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Herbal Drug Analysis
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High-Performance Thin-Layer Chromatography

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• Reproducibility and Automation

• Visual Documentation

• Compliance with International Standards

Regulatory Compliance

• HPTLC is recognized in pharmacopeias like the United States Pharmacopeia (USP), European Pharmacopeia (Ph. Eur.), and Indian Pharmacopoeia (IP). Adhering to chapters such as USP <203>, Ph. Eur. 2.8.25, or Indian Ph. 2.4.17, HPTLC ensures compliance and quality in herbal products. Whether inspecting goods, controlling production, or conducting quality checks on finished products, our standardized HPTLC methods provide a reliable way to identify natural materials through their unique chromatographic fingerprints.

• This capability is crucial for:

  • Verifying the authenticity of botanical materials
  • Informing about the natural variability of botanicals
  • Checking quality of finished products
  • Detecting adulteration and ensuring purity
  • Monitoring stability over time
  • Quantifying active marker compounds

HPTLC APPLICATION IN
HERBAL DRUG ANALYSIS

• Complex Matrix Analysis

  One of the most notable applications of HPTLC is its ability to handle complex matrices effectively. This is exemplified in our case study on Ginkgo leaves and dry leaf extracts, commonly used in herbal drugs and botanical dietary supplements. The versatility and precision of HPTLC make it an invaluable tool in this context.

• Quality Control

  HPTLC is widely used for the quality control of raw plant materials and finished herbal products. By offering clear visual documentation of chemical profiles, it ensures the authenticity and purity of herbal substances. Adulteration and contamination, which are common risks in the herbal industry, can be easily detected through this method.

• Fingerprint Analysis

  Herbal drugs contain a variety of compounds that contribute to their therapeutic properties. HPTLC is highly effective in generating unique “fingerprints” for these complex mixtures, allowing for the identification and comparison of different plant species or extracts. This is essential for confirming the identity of herbal ingredients and ensuring that the correct plant species is used.

• Detection of Adulteration

  Adulteration in herbal drugs is a significant concern, particularly when cheaper or lower-quality plants are substituted for authentic ingredients. HPTLC enables the detection of such adulterants by comparing the chemical profile of the herbal product with reference standards. This provides an easy and efficient way to safeguard the integrity of herbal products.

• Stability Testing

  Herbal formulations are sensitive to environmental factors such as temperature, light, and humidity, which can affect their stability and shelf life. HPTLC is used to monitor the stability of herbal drugs by tracking changes in their chemical composition over time. This ensures that herbal medicines maintain their potency and safety throughout their shelf life.

• Quantification of Active Marker Compounds

  The complex chemical makeup of herbal drugs presents challenges in maintaining consistency across batches. HPTLC helps in the standardization of herbal extracts by identifying and quantifying key bioactive markers. This ensures that each batch of herbal product meets the required quality standards, providing reliable therapeutic effects.

• Universal Separation Approach

  Laboratories performing HPTLC analysis face challenges with multiple methods and standards. A new approach using three complementary developing solvents (CDS) allows to separate all components in at least one of the three systems. This method, demonstrated in identifying herbal drugs, can be automated with HPTLC PRO, reducing costs and consumables. The CDS approach makes HPTLC a versatile and efficient technique for analyzing complex samples and individual compounds.

• Multi-Component Analysis

  Herbal drugs often contain numerous active compounds, each contributing to the overall therapeutic effect. HPTLC is an ideal tool for multi-component analysis, allowing the simultaneous detection and quantification of several compounds in a single run. This saves time and provides a comprehensive understanding of the herbal product’s composition.

Chromap founded in 2016, is committed to establish a Chinese medicine R&D company with a “craftsmanship spirit.” The extractive reference substances (ERS) and formula granules of TCM that we have developed, which are part of national standard research projects, have received recognition from experts both domestically and internationally. Our laboratory is equipped with multiple sets of CAMAG HPTLC equipment, achieving standardized parameters and automated processes to ensure the reproducibility of results.

