EUROLAB
ep-2220-thin-layer-chromatography-identity-testing
Pharmacopoeia-Based Assays BP Appendix VIII G: Total Ash in Herbal ProductsBP 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 2.2.24 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

EP 2.2.20 Thin-Layer Chromatography Identity Testing: Laboratory Testing Services Provided by Eurolab

EP 2.2.20 Thin-Layer Chromatography Identity Testing is a laboratory testing service provided by Eurolab, which adheres to the guidelines and requirements outlined in various international and national standards. The primary standard governing this testing service is ISO/IEC 17025:2017, General Requirements for the Competence of Testing and Calibration Laboratories.

International Standards

  • ISO/IEC 17025:2017, General Requirements for the Competence of Testing and Calibration Laboratories

  • ISO 3696:1987, Water for Analytical Laboratory Use Specification and Test Methods

  • ASTM E2601-13, Standard Practice for Thin-Layer Chromatography (TLC) Analysis

    • National Standards

  • EN ISO/IEC 17025:2018, General Requirements for the Competence of Testing and Calibration Laboratories

  • TSE EN ISO/IEC 17025:2018, General Requirements for the Competence of Testing and Calibration Laboratories

    • Standard Development Organizations

    The International Organization for Standardization (ISO) is a global standard development organization that develops and publishes international standards. The American Society for Testing and Materials (ASTM) is another prominent standard development organization that focuses on developing standards for various industries, including analytical chemistry.

    Evolution of Standards

    Standards evolve over time to reflect changes in technology, industry practices, and regulatory requirements. Eurolab ensures that its testing services are up-to-date with the latest standards and guidelines.

    Standard Numbers and Scope

  • ISO/IEC 17025:2017 General Requirements for the Competence of Testing and Calibration Laboratories

  • ISO 3696:1987 Water for Analytical Laboratory Use Specification and Test Methods

  • ASTM E2601-13 Standard Practice for Thin-Layer Chromatography (TLC) Analysis

    • Industry-Specific Standards Compliance

    Various industries require compliance with specific standards, such as:

  • Pharmaceuticals: USP <202> (Water for Pharmaceutical Purposes)

  • Food and Beverage: FDA 21 CFR 110 (Good Manufacturing Practices)

  • Cosmetics: EU Regulation 1223/2009 (Cosmetic Products)

    • Standard Compliance Requirements

    Standards compliance is essential to ensure the quality, safety, and efficacy of products. Eurolabs testing services are designed to meet the specific requirements of each industry.

    Standard-Related Information Conclusion

    Eurolabs EP 2.2.20 Thin-Layer Chromatography Identity Testing service adheres to the guidelines outlined in various international and national standards. Compliance with these standards ensures the quality, safety, and efficacy of products.

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    Thin-Layer Chromatography Identity Testing is a critical analytical technique used to identify and quantify compounds in various samples. The primary reasons for conducting this testing service are:

    1. Quality Control: Thin-Layer Chromatography Identity Testing ensures the quality of products by verifying their composition and purity.

    2. Regulatory Compliance: This testing service helps manufacturers comply with industry-specific regulations and standards.

    3. Product Safety: Thin-Layer Chromatography Identity Testing ensures that products are safe for human consumption or use.

    Business and Technical Reasons

    Thin-Layer Chromatography Identity Testing is essential in various industries, including:

  • Pharmaceuticals: Ensures the quality and purity of active pharmaceutical ingredients (APIs)

  • Food and Beverage: Verifies the identity and quantity of food additives and preservatives

  • Cosmetics: Confirms the presence and concentration of cosmetic ingredients

    • Consequences of Not Performing This Test

    Failing to conduct Thin-Layer Chromatography Identity Testing can result in:

  • Product recalls and withdrawals

  • Regulatory fines and penalties

  • Damage to brand reputation and customer trust

    • Risk Factors and Safety Implications

    Thin-Layer Chromatography Identity Testing helps mitigate risks associated with product contamination, adulteration, or mislabeling.

    Quality Assurance and Quality Control Aspects

    Eurolabs testing services are designed to meet the quality assurance and control requirements outlined in ISO/IEC 17025:2017.

    Contributions to Product Safety and Reliability

    Thin-Layer Chromatography Identity Testing ensures that products meet regulatory standards, ensuring customer safety and satisfaction.

    Competitive Advantages of Having This Test Performed

    Companies that conduct Thin-Layer Chromatography Identity Testing enjoy a competitive advantage in the market due to their commitment to quality and product safety.

    Cost-Benefit Analysis of Performing This Test

    The benefits of conducting Thin-Layer Chromatography Identity Testing far outweigh the costs, ensuring long-term savings and revenue growth.

    Standard Requirements and Needs Conclusion

    Thin-Layer Chromatography Identity Testing is a critical analytical technique that ensures product quality, regulatory compliance, and customer safety. Eurolabs testing services are designed to meet the specific requirements of each industry.

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    Thin-Layer Chromatography (TLC) Analysis: A Brief Overview

    Thin-Layer Chromatography (TLC) is an analytical technique used to separate, identify, and quantify compounds in various samples. TLC involves applying a sample mixture onto a thin layer of silica gel or alumina coated on a glass plate. The plate is then developed using a solvent system, causing the compounds to migrate based on their affinities for the stationary phase.

    TLC Applications

    TLC has various applications in analytical chemistry, including:

  • Purification: TLC can be used to separate and purify compounds from complex mixtures.

  • Identification: TLC is a useful tool for identifying unknown compounds or verifying compound identity.

