Alera Labs provides an expansive range of analytical & testing services required for drug substances and API, intermediates, drug products and various finished dose forms. These services include analytical method development, method validation, stability testing, impurities identification and testing, residual solvents, extractables and leachables, raw materials, excipients, and others.
At Alera Labs, we are devoted to providing comprehensive analytical services for the pharmaceutical industry. Our expert team is equipped to perform a broad range of studies tailored to your specific needs. We specialize in the development and validation of analytical assays for various drug substances and drug products, ensuring accuracy and reliability in all of our testing processes. From stability testing and forced degradation studies to bioassays for pharmacokinetics studies, we are committed to supporting your drug development journey. We also conduct rigorous extractables and leachables studies in accordance with ISO 10993 and offer biocompatibility studies. Our services extend to method optimization, troubleshooting, and transfer, as well as dose verification testing for GLP toxicology studies. Recognizing the complexities in drug formulation, we offer formulation development for various drug products. In addition, we provide studies involving controlled drug substances and excel in structure elucidation and impurity identification. Trust Alera Labs to deliver exceptional, industry-leading analytical services designed to optimize your pharmaceutical research and development efforts.
Development and validation of wide spectrum of analytical assays for various drug substances and drug products
Techniques used: HPLC, LC-MS, LC-MS/MS, GC-MS
Alera Labs is a trusted provider of comprehensive analytical services, from HPLC and LC-MS/MS method development and validation to Karl Fischer moisture analysis. We ensure our services adhere to stringent quality controls, delivering reliable, accurate, and reproducible results for pharmaceutical drug substances and products.
Alera Labs offers expertise in developing and validating a wide range of analytical assays for drug substances and products, ensuring accurate and reliable results.
Alera Labs, a premier analytical service provider for the pharmaceutical industry, offers exceptional expertise in developing and validating a broad spectrum of analytical assays for a variety of drug substances and products. Utilizing advanced techniques such as High-Performance Liquid Chromatography (HPLC), Liquid Chromatography-Mass Spectrometry (LC-MS), Liquid Chromatography with tandem Mass Spectrometry (LC-MS/MS), and Gas Chromatography-Mass Spectrometry (GC-MS), our dedicated team ensures accurate, reliable, and reproducible results that align with regulatory standards.
Alera Labs excels in HPLC assay development and validation, a critical component for assessing drug purity, concentration, and stability. With a commitment to pharmaceutical LC-MS method development, our skilled scientists can analyze a wide range of compounds, supporting drug development processes from discovery through to production.
Leveraging the power of LC-MS/MS, Alera Labs offers a broad array of LC-MS/MS services for pharmaceuticals, ranging from bioanalytical method development and validation to purity analysis and impurity identification. Our team has deep expertise in LC-MS/MS bioanalysis, ensuring precise quantification and identification of drugs and metabolites in biological samples.
Through HPLC services, Alera Labs facilitates crucial aspects such as drug purity analysis, impurity profiling, stability testing, and assay development.
With our LC-MS and LC-MS/MS services, Alera Labs provides comprehensive bioanalytical method development, validation, and transfer, supporting both clinical and non-clinical studies. These services extend to pharmaceutical LC-MS/MS analysis, LC-MS/MS for API analysis, LC-MS/MS for raw material analysis, LC-MS/MS for in-process samples, and LC-MS/MS for finished product analysis.
For accurate moisture determination, we utilize the Karl Fischer method, renowned for its precision in determining water content in drug substances, excipients, and finished drug products. As a Karl Fischer analysis laboratory in North Carolina, Alera Labs offers Karl Fischer titration and moisture analysis services with fast turnaround times and competitive rates.
Alera Labs stands as your trusted partner for diverse analytical services such as HPLC, LC-MS, LC-MS/MS, and GC-MS. Our expert team ensures the development and validation of wide-spectrum analytical assays for your drug substances and products, meeting stringent quality standards and compliance requirements. Trust Alera Labs for reliable, high-quality analytical services tailored to your specific needs.
Forced degradation studies and stability indicating assays development
Techniques used: HPLC, GC-MS, LC-MS, LC-MS/MS
The company provides services that include forced degradation studies and the development of stability indicating assays, enabling comprehensive evaluation of drug stability over time.