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In 2016, Shanghai University of Traditional Chinese Medicine partnered with Jiangsu Kanion Pharmaceutical Co., Ltd. to establish Shanghai Tufeng Medical Technology Co., Ltd., and jointly founded the Kanion Pharmaceutical Research Institute at Shanghai University of TCM. The Research Institute is responsible for the R&D and application of some new TCM drugs. The TLC identification is an essential part of the application process. With the assistance of equipment such as CAMAG’s ATS 4 and TLC Visualizer, the data from the TLC identification can be ensured to be repeatable and traceable, which is very important for the work of new drug applications.

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Food Analysis
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High-Performance Thin-Layer Chromatography

• Fast and Efficient
• Reliable and Reproducible
• Cost-Effective
• Compliant with Regulatory Standards

HPTLC application in
Food Analysis

• Food Safety and Contaminants

  Food safety is a paramount concern, with contaminants defined as substances unintentionally added to food during various stages of production or due to environmental factors. HPTLC’s robust and cost-effective methodology is ideal for analyzing a wide range of contaminants and impurities in different food matrices, such as mycotoxins, antibiotics, and illegal dyes. This same level of precision and efficiency extends to feed sample analysis.

• Quality Control of Ingredients

  Monitoring the quality of raw ingredients is essential to ensure that the final product meets regulatory and consumer standards. HPTLC can be used to assess the purity and composition of ingredients such as herbs, spices, flavorings, and essential oils. This allows manufacturers to maintain consistency and quality throughout the production process.

• Monitoring Natural Food Products

  Natural food products such as plant extracts, essential oils, and organic ingredients are becoming increasingly popular. HPTLC allows for the precise analysis of these natural compounds, ensuring they are of the highest quality and free from contaminants.

• Nutritional Analysis

  HPTLC can be employed in the analysis of nutrients like vitamins, antioxidants, and amino acids in food products. This ensures that the nutritional content matches the product labeling and meets the health standards required by regulatory agencies.

• Additive and Preservative Testing

  HPTLC is highly effective in identifying and quantifying preservatives, colorants, and other additives in food products. This ensures compliance with regulatory limits and helps manufacturers avoid potential health risks associated with excessive additive use.

• Identification of Fixed Oils

  CAMAG has developed HPTLC methods for identifying vegetable oils in compliance with Ph. Eur. and USP standards. These methods differentiate fixed oils from volatile and essential oils, ensuring authenticity, quality, and detecting adulteration in food products. A recent example includes detecting paraffin oil in milk using the HPTLC PRO system.

• Analysis of Steviol Glycosides

  With the increasing popularity of low-calorie sweeteners like Stevia rebaudiana, CAMAG’s HPTLC systems offer precise tools for analyzing these sweeteners in various food matrices, as demonstrated in our case study on the quantitative determination of steviol glycosides.

• Detection of Estrogen Active Compounds in Beer

  Another innovative application of HPTLC is in the detection of endocrine active compounds (EACs) in food and water, as shown in our study using HPTLC direct bioautography. This method is sensitive enough to detect EACs in the very low µg/kg range, crucial for assessing their impact on the human endocrine system.

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Forensic Analysis
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High-Performance Thin-Layer Chromatography

• High Sensitivity and Accuracy
• Simultaneous Multi-Sample Analysis
• Non-Destructive Analysis
• Regulatory Compliance

HPTLC APPLICATION IN
FORENSIC ANALYSIS

• Efficient Identification of Falsified Products

  HPTLC facilitates efficient substance identification and visual fingerprint identification to detect falsified products. Spectra from illicit substances can be compared to unknown substances in falsified products to confirm their presence. HPTLC-MS as an additional method can confirm the identity of the illicit substance.