  • Quantitation: TLC can be used to quantify the concentration of compounds in a sample.

    • TLC Advantages

    TLC offers several advantages, including:

  • High sensitivity: TLC can detect and quantify compounds at very low concentrations.

  • Rapid analysis: TLC is a relatively fast analytical technique compared to other methods.

  • Low cost: TLC is a cost-effective analytical method, making it suitable for routine quality control testing.

    • TLC Limitations

    While TLC has several advantages, it also has some limitations:

  • Limited resolution: TLC may not provide the same level of resolution as other analytical techniques.

  • Sample preparation: TLC requires careful sample preparation to ensure accurate results.

  • Interpretation: TLC data interpretation can be complex and require expertise.

    • TLC Conclusion

    Thin-Layer Chromatography (TLC) is a powerful analytical technique used to separate, identify, and quantify compounds in various samples. Eurolabs testing services include TLC analysis as part of its comprehensive quality control program.

    ---

    Regulatory Compliance: Ensuring Adherence to Industry-Specific Standards

    Eurolabs EP 2.2.20 Thin-Layer Chromatography Identity Testing service ensures compliance with industry-specific standards and regulations. The primary regulatory requirements for this testing service are:

  • USP <202>: Water for Pharmaceutical Purposes

  • FDA 21 CFR 110: Good Manufacturing Practices

  • EU Regulation 1223/2009: Cosmetic Products

    • Industry-Specific Regulatory Requirements

    Each industry has its unique regulatory requirements, including:

  • Pharmaceuticals: USP <202> and FDA 21 CFR 110

  • Food and Beverage: FDA 21 CFR 110 and EU Regulation 1334/2008

  • Cosmetics: EU Regulation 1223/2009

    • Regulatory Compliance Benefits

    Compliance with industry-specific standards ensures:

  • Product safety: Ensures that products meet regulatory requirements for safety.

  • Quality assurance: Verifies the quality of products and raw materials.

  • Reputation protection: Prevents damage to brand reputation due to non-compliance.

    • Regulatory Compliance Challenges

    Compliance with industry-specific standards can be challenging due to:

  • Complexity: Regulatory requirements can be complex and difficult to interpret.

  • Constant changes: Regulatory requirements evolve over time, requiring continuous updates.

  • Resources: Compliance may require significant resources, including personnel and equipment.

    • Regulatory Compliance Conclusion

    Eurolabs EP 2.2.20 Thin-Layer Chromatography Identity Testing service ensures compliance with industry-specific standards and regulations. By adhering to these requirements, companies can ensure product safety, quality assurance, and reputation protection.

    ---

    Water Quality: Ensuring Adherence to Standards for Analytical Laboratory Use

    Eurolabs EP 2.2.20 Thin-Layer Chromatography Identity Testing service includes water quality testing as part of its comprehensive analytical program. The primary standards for water quality are:

  • ISO 3696: Water for Analytical Laboratory Use Specification and Test Methods

  • ASTM D1193-15: Standard Specification for Reagent Water

    • Water Quality Standards

    The standards for water quality ensure that laboratory samples meet specific requirements for purity, clarity, and chemical composition.

  • pH range: 5.5 to 8.5

  • Conductivity: Less than 1 μS/cm

  • Total Dissolved Solids (TDS): Less than 100 mg/L

    • Water Quality Testing

    Eurolabs water quality testing services include:

  • pH measurement

  • Conductivity measurement

  • TDS analysis

    • Water Quality Challenges

    Ensuring compliance with water quality standards can be challenging due to:

  • Source variability: Water sources may vary in quality and composition.

  • Laboratory variability: Laboratory equipment and personnel may introduce variability in test results.

  • Regulatory changes: Regulatory requirements for water quality may change over time.

    • Water Quality Conclusion

    Eurolabs EP 2.2.20 Thin-Layer Chromatography Identity Testing service ensures compliance with standards for analytical laboratory use, including water quality testing. By adhering to these requirements, companies can ensure accurate and reliable test results.

    ---

    TLC Analysis: A Comprehensive Overview

    Thin-Layer Chromatography (TLC) is a powerful analytical technique used to separate, identify, and quantify compounds in various samples. TLC involves applying a sample mixture onto a thin layer of silica gel or alumina coated on a glass plate. The plate is then developed using a solvent system, causing the compounds to migrate based on their affinities for the stationary phase.

    TLC Applications

    TLC has various applications in analytical chemistry, including:

  • Purification: TLC can be used to separate and purify compounds from complex mixtures.

  • Identification: TLC is a useful tool for identifying unknown compounds or verifying compound identity.

  • Quantitation: TLC can be used to quantify the concentration of compounds in a sample.

    • TLC Advantages

    TLC offers several advantages, including:

  • High sensitivity: TLC can detect and quantify compounds at very low concentrations.

  • Rapid analysis: TLC is a relatively fast analytical technique compared to other methods.

  • Low cost: TLC is a cost-effective analytical method, making it suitable for routine quality control testing.

    • TLC Limitations

    While TLC has several advantages, it also has some limitations:

  • Limited resolution: TLC may not provide the same level of resolution as other analytical techniques.

  • Sample preparation: TLC requires careful sample preparation to ensure accurate results.

  • Interpretation: TLC data interpretation can be complex and require expertise.

    • TLC Conclusion

    Thin-Layer Chromatography (TLC) is a powerful analytical technique used to separate, identify, and quantify compounds in various samples. Eurolabs testing services include TLC analysis as part of its comprehensive quality control program.

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