Whether your company is looking for a lab to perform its quality assurance/quality control testing, or to provide analytical services that you can’t complete in-house, Alera Labs are here to help you.  Our chemical testing services can be customized to fit the needs of a wide range of companies and industries. Alera Labs’ chemical testing services include but not limited to: testing raw materials, solvent testing, contaminant identification, litigation support and more. We have developed expertise in identifying and characterizing unknowns through analytical techniques, materials testing, and expert interpretations.

At Alera Labs we provide an array of crucial services to ensure the safety, efficacy, and regulatory compliance of your chemical products.
Our offerings include the development and validation of a broad range of analytical assays, execution of forced degradation studies along with the development of stability indicating assays, comprehensive stability testing, and method optimization, troubleshooting, and transfer.
Additionally, we provide services for the development, validation, and sample analysis for dose verification testing in alignment with Good Laboratory Practice (GLP) toxicology studies. 

We specialize in structure elucidation and impurity identification, using advanced techniques to provide detailed insights into the molecular structures of your compounds and detect any unwanted impurities. With our expertise and state-of-the-art tools, we are dedicated to delivering reliable, high-quality data that supports your product development and quality control efforts.

1. Development and validation of a wide spectrum of analytical assays

Techniques used: HPLC, GC-MS, LC-MS, LC-MS/MS

 
This process involves designing and confirming the reliability of various analytical methods tailored to the specific needs of the chemical industry. These assays can range from determining the composition and concentration of chemical compounds to assessing their physical properties. Validation is a crucial step that ensures these methods yield accurate, consistent, and reproducible results under predefined conditions, thus providing reliable data for decision-making.

Alera Labs is a trusted partner in the chemical industry, specializing in the development and validation of a wide spectrum of analytical assays. Our expertise spans multiple techniques, including HPLC, GC-MS, LC-MS, LC-MS/MSenabling us to provide tailored analytical solutions for diverse chemical applications.

Development of analytical assays in the chemical industry involves designing methods that are specific to the compounds and properties being analyzed. Our experienced team collaborates closely with clients to understand their specific needs and develop customized assays that address their analytical requirements. Whether it’s determining the composition and concentration of chemical compounds, assessing physical properties, or conducting specialized analyses, we have the expertise to design assays that meet the unique challenges of the chemical industry.

Validation is a critical step in ensuring the reliability and accuracy of analytical assays. At Alera Labs, we follow rigorous protocols and industry guidelines to validate the developed assays. This includes assessing key performance parameters such as accuracy, precision, linearity, sensitivity, and selectivity. Through validation, we establish the robustness and reproducibility of the methods, providing clients with reliable and consistent data for their decision-making processes.

Use case scenarios:

1. Chemical composition analysis: A chemical manufacturer needs to determine the composition of a complex mixture. Alera Labs develops and validates an HPLC or GC method that separates and quantifies individual components in the mixture, providing accurate composition data.

2. Impurity identification: A pharmaceutical company wants to identify impurities in their chemical compound. Alera Labs employs LC-MS or LC-MS/MS techniques to develop and validate an assay that can detect and quantify impurities, ensuring the compound meets purity standards.

3. Moisture content analysis: A chemical supplier needs to determine the moisture content in their product. Alera Labs utilizes the Karl Fischer method, a specialized technique for moisture determination, to develop and validate an assay that accurately measures the moisture content of the product.

4. Elemental analysis: A material manufacturer requires elemental analysis of their product. Alera Labs utilizes ICP-MS technology to develop and validate an assay that can detect and quantify trace elements, ensuring compliance with quality control standards.

At Alera Labs, we are committed to providing reliable and accurate analytical assays for the chemical industry. Our team of experts leverages their knowledge and expertise in HPLC, GC-MS, LC-MS, LC-MS/MS, Karl Fischer and ICP-MS techniques to deliver high-quality analytical solutions. Contact Alera Labs today to discuss your specific analytical needs and ensure reliable data for your chemical applications.

2. Forced degradation studies and stability indicating assays development 

Techniques used: HPLC, GC-MS, LC-MS, LC-MS/MS

Forced degradation studies involve subjecting the chemical substance to various stress conditions (such as heat, light, humidity, and pH extremes) to simulate the potential degradation of the substance over time. The data from these studies is crucial in understanding the stability of the compound and identifying potential degradation products. Stability indicating assays are developed alongside these studies, offering a validated method to monitor the stability of the chemical substance over its shelf life.