Alera Labs offers key analytical solutions to the pharmaceutical industry that include forced degradation studies and the development of stability indicating assays. These services enable a comprehensive evaluation of drug stability over time and are conducted using techniques like High-Performance Liquid Chromatography (HPLC), Gas Chromatography-Mass Spectrometry (GC-MS), Liquid Chromatography-Mass Spectrometry (LC-MS), and Liquid Chromatography with tandem Mass Spectrometry (LC-MS/MS).
Our team of experts at Alera Labs performs forced degradation studies, accelerating the chemical, thermal, and photolytic stress conditions to assess the stability profile of drug substances and products. These studies, often sought by pharmaceutical companies as part of their quality control and regulatory compliance, help identify potential degradation products and establish the intrinsic stability of the molecule, thus aiding in the development of stability-indicating methodologies. Our forced degradation services span across areas such as pharmaceutical forced degradation studies, GC for degradation studies, HPLC for degradation studies, LC-MS/MS for degradation analysis, and contract lab for forced degradation studies.
Alera Labs also specializes in the development of stability-indicating assays. Our highly skilled scientists use HPLC, GC, LC-MS, and LC-MS/MS for stability assay development, providing reliable data for pharmaceutical stability testing, method development, and validation. These assays are invaluable in monitoring and confirming the integrity of drug substances and drug products during storage, providing insights for appropriate formulation, packaging, and shelf-life.
Alera Labs is a leading LC-MS/MS service provider and HPLC contract lab in North Carolina offering a comprehensive suite of services that encompass forced degradation studies and stability indicating assay development. Leveraging a combination of technical expertise and advanced techniques, we assure reliable and high-quality results for pharmaceutical companies to meet their stringent quality and regulatory standards.
Stability testing
Techniques used: HPLC, GC-MS, LC-MS, LC-MS/MS
Alera Labs conducts stability testing to assess the shelf-life and quality of pharmaceutical products under different storage conditions, ensuring their efficacy and safety.
In the dynamic world of the pharmaceutical industry, Alera Labs stands out as a trusted partner for comprehensive stability testing services. Utilizing such techniques like High-Performance Liquid Chromatography (HPLC), Gas Chromatography (GC), Liquid Chromatography-Mass Spectrometry (LC-MS), and Liquid Chromatography with tandem Mass Spectrometry (LC-MS/MS), our team assesses the quality and shelf-life of pharmaceutical products under varied storage conditions, ensuring their safety and efficacy.
With our HPLC stability testing, we provide precise and reliable data to evaluate the physical and chemical stability of your pharmaceutical products. Our HPLC services aid in detecting potential degradation products and assessing the impact of environmental factors on drug stability.
As an expert Gas Chromatography analytical service provider, Alera Labs offers comprehensive GC stability testing services. Our team ensures the precise quantification and identification of volatile impurities in drug substances and finished products, contributing to product safety and regulatory compliance.
Leveraging LC-MS and LC-MS/MS techniques, Alera Labs conducts in-depth analysis of drug substances and products. Our LC-MS/MS stability testing enables highly sensitive and specific detection and quantification of drugs, metabolites, and impurities, offering a comprehensive picture of product stability.
In addition to our core services, we also offer pharmaceutical LC-MS/MS stability testing, LC-MS/MS for in-process samples, and LC-MS/MS for finished product analysis. As a trusted LC-MS/MS service provider, we ensure top-tier analytical services, underlining our commitment to quality assurance and control.
Alera Labs provides an extensive range of stability testing services for the pharmaceutical industry. We are devoted to delivering reliable, accurate, and compliant results, reinforcing our reputation as a trusted contract lab for pharmaceutical analysis.
Extractables and leachables studies following ISO10993, Biocompatibility studies
Techniques used: HPLC, GC-MS, LC-MS, LC-MS/MS
The lab performs extractables and leachables studies following ISO10993 guidelines, providing valuable data on the compatibility and safety of medical devices and packaging materials.
Alera Labs offers comprehensive extractables and leachables studies in compliance with ISO10993 guidelines, ensuring the biocompatibility and safety of medical devices and packaging materials.