• Complementing Techniques for Purity Assurance

  Normal-phase HPTLC is an excellent complementary technique to RP-18 HPLC, especially for quality control purposes. HPTLC plates can reveal impurities that might not be detected by HPLC, thus providing a more comprehensive purity assessment. Our case study on the chemical synthesis of ergoline psychedelics demonstrates HPTLC’s effectiveness in process monitoring and purity analysis of finished products.

• Forensic Drug Control

  CAMAG’s HPTLC systems are designed to meet the expert’s needs for successful analysis of various types of illicit drugs in different matrices. Forensic drug control covers diverse challenges, from assessing chemical purity to identifying illicit drugs. While LC-MS and GC-MS are commonly used, HPTLC provides faster and reliable results in many cases.

• Analysis of Explosives based on Chemical Residues

  HPTLC is used to analyze chemical residues from explosives, accelerants, and other hazardous substances at crime scenes. This method allows investigators to identify the specific chemicals involved, helping to establish the cause of an explosion or arson.

• Document Forgery

  In cases of document forgery, HPTLC can be employed to analyze inks. By separating the chemical composition of inks, HPTLC can distinguish between different inks used in a document, aiding in the detection of alterations, forgeries, or counterfeit documents.

• Dyestuff Analysis

  The analysis of food colorants is a critical aspect of food safety and quality control. Whether natural or synthetic, color additives must meet strict regulatory standards, and HPTLC provides a reliable solution for ensuring compliance.

• Detection of Chemical Warfare

  Chemical warfare agents, whether solid, liquid, or gas, can harm humans, animals, or plants even in small amounts. Given their potential use in warfare and terrorism, CAMAG has developed HPTLC methods to identify and detect nerve agents, blister agents, irritants, and arsenic-based agents. HPTLC instruments reduce direct contact with toxic samples, enhancing analyst safety during the detection process.

• Cannabis Analysis

  HPTLC is an essential tool in the cannabis industry, providing fast, reliable, and cost-effective analysis for cannabinoid profiling, terpene analysis, and contaminant detection. Its versatility and precision help manufacturers and testing labs ensure the quality, safety, and compliance of cannabis products, meeting the growing demands of the industry and regulatory bodies.

• Shooting Distance Determination

  For shooting distance determination, burned powder particles can be imprinted on filter paper and detected by spraying reagents. The Derivatizer, compared to manual spraying, delivers user-independent, higher-resolution images and improved health protection, and provides more consistent, reproducible results, making it a preferred tool for shooting distance determination.

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Biotechnology Analysis
with CAMAG’s HPTLC Systems

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High-Performance Thin-Layer Chromatography

• High Sensitivity and Accuracy
• Multi-Component Analysis
• Cost-Effective
• Automation and Documentation

HPTLC APPLICATION IN BIOTECHNOLOGY

• Optimizing Production Processes

  In the life sciences sector, the optimization of production processes with minimal interruptions is crucial. HPTLC supports this need by enabling the analysis of multiple samples simultaneously, often with minimal or no sample preparation. This high-throughput capability, combined with low costs per sample, makes HPTLC an efficient choice for biotechnology applications.

   

• Versatility and Efficiency in Analysis

  HPTLC offers the unique advantage of evaluating a plate at any stage of the analytical process. It allows for the use of various detection modes, such as UV and fluorescence, in sequence when required. This versatility is essential for quantifying active ingredients, analyzing impurities in finished products, monitoring production processes, and validating the cleanliness of production units.

• In-Process Control

  HPTLC’s ability to rapidly analyze samples is particularly beneficial for in-process control, ensuring that production stages are proceeding correctly and efficiently.

• Quality Control of Finished Products

  The technique is also invaluable for the quality control of finished biotech products, ensuring that they meet the required standards and specifications.

• Cleaning Validation

  HPTLC plays a critical role in cleaning validation, confirming that production units are thoroughly cleaned and free from contaminants before the commencement of a new production cycle or before the change-over to a new production process in the same production line.