Alera Labs is a trusted partner in the chemical industry, specializing in forced degradation studies and the development of stability indicating assays. With expertise in HPLC, GC-MS, LC-MS, and LC-MS/MS techniques, we offer comprehensive solutions to assess the stability and integrity of chemical substances.

Forced degradation studies are conducted to simulate the degradation pathways and potential breakdown of chemical substances under various stress conditions. By subjecting the substance to factors like temperature, light, humidity, and pH extremes, we can understand how it may degrade over time. These studies provide valuable insights into the stability of the substance, helping manufacturers identify potential degradation pathways and develop strategies to mitigate degradation.

Alongside forced degradation studies, we develop stability indicating assays. These assays are specifically designed and validated to monitor the stability of the chemical substance over its shelf life. By using techniques such as HPLC, GC-MS, LC-MS, and LC-MS/MS, we can accurately analyze the substance and detect any degradation products or impurities that may form over time. The development and validation of stability indicating assays ensure that manufacturers have reliable methods to assess the stability and integrity of their chemical products.

Use case scenarios:

1. Pharmaceutical stability studies: A pharmaceutical company needs to evaluate the stability of an active pharmaceutical ingredient (API) under different storage conditions. Alera Labs performs forced degradation studies, exposing the API to temperature, humidity, and light, while also developing stability indicating assays using HPLC, LC-MS, or LC-MS/MS. The results help determine the shelf life and storage requirements for the API.

2. Chemical product shelf life assessment: A chemical manufacturer wants to determine the shelf life of their product to ensure its quality and performance. Alera Labs conducts forced degradation studies under various stress conditions, such as high temperature and exposure to light. Additionally, we develop stability indicating assays using GC-MS or LC-MS techniques to monitor the degradation products over time and assess the product’s stability.

3. Food and beverage preservation studies: A food and beverage company aims to develop a new preservative for their products. Alera Labs performs forced degradation studies to assess the preservative’s stability under different storage conditions. By using HPLC, LC-MS, or LC-MS/MS techniques, we develop stability indicating assays to monitor the preservative’s degradation and ensure its effectiveness in extending the shelf life of food and beverage products.

At Alera Labs, we understand the importance of forced degradation studies and stability indicating assays in the chemical industry. Our experienced team leverages HPLC, GC-MS, LC-MS, and LC-MS/MS techniques to provide reliable data on the stability and integrity of chemical substances. Contact us today to discuss your specific needs and ensure the quality and longevity of your chemical products.

3. Stability testing

Techniques used: HPLC, GC-MS, LC-MS, LC-MS/MS 

This service provides an assessment of how the quality of a chemical product changes over time under the influence of environmental factors such as temperature, humidity, and light. Stability testing data can support expiration date setting, storage conditions, and packaging types for chemicals and chemical products.

Alera Labs is a trusted partner in the chemical industry, offering comprehensive stability testing services to assess the quality and integrity of chemical products over time. With expertise in HPLC, GC-MS, LC-MS, and LC-MS/MS techniques, we provide valuable insights into product stability and support critical decision-making processes.

Stability testing is a vital service that evaluates how the quality of a chemical product changes under various environmental conditions, including temperature, humidity, and light exposure. By subjecting the product to controlled conditions over a specified period, we can assess its stability, degradation pathways, and potential changes in physical, chemical, and functional properties. The data generated from stability testing aids in setting appropriate expiration dates, determining optimal storage conditions, and selecting suitable packaging types for chemicals and chemical products.

Use case scenarios:

1. Pharmaceutical stability testing: A pharmaceutical company is developing a new drug formulation and needs to determine its stability under different storage conditions. Alera Labs conducts stability testing using HPLC, GC, LC-MS, or LC-MS/MS techniques to evaluate the chemical’s degradation, impurity formation, and changes in potency over time. The data obtained helps establish shelf life, storage recommendations, and packaging requirements for the pharmaceutical product.

2. Chemical product shelf life assessment: A chemical manufacturer wants to assess the shelf life of a particular product to ensure its quality and performance over time. Alera Labs performs stability testing under controlled environmental conditions, monitoring the product’s properties using HPLC, GC-MS, LC-MS, or LC-MS/MS methods. The generated data helps determine the product’s expiration date, storage guidelines, and packaging considerations for maintaining its integrity.

3. Cosmetic product stability evaluation: A cosmetics company introduces a new formulation and wants to ensure its stability and performance throughout its intended shelf life. Alera Labs conducts stability testing using appropriate analytical techniques such as HPLC, GC-MS, LC-MS, or LC-MS/MS to evaluate the chemical composition, degradation, and changes in physical properties of the cosmetic product over time. This data assists in setting expiration dates, recommending storage conditions, and selecting suitable packaging materials for the product.