Our team employs advanced techniques like High-Performance Liquid Chromatography (HPLC), Gas Chromatography-Mass Spectrometry (GC-MS), Liquid Chromatography-Mass Spectrometry (LC-MS), Liquid Chromatography with tandem Mass Spectrometry (LC-MS/MS), to perform these studies, thereby delivering thorough, accurate, and reliable results.
The pharmaceutical HPLC analytical services at Alera Labs allow us to conduct comprehensive studies of extractable and leachable substances, providing crucial data about the chemical compounds that could potentially migrate from pharmaceutical packaging materials or medical devices.
With our Gas Chromatography extractables and leachables studies, we accurately identify and quantify volatile and semi-volatile compounds, supporting the safety and efficacy of your pharmaceutical products. Our status as a reliable GC service provider further enhances the credibility of our results.
Our LC-MS and LC-MS/MS analysis, employed in extractables and leachables studies, offer unparalleled sensitivity and selectivity in detecting, identifying, and quantifying extractable and leachable compounds. As an accredited LC-MS/MS testing lab, our services align with regulatory standards and ensure the highest degree of data accuracy.
Alera Labs stands as an ISO 17025 compliant lab offering a wide range of studies, including biocompatibility studies and extractables and leachables studies, supporting the pharmaceutical industry in maintaining product safety and regulatory compliance.
Method optimization, troubleshooting, and transfer
Techniques used: HPLC, GC-MS, LC-MS, LC-MS/MS
Alera Labs’ team excels in optimizing and troubleshooting analytical methods, enhancing their efficiency and effectiveness, and facilitating their transfer to different laboratories or manufacturing sites.
Alera Labs offers expert services in the optimization, troubleshooting, and transfer of analytical methods. By utilizing advanced techniques like High-Performance Liquid Chromatography (HPLC), Gas Chromatography-Mass Spectrometry (GC-MS), Liquid Chromatography-Mass Spectrometry (LC-MS), and Liquid Chromatography with tandem Mass Spectrometry (LC-MS/MS), we aim to increase efficiency and effectiveness, ultimately supporting seamless transfer to different laboratories or manufacturing sites.
Our pharmaceutical HPLC analytical services are central to our methodology optimization and troubleshooting efforts. As an experienced HPLC contract lab, Alera Labs is adept at tuning HPLC methods to enhance their performance, as well as diagnosing and addressing issues that can impede their operation.
Furthermore, our GC services are key to our method optimization and troubleshooting capabilities. As a trusted GC analytical lab, we specialize in fine-tuning GC methods for optimal performance, and rapidly resolving any operational problems that may arise.
Additionally, our expertise in LC-MS and LC-MS/MS plays a critical role in our method optimization, troubleshooting, and transfer services. As an LC-MS/MS contract lab, we have honed the skills necessary to adapt LC-MS/MS methods for maximum efficiency, swiftly identify and fix issues that may interfere with their function, and ensure successful transfer of these methods to other labs or manufacturing sites.
As an analytical service provider in the pharmaceutical domain, Alera Labs is committed to delivering optimized, problem-free analytical methods that can be easily transferred to different settings. Our method optimization, troubleshooting, and transfer services are testament to our dedication to our clients’ success. With Alera Labs as your partner, you can count on state-of-the-art techniques and industry-best practices to deliver reliable and efficient results.
Development, validation, and sample analysis for dose verification testing for GLP toxicology studies
Techniques used: HPLC, GC, LC-MS, LC-MS/MS
The company offers development, validation, and sample analysis services for dose verification testing in GLP toxicology studies, providing critical data for regulatory submissions.
Alera Labs specializes in the development, validation, and sample analysis for dose verification testing in toxicology studies. By leveraging cutting-edge techniques such as High-Performance Liquid Chromatography (HPLC), Gas Chromatography-Mass Spectrometry (GC-MS), Liquid Chromatography-Mass Spectrometry (LC-MS), and Liquid Chromatography with tandem Mass spectrometry (LC-MS/MS), we provide robust and reliable data that is crucial for regulatory submissions.
As a leader in HPLC analytical services, our expertise lies in the development and validation of HPLC methods for dose verification testing. As a trusted HPLC contract lab, we offer rigorous sample analysis services to ensure accurate data for GLP toxicology studies.