• Analysis of Biomolecules

  HPTLC is widely used to analyze various biomolecules such as proteins, peptides, nucleic acids, lipids, and carbohydrates. The technique provides a clear and reproducible separation of these molecules, allowing for accurate identification and quantification in complex mixtures.

• Metabolite Profiling

  In biotechnology, understanding the metabolic pathways of organisms is crucial for research and development. HPTLC can be used to profile metabolites in cell cultures, fermentation broths, or plant extracts, providing valuable insights into cellular processes and the production of secondary metabolites.

• Analysis of Fermentation Products

  Fermentation is a key process in biotechnology for the production of biofuels, food products, and pharmaceuticals. HPTLC aids in monitoring and analyzing the by-products and active compounds generated during fermentation, ensuring the process is optimized for yield and quality.

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Cosmetics Analysis
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High-Performance Thin-Layer Chromatography

• High Sensitivity and Accuracy
• Cost-Effective and Efficient
• Non-Destructive Testing
• Visual Documentation

HPTLC APPLICATIONS IN COSMETICS ANALYSIS

• Natural Extracts and Essential Oils Analysis

  Many cosmetic products rely on natural ingredients like plant extracts and essential oils. HPTLC provides a reliable method for analyzing these complex mixtures, ensuring their authenticity and purity. This helps manufacturers guarantee the quality and effectiveness of their natural-based cosmetic formulations.

• Identification of Active Ingredients

  HPTLC is widely used to identify and verify the presence of active ingredients in cosmetic products such as creams, lotions, and serums. By ensuring that active compounds are present in the correct concentrations, HPTLC helps maintain product efficacy and regulatory compliance.

• Standardized Methods for Reliable Results

  The use of standardized HPTLC methods enables the clear identification of natural materials based on their chromatographic fingerprint, regardless of the source. HPTLC is also a powerful tool for rapidly comparing multiple samples in parallel, checking for adulteration, monitoring purity and stability, and quantifying marker compounds.

• UV Filters in Sun Cream

  This method demonstrates HPTLC’s effectiveness in identifying UV filters, a critical component in sun protection products.

• Qualification of Edelweiss Extracts and Glycerol-Based Ingredients

  This application highlights HPTLC’s role in detecting phenolic markers specific to Edelweiss species, aiding in the qualification of raw materials and glycerol-based cosmetic ingredients used in cosmeceuticals.

• Tackling the Complexity of Cosmetic Mixtures

  Cosmetic products are often intricate mixtures, making their analysis challenging due to potential interferences from various components. The integration of active ingredients into diverse formulations necessitates the development of precise analytical methods for quality control. HPTLC’s capability to handle these complex matrices makes it an ideal choice for the cosmetic industry.

• Quality Control and Product Consistency

  Ensuring consistency across batches is critical for maintaining brand reputation and consumer trust. HPTLC allows manufacturers to monitor the composition of cosmetic products and raw materials, ensuring uniformity in quality and performance from batch to batch.

• Detection of Contaminants and Adulterants

  HPTLC is a powerful tool for detecting harmful contaminants such as pesticides or synthetic adulterants that may be present in raw materials or finished cosmetic products. This ensures that products are safe for consumer use and meet safety standards.

• Analysis of Preservatives and Additives

  Cosmetic products often contain preservatives, antioxidants, and colorants to enhance their stability and appearance. HPTLC is used to identify and quantify these additives, ensuring they are within safe and legal limits. It helps manufacturers avoid issues related to excessive use of preservatives or unauthorized colorants.

• Detection of Microbial Contaminants

  Microbial contamination can lead to product degradation and pose health risks to consumers. HPTLC assists in the detection of microbial by-products or components in cosmetic formulations, ensuring that products are microbiologically safe and stable over time.

