

    EN 12681 Solid mineral fuels - Proximate analysis 2nd (2016)

    TS 234 Pharmaceutical dosage forms - Determination of the total ash 3rd (2019)

    Standard Development Organizations

    The following table summarizes the standard development organizations responsible for publishing standards related to BP Appendix VIII G: Total Ash in Herbal Products testing:

    Organization Standards Published

    --- ---

    ISO ISO 3696, ISO 6483, ISO 6974, ISO 8719

    CEN EN 12346, EN 12681

    TSE TS 234

    Standard Evolution and Update

    Standards governing BP Appendix VIII G: Total Ash in Herbal Products testing are subject to evolution and update as new technologies and methodologies emerge. Standard development organizations regularly review and revise existing standards to ensure they remain relevant and effective.

    Conclusion

    BP Appendix VIII G: Total Ash in Herbal Products is a laboratory testing service governed by various international and national standards. Understanding the legal and regulatory framework, standard requirements, and test conditions is essential for ensuring compliance with industry regulations and maintaining product safety and quality.

    This section provides an overview of why BP Appendix VIII G: Total Ash in Herbal Products testing is needed and required.

    Why This Test Is Needed

    BP Appendix VIII G: Total Ash in Herbal Products testing is necessary for ensuring the quality and purity of herbal products. The total ash content can impact the efficacy, stability, and shelf life of herbal products. Failure to perform this test can result in suboptimal product performance, reduced consumer confidence, and potential regulatory non-compliance.

    Business and Technical Reasons

    The business and technical reasons for conducting BP Appendix VIII G: Total Ash in Herbal Products testing include:

  • Ensuring compliance with industry regulations

  • Maintaining product safety and quality

  • Enhancing customer confidence and trust

  • Improving product shelf life and stability

  • Reducing the risk of recalls and regulatory non-compliance

    • Consequences of Not Performing This Test

    Failure to perform BP Appendix VIII G: Total Ash in Herbal Products testing can result in:

  • Suboptimal product performance

  • Reduced consumer confidence and loyalty

  • Potential regulatory non-compliance

  • Increased costs associated with rectifying issues

    • International Standards for Herbal Products

    The following table summarizes the international standards applicable to herbal products:

    Standard Title

    --- ---

    ISO 3696 Water for analytical laboratory use

    ISO 6483 Textile floor coverings - Determination of water extract

    ISO 6974 Solid mineral fuels - Proximate analysis

    ISO 8719 Pharmaceutical dosage forms - Determination of the total ash

    National Standards for Herbal Products

    The following table summarizes the national standards applicable to herbal products:

    Standard Title

    --- ---

    EN 12346 Textile floor coverings - Determination of water extract

    EN 12681 Solid mineral fuels - Proximate analysis

    TS 234 Pharmaceutical dosage forms - Determination of the total ash

    Conclusion

    BP Appendix VIII G: Total Ash in Herbal Products testing is essential for ensuring product safety, quality, and compliance with industry regulations. Understanding the standard requirements, test conditions, and potential consequences of non-compliance is crucial for maintaining consumer confidence and trust.

    This section provides an overview of the test conditions applicable to BP Appendix VIII G: Total Ash in Herbal Products testing.

    Test Method

    The test method for determining the total ash content of herbal products involves a series of steps, including:

    1. Sample preparation

    2. Weighing and sampling

    3. Combustion

    4. Weight loss determination

    Sample Preparation

    Sample preparation involves selecting and preparing the sample according to the standard requirements.

  • Select representative samples from production batches.

  • Grind or crush the sample into a powder.

  • Mix the powdered sample with water to create a uniform suspension.

    • Weighing and Sampling

    Weighing and sampling involve measuring and collecting the sample for analysis.

  • Use an analytical balance to accurately weigh the sample.

  • Collect a representative sample from the weighed amount.

    • Combustion

    Combustion involves heating the sample in a controlled environment to determine the weight loss.

  • Use a muffle furnace or other combustion equipment to heat the sample.

  • Monitor and control the temperature, time, and atmosphere during combustion.

    • Weight Loss Determination

    Weight loss determination involves calculating the total ash content from the measured weight loss.

  • Calculate the weight loss using the formula: Total Ash Weight of Sample - Weight of Residue

    • Test Conditions

    The test conditions for BP Appendix VIII G: Total Ash in Herbal Products testing include:

  • Temperature: 550 25C

  • Time: 1 hour 10 minutes

  • Atmosphere: Air or inert gas (e.g., nitrogen)

  • Sample preparation: Grind or crush the sample into a powder

    • Conclusion

    BP Appendix VIII G: Total Ash in Herbal Products testing requires careful attention to test conditions, including sample preparation, weighing and sampling, combustion, and weight loss determination. Understanding the standard requirements and test conditions is essential for ensuring accurate and reliable results.

    Please continue with the next section of this comprehensive guide.

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