Our Gas Chromatography analytical services play a critical role in the development, validation, and sample analysis for dose verification testing. As a proficient GC contract lab, our focus is on delivering dependable results that can stand up to the strict scrutiny of GLP toxicology studies.
We also utilize LC-MS and LC-MS/MS in our services. As a well-respected LC-MS/MS contract lab, we focus on the development, validation, and sample analysis for dose verification, providing the critical data necessary for GLP toxicology studies and regulatory submissions.
Furthermore, we are also an analytical services provider for GLP toxicology studies, emphasizing the development and validation of analytical methods for dose verification testing. With our reliable sample analysis services, you can confidently use the data generated for your regulatory submissions.
With Alera Labs, you can trust us to deliver precise, reliable, and regulatory-compliant dose verification testing services for your GLP toxicology studies.
Development and validation of bioassays for pharmacokinetics studies
Techniques used: HPLC, LC-MS, LC-MS/MS
Alera Labs’ expertise includes the development and validation of bioassays to evaluate drug pharmacokinetics, aiding in the understanding of drug absorption, distribution, metabolism, and excretion.
Alera Labs, known for its extensive experience in the pharmaceutical industry, excels in the development and validation of bioassays for pharmacokinetics studies. Through our proficient use of sophisticated techniques such as High-Performance Liquid Chromatography (HPLC), Liquid Chromatography-Mass Spectrometry (LC-MS), and Liquid Chromatography tandem with Mass Spectrometry (LC-MS/MS), we offer comprehensive insights into drug absorption, distribution, metabolism, and excretion.
As a trusted HPLC contract lab, our skilled team contributes to the development and validation of HPLC methods for bioassays, aiding in pharmacokinetics studies. Our HPLC analytical services ensure accuracy and consistency, leading to reliable results.
Being a proficient LC-MS and LC-MS/MS contract lab, we stand out in the arena of pharmacokinetics studies. Our LC-MS/MS analytical services provide crucial insights into the process of drug absorption, distribution, metabolism, and excretion, vital to effective pharmacokinetics studies.
In the realm of bioassay development and validation, we offer services guided by precision and credibility. We focus on the development and validation of bioassays, ensuring a comprehensive understanding of drug pharmacokinetics.
Alera Labs offers high-quality LC-MS/MS bioanalytical services that form the cornerstone of effective pharmacokinetics studies. Our services in the field of LC-MS/MS metabolomics are aimed at understanding the intricate details of drug metabolism.
Alera Labs remains committed to providing high-quality, reliable, and accurate bioassay development and validation services for pharmacokinetics studies. Our advanced technological capabilities, coupled with our deep expertise, enable us to deliver dependable results that contribute to the success of your drug development endeavors.
Structure elucidation and Impurity Identification
Techniques used: HPLC, GC-MS, LC-MS, LC-MS/MS, FT-IR,
The company provides services for the elucidation of chemical structures and the identification of impurities, supporting the characterization and quality control of drug molecules.
In the pharmaceutical industry, Alera Labs stands as a trusted service provider for structure elucidation and impurity identification. Using state-of-the-art techniques including High-Performance Liquid Chromatography (HPLC), , Liquid Chromatography-Mass Spectrometry (LC-MS), Liquid Chromatography with tandem Mass Spectrometry (LC-MS/MS), Fourier Transform Infrared spectroscopy (FT-IR), and Gas Chromatography-Mass Spectrometry (GC-MS), we aid in the comprehensive characterization and quality control of drug molecules.
As an expert HPLC contract lab, we apply HPLC methods to facilitate structure elucidation and the identification of impurities. We provide HPLC analytical services for critical structure determination and quality control, ensuring a high level of accuracy in our assessments.
Similarly, as a competent LC-MS and LC-MS/MS contract lab, we utilize these techniques for detailed structure elucidation and impurity identification. Our LC-MS/MS analytical services are designed to uncover chemical structures and identify potential impurities that may affect the quality and efficacy of pharmaceutical products.
Our GC/MS services further contribute to our comprehensive offering. As a third-party GC/MS testing lab, we can precisely detect and identify various impurities, bolstering the safety and effectiveness of your drug products.
Our FT-IR services, often utilized in structure elucidation, allow us to provide further insights into the molecular composition of drug substances, complementing our other analytical techniques.