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Pharmaceutical Analysis
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High-Performance Thin-Layer Chromatography

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HPTLC application in
Pharmaceutical Analysis

• Addressing Analytical Challenges

  The pharmaceutical industry faces various analytical challenges, including process control during chemical synthesis, quality control, and cleaning validation. Optimized production processes with minimal interruptions between cycles are essential for manufacturers of pharmaceuticals and related consumer goods. HPTLC’s ability to analyze multiple samples simultaneously, often with minimal or no sample preparation, makes it a high-throughput technique that is both efficient and cost-effective.

• Versatile and Efficient Analytical Process

  HPTLC offers the unique advantage of evaluating a plate at any stage of the analytical process. It allows for the use of various detection modes, such as UV and fluorescence, in sequence when required. This versatility is crucial for quantifying active ingredients, analyzing impurities in finished products, monitoring production processes, and validating the cleanliness of production units.

• Sanofi’s Cleaning Strategy

  A notable application of HPTLC is in the cleaning strategy of Sanofi at their API (Active Pharmaceutical Ingredient) production site in Aramon, France. This approach, applicable to any production plant worldwide, is detailed in the case study “Cleaning validation at API production units”. It demonstrates HPTLC’s effectiveness in ensuring the cleanliness of production vessels and trains, a critical aspect of pharmaceutical manufacturing.

• Quality Control and Assurance

  HPTLC plays a vital role in monitoring the quality of pharmaceutical raw materials, intermediates, and finished products. By providing clear separation of drug compounds and impurities, it ensures that pharmaceuticals meet the stringent regulatory standards set by bodies like the FDA and EMA.

• Identification and Purity Testing

  HPTLC is particularly effective in identifying and verifying the purity of active pharmaceutical ingredients (APIs). It allows for the rapid screening of multiple samples simultaneously, reducing time and cost while ensuring accurate results. This technique is commonly used to identify herbal components in traditional medicine, synthetic drugs, and biologics.

• Degradation Studies

  Pharmaceutical products are susceptible to degradation due to environmental factors such as light, heat, and humidity. HPTLC helps in the identification of degradation products, ensuring that the pharmaceutical formulations maintain their stability and efficacy over time.

• Content Uniformity Testing

  In dosage form testing, HPTLC is used to verify that the active ingredients are evenly distributed throughout a batch of tablets or capsules. This ensures consistent dosing for patients and is a key part of regulatory compliance.

• Impurity Profiling

  Detecting impurities, even at trace levels, is critical to pharmaceutical safety. HPTLC is a valuable tool for impurity profiling, providing a fast and reliable way to identify and quantify unwanted substances in drug formulations. Its high sensitivity makes it suitable for detecting degradation products, residual solvents, or synthetic by-products.

• Stability Testing

  Stability testing is a crucial part of the drug development process. HPTLC helps monitor the stability of pharmaceutical products under different conditions, ensuring that they maintain their potency and safety throughout their shelf life.

The use of CAMAG instrumentation (ATS 4, ADC 2, TLC Visualizer, TLC Scanner 4, visionCATS) helps us to quickly develop and optimize separation conditions, later transposed to preparative columns, and analyze products coming from these purifications. Clearly a method of choice in the field of fast development of new pharmaceutic molecules!

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Chemical Analysis
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HPTLC application in Chemical Analysis

• Sanofi’s Cleaning Strategy

  HPTLC plays a crucial role in the cleaning strategy at Sanofi’s API production site in Aramon, France. This method, applicable for cleaning production plants globally, is detailed in the case study “Cleaning validation at API production units”.

• Analysis of Biodiesel

  The team from CSIC, Instituto de Carboquímica, in Zaragoza, Spain, utilized HPTLC to investigate monoacylglycerides in biodiesel and blended diesel fuel. This method is crucial for ensuring compliance with European standards and for in-process control during biodiesel production.

• High Throughput and Cost-Efficiency

  HPTLC enables the simultaneous analysis of multiple samples, often with little to no sample preparation. This makes it a high-throughput technique that is both time-efficient and cost-effective. Additionally, HPTLC allows for the evaluation of a plate at any stage of the analytical process and the use of various detection modes, such as UV and fluorescence, in sequence when necessary.