At Alera Labs, we understand the importance of stability testing in the chemical industry. Our state-of-the-art techniques and experienced team enable us to provide reliable and accurate data on the stability of chemical products. Contact us today to discuss your specific needs and ensure the quality and longevity of your chemical products.

4. Method optimization, troubleshooting, and transfer

Techniques used: HPLC, GC-MS, LC-MS, LC-MS/MS

 
Method optimization involves fine-tuning the parameters of analytical methods to improve their performance, such as reducing the time required for analysis or improving sensitivity. Troubleshooting addresses any issues that arise during testing to ensure that the results are valid and reliable. Method transfer is the process of qualifying a laboratory to use an analytical test procedure that originated in another lab, ensuring that the method performs the same in the receiving laboratory as it did in the original one.

Alera Labs understands the unique needs of the chemical industry and offers comprehensive services in method optimization, troubleshooting, and method transfer. Leveraging our expertise in HPLC, GC-MS, LC-MS, and LC-MS/MS techniques, we optimize analytical methods to enhance their performance, resolve issues through troubleshooting, and ensure seamless method transfer between laboratories.

Method optimization is a critical step in improving the efficiency, accuracy, and sensitivity of analytical methods. Our experienced team fine-tunes the parameters of HPLC, GC-MS, LC-MS, or LC-MS/MS methods to optimize separation, reduce analysis time, enhance detection limits, and improve overall method performance. By employing advanced techniques and innovative approaches, we help maximize the productivity and reliability of chemical analyses.

Troubleshooting is an essential aspect of the analytical process. Our experts are skilled in identifying and resolving issues that may arise during testing, such as instrument malfunctions, inconsistent results, or unexpected interferences. Through rigorous analysis, we diagnose and troubleshoot problems to ensure the accuracy and reliability of the obtained data.

Method transfer is crucial when an analytical test procedure needs to be qualified for use in a different laboratory. We ensure that the method’s performance remains consistent and reliable throughout the transfer process. By meticulously validating and verifying the method in the receiving laboratory, we ensure that the same reliable results are obtained, maintaining the integrity and comparability of the analytical data.

Use case scenarios:

1. Method optimization: A chemical company seeks to improve the efficiency and sensitivity of an analytical method for quantifying impurities in their products. Alera Labs conducts method optimization using HPLC, GC-MS, LC-MS, or LC-MS/MS techniques to enhance separation, sensitivity, and reduce analysis time. The optimized method enables accurate and reliable detection of impurities in the chemical products.

2. Troubleshooting: During routine analysis, a chemical laboratory encounters unexpected inconsistencies in the obtained results. Alera Labs performs troubleshooting to identify and resolve the underlying issues. By evaluating instrument performance, sample preparation techniques, and potential interferences, we address the problems and ensure the generation of reliable and consistent data.

3. Method transfer: A chemical company wants to transfer an established analytical method from one laboratory to another. Alera Labs conducts method transfer by carefully validating and verifying the method’s performance in the receiving laboratory. This ensures that the same reliable results are obtained, maintaining the accuracy and consistency of the analytical data across different locations.

At Alera Labs, we are committed to optimizing methods, troubleshooting issues, and facilitating smooth method transfer in the chemical industry. Our expertise, combined with state-of-the-art techniques, ensures that your analytical processes are efficient, reliable, and consistent. Contact us today to discuss your specific needs and benefit from our method optimization, troubleshooting, and transfer services.

5. Development, validation, and sample analysis for dose verification testing for GLP toxicology studies

Techniques used: HPLC, GC-MS, LC-MS, LC-MS/MS 

This service involves creating and validating testing methods for accurately measuring the dose of chemical substances in toxicology studies conducted under Good Laboratory Practice (GLP) conditions. Sample analysis is then performed to provide critical data for these studies, which are often required for regulatory submissions.

Alera Labs recognizes the importance of accurate dose verification testing in GLP toxicology studies within the chemical industry. We offer comprehensive services encompassing the development, validation, and sample analysis of testing methods to ensure precise measurement of chemical substance doses. Our expertise, combined with HPLC, GC-MS, LC-MS, and LC-MS/MS techniques, allows us to deliver reliable and high-quality results.

Development: Our experienced team develops testing methods tailored specifically for dose verification in toxicology studies. We carefully design and optimize the methods to accurately quantify the dosage of chemical substances under investigation. Through meticulous method development, we ensure the methods are robust, sensitive, and meet the specific requirements of GLP regulations.