As a dedicated LC-MS/MS service provider, we pride ourselves on our ability to accurately identify impurities, helping ensure regulatory compliance and the highest quality of pharmaceutical products. Our dedication to quality assurance and control, combined with our technical expertise, makes us a preferred partner for structure elucidation and impurity identification in the pharmaceutical industry.
Formulation development for various drug products (tablets, gels, etc.)
Techniques used: HPLC, GC-MS, LC-MS, LC-MS/MS
Alera Labs’ capabilities extend to formulation development for various drug products such as tablets and gels, tailoring formulations to meet specific requirements and optimize their performance.
Alera Labs excels in delivering tailored analytical chemistry services with a particular emphasis on the pharmaceutical industry. Our dedicated and experienced team prides itself on its proficiency in a broad spectrum of compounds and techniques. This expertise encompasses pharmaceutical compounds, drug metabolites, impurities, degradants, environmental contaminants, and biological materials.
In our well-equipped laboratory, we utilize an array of fully qualified analytical instruments, including High-Performance Liquid Chromatography (HPLC), Gas Chromatography (GC), and Liquid Chromatography-Mass Spectrometry (LC-MS), and Liquid Chromatography with tandem Mass Spectrometry (LC-MS/MS). These state-of-the-art techniques bolster our capacity to develop and optimize formulations for a variety of drug products such as tablets and gels, tailoring them to meet specific requirements.
Being a proficient HPLC, GC, LC-MS, and LC-MS/MS contract lab, we leverage these techniques to analyze, validate, and ensure the highest quality of the formulations we develop. Our services extend to contract research organizations, for which we are capable of delivering a range of optimized drug product formulations that meet necessary performance and quality standards.
Each piece of data generated in our lab undergoes multiple levels of review and a thorough Quality Assurance audit before being delivered to our clients. In this way, we ensure the highest reliability and accuracy of our data.
At Alera Labs, despite our small size, our emphasis on superior science, exceptional customer service, and meticulous attention to detail sets us apart. We consider every project, regardless of its size, a top priority and aim to meet, and often exceed, our clients’ needs and timelines. As a result, we have become a trusted partner for many in the pharmaceutical industry, known for delivering reliable and high-quality formulation development services.
Studies involving controlled drug substances
Techniques used: HPLC, GC, LC-MS, LC-MS/MS
Alera Labs conducts studies involving controlled drug substances, ensuring compliance with regulatory requirements and guidelines and assisting in the safe and effective use of these substances.
Alera Lab offers laboratory services tailored to the pharmaceutical industry. We provide a range of analytical chemistry services, including testing and analysis of drug substances, active pharmaceutical ingredients (APIs), intermediates, drug products, and finished dose forms. These services may encompass method development, method validation, stability testing, impurity identification, analysis of raw materials and excipients, and compliance with regulatory standards.
As a specialized analytical chemistry service provider based in North Carolina, Alera Labs showcases proficiency in conducting studies involving controlled drug substances. Utilizing advanced techniques such as High-Performance Liquid Chromatography (HPLC), Gas Chromatography-Mass Spectrometry (GC-MS), and Liquid Chromatography-Mass Spectrometry (LC-MS), and Liquid Chromatography with tandem Mass Spectrometry (LC-MS/MS), Alera Labs facilitates accurate testing and comprehensive analyses, establishing itself as a critical player in the North Carolina pharmaceutical landscape.
Alera Labs’ emphasis on regulatory compliance underpins its suite of laboratory services, as it ensures adherence to stringent guidelines in the analysis of drug substances and products. By providing dependable and timely support, the team contributes effectively to the safe and efficient use of these substances.
As a reputable provider of pharmaceutical analysis services, Alera Labs excels in analyzing Active Pharmaceutical Ingredients (APIs), delivering precise testing results that contribute to maintaining the highest quality standards in drug development and production. Our expertise extends to stability testing and impurity identification, essential components of pharmaceutical quality control.
Alera Labs’ adeptness in raw material and excipient analysis complements its wide range of services, providing comprehensive insights into all components of pharmaceutical products.
The distinct blend of Alera Labs’ robust capabilities and client-focused approach places it at the forefront of supporting the pharmaceutical industry’s rigorous demands in North Carolina.