• Raw Material Testing

  The quality of raw materials directly impacts the success of chemical manufacturing. HPTLC provides an effective method for the identification and verification of raw materials, ensuring that only high-quality inputs are used in production. This helps to prevent costly errors or contamination in downstream processes.

• Identification and Quantification of Organic Compounds

  HPTLC is highly efficient at separating and identifying organic compounds, making it ideal for analyzing chemicals such as polymers, surfactants, dyes, and pigments. By detecting and quantifying these components, HPTLC supports the development of new chemical formulations and quality control of existing products.

• Impurity Profiling

  Detecting impurities in chemical formulations is crucial for both safety and performance. HPTLC enables the identification and quantification of trace impurities in raw materials or final products, helping manufacturers maintain product purity and comply with regulatory requirements.

• Reaction Monitoring

  In chemical synthesis, monitoring reaction progress is essential for optimizing production and ensuring consistent quality. HPTLC allows chemists to track the conversion of reactants to products in real-time, providing a quick and reliable way to ensure reactions are proceeding as expected.

• Additive and Catalyst Analysis

  Many chemical processes require additives or catalysts to enhance performance or efficiency. HPTLC is effective at analyzing the presence and concentration of these additives, ensuring they are used at optimal levels for the desired chemical outcomes.

• Environmental and Regulatory Compliance

  The chemical industry must adhere to strict environmental regulations. HPTLC helps detect and quantify harmful substances, such as pollutants and by-products, ensuring compliance with environmental standards. This is crucial in reducing the environmental impact of chemical manufacturing and ensuring sustainable practices.

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Environmental Analysis
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HPTLC application in Environmental Analysis

• Applications in Water Quality Monitoring and Beyond

  HPTLC is particularly adept at monitoring water quality, providing a reliable method for assessing the presence of chemical residues and contaminants. It’s not limited to water analysis; HPTLC can also be used for examining residues in soil, manure, crops, and leachate water from landfill sites.

• Advanced Techniques: Coupling HPTLC with Effect-Directed Analysis

  By combining HPTLC with effect-directed analysis (EDA), known and unknown toxins in environmental samples can be detected. Large water volumes are concentrated on the HPTLC plate for analysis, followed by effect-directed assays like Aliivibrio fischeri, AChE, pYES, and Bacillus subtilis. This method provides valuable insights into the chemical properties and toxicity of the separated analytes directly on the plate without any cumbersome sample collection process.
  

• Pollutant Detection

  HPTLC is used to detect and quantify a variety of pollutants, such as industrial chemicals and organic contaminants, in water and soil samples. This allows environmental scientists to monitor the presence and concentration of harmful substances, ensuring they do not exceed regulatory limits.

• Pesticide and Herbicide Residue Analysis

  Monitoring pesticide and herbicide residues is essential to assess the impact of agricultural practices on the environment. HPTLC provides a reliable method for detecting trace amounts of these compounds in water, soil, and food products, ensuring environmental safety and regulatory compliance.

• Analysis of Persistent Organic Pollutants (POPs)

  Persistent Organic Pollutants (POPs) are chemicals that remain in the environment for long periods, accumulating in ecosystems and posing health risks. HPTLC is highly effective in identifying and quantifying POPs such as dioxins, PCBs, and PAHs, helping researchers track environmental contamination and its effects on wildlife and human health.

• Wastewater and Industrial Effluent Testing

  HPTLC is employed in the analysis of wastewater and industrial effluents to monitor harmful substances like dyes and chemicals. This ensures that industries meet environmental standards by properly treating waste before release, reducing their impact on ecosystems.

• Biomonitoring

  HPTLC is used in biomonitoring to assess the exposure of plants, animals, and humans to environmental pollutants. By analyzing biological samples such as tissue or fluids, it helps identify bioaccumulation of toxins and their potential health effects.

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