Validation: Validation is a crucial step in ensuring the accuracy, precision, and reliability of the developed testing methods. We perform comprehensive validation studies to verify the suitability of the methods for their intended purpose. This includes evaluating parameters such as selectivity, linearity, accuracy, precision, and robustness. By following established validation protocols and guidelines, we provide assurance that the methods deliver accurate and consistent results.

Sample Analysis: Once the methods are developed and validated, we conduct sample analysis for dose verification testing. Our state-of-the-art HPLC, GC-MS, LC-MS, and LC-MS/MS techniques enable us to accurately analyze samples and quantify the chemical substances of interest. We adhere to strict quality control measures throughout the analysis process to ensure reliable and precise measurement of doses.

Use case scenario: A chemical company is conducting toxicology studies to evaluate the safety of a new chemical compound. They require accurate dose verification testing to determine the dosage levels administered to test subjects. Alera Labs develops a customized testing method using HPLC, GC-MS, LC-MS, or LC-MS/MS, specifically designed for this compound. The method undergoes rigorous validation to ensure its reliability and adherence to GLP standards. Subsequently, we perform sample analysis using the validated method, generating accurate data on the administered doses for the toxicology study.

At Alera Labs, we prioritize accuracy, precision, and regulatory compliance in dose verification testing for GLP toxicology studies within the chemical industry. Our expertise in method development, validation, and sample analysis, coupled with advanced analytical techniques, ensures reliable and high-quality data for regulatory submissions and informed decision-making. Contact us today to discuss your specific needs and benefit from our comprehensive services.

6. Structure elucidation and impurity identification 

Techniques used: HPLC, GC-MS, LC-MS, LC-MS/MS, FT-IR1D and 2D NMR

Structure elucidation involves determining the precise molecular structure of a chemical compound, which is critical in the chemical industry for product development, quality control, and regulatory compliance. Impurity identification, on the other hand, involves detecting and identifying any unwanted chemical substances that could affect the quality, safety, or efficacy of the chemical product. Advanced techniques such as mass spectrometry and nuclear magnetic resonance (NMR) spectroscopy are typically used for these tasks.

Alera Labs recognizes the significance of structure elucidation and impurity identification in the chemical industry. We offer comprehensive analytical laboratory services tailored specifically for these needs. Our expertise, combined with state-of-the-art techniques such as HPLC, GC-MS, LC-MS, LC-MS/MS, FT-IR, and NMR, allows us to deliver accurate and reliable results.

Structure elucidation: Our skilled team specializes in determining the precise molecular structure of chemical compounds. Through the application of advanced techniques such as mass spectrometry, NMR spectroscopy, and FT-IR spectroscopy, we analyze the chemical composition and bond connectivity to unveil the structural details. This information is essential for product development, quality control, formulation optimization, and regulatory compliance within the chemical industry.

Impurity identification: Detecting and identifying impurities in chemical products is crucial to ensure their quality, safety, and efficacy. Our laboratory employs a range of analytical techniques, including HPLC, GC-MS, LC-MS, LC-MS/MS, and NMR, to accurately detect and identify impurities. By comparing the obtained results with established databases and utilizing expert interpretation, we identify and characterize impurities present in the chemical substances, enabling appropriate remedial actions and quality control measures.

Use case scenario 1: A chemical manufacturer wants to ensure the purity and quality of a new chemical compound they have synthesized. They engage Alera Labs for structure elucidation services. Our team utilizes a combination of analytical techniques such as HPLC, LC-MS, and NMR spectroscopy to analyze the compound’s molecular structure, confirm its identity, and validate its purity.

Use case scenario 2: A chemical company needs to identify and quantify impurities in their chemical product. They approach Alera Labs for impurity identification services. Our team employs advanced analytical techniques such as GC-MS, LC-MS/MS to detect and characterize impurities. We compare the obtained data with reference standards and databases to accurately identify the impurities and determine their concentrations.

At Alera Labs, we understand the importance of structure elucidation and impurity identification in the chemical industry. Our comprehensive analytical laboratory services, coupled with advanced techniques, enable us to provide accurate and reliable results for product development, quality control, and regulatory compliance. Contact us today to discuss your specific needs and benefit from our expertise in structure elucidation and impurity identification.

Alera Lab provides analytical laboratory services for the chemical industry. We offer testing and analysis of various chemical compounds, raw materials, and finished products. This includes conducting specialized tests to assess purity, identify unknown compounds, perform materials testing, and provide expert interpretations and analysis.