Pharmaceutical Lab Testing Services In New Hampshire
Boston Analytical offers an array of pharmaceutical testing, sampling, and validation services at its headquarters in Salem, New Hampshire. The primary pharmaceutical testing services offered include:
- Analytical Development & Validation
- Analytical Testing
- Microbiology Testing
- Extractables & Leachables
- Nitrosamines and Impurities Testing
- Stability Testing
- Raw Materials Testing
- Managed Services
As a customer-centric pharmaceutical analysis lab, we offer an all-encompassing solution, including sampling, testing, analysis, and managed services for many industries throughout the region.
14 Manor Parkway
Salem, NH 03079
Full-Service Sampling, Analytical Testing, and Validation
Boston Analytical’s headquarters serve New Hampshire and the entire region. We offer comprehensive sampling and testing solutions designed for the stringent requirements of the pharmaceutical, biopharmaceutical, and medical device industries, as well as manufacturing and consumer products. Our testing and validation services are designed to aid you in the CMC (chemistry, manufacturing, and controls) stages and why we are considered the most reliable facility among many pharmaceutical testing companies.
We understand the time-critical needs and strict quality requirements for testing, analyzing, and validating new chemical or organic drug formulations. We can measure, analyze, and test the efficacy, strength, and potency of new drugs while helping narrow down the proper dosage so it’s safe long before its introduction to consumers.
- Dissolution testing
- Over 25 years of experience in pharmaceutical dissolution analysis
- Multiple dissolution apparatuses, apparatus IV instruments, and HPLC systems
- In-process & lot release testing
- Immediate scheduling, detailed documentation, and fast turnaround times
- Raw material testing
- USP, BP, EP, and JP raw materials identity testing
- Product characterization
- Both physical and chemical
- DSC, TGA, XRPD, FTIR, PSD analysis, metals testing (ICP-MS), atomic absorption (AA), etc.
We know how important it is to have an independent third-party testing facility validate findings and offer time-critical data at every stage of that all-important product development journey. The faster we provide results and the more accurate the data, the quicker you can complete your filings and reduce your product-to-market lead times.
For medical device manufacturers, we perform bioburden and bacterial endotoxin testing and validation to ensure your medical devices have no sterility issues.
- Microbiome / Live BioTherapeutics Products
- Multiple microbiome programs, including spore fraction and defined drug product manufacturing processes
- Microbial identification
- MALDI-TOF mass spectrometer and Roche LightCycler® for microbial identification
- 3130XL Genetic Analyzer or the Bruker Biotyper® MALDI-TOF system for microbial contamination
- Bacterial endotoxin testing
- We follow USP/EP guidelines using Gel clot, kinetic chromogenic, and turbidimetric methods
- Biological indicator testing
- All USP <55> compliant methods are followed
- In vitro microbial kill rate studies
- Test customer-supplied bacteria and fungi and those listed in USP <51>
- Sterility testing <71>
- VHP Isolator technology
- USP <61> and <62>
- Environmental Monitoring and Critical Utilities Services
- Protocol design and writing
- Sampling services
- Analysis and Data Trending
- Purified Water Sampling and Analysis
- Compressed Gas Sampling and Analysis
Additional services include method development, consulting, protocol writing, and managed service contracts with remote lab technicians working on-site at your facility.
Boston Analytical runs the following laboratory-focused software to ensure our customers have the most up-to-date and accurate results.
- LabWare LIMS™ (Laboratory Information Management System)
- LabWare ELN™ (Electronic Laboratory Notebook)
- Environmental Monitoring Software
Data-Driven Results With Boston Analytical
As a cGMP-compliant, FDA/DEA-registered, ISO/IEC-17025:2017-certified pharmaceutical testing lab, Boston Analytical uses the latest and most sophisticated analytical testing equipment and state-of-the-art delivery and information technology systems. Our Salem headquarters is near Boston and easily accessible.
Every member of the Boston Analytical team is devoted to providing you with the essential data you need to make go/no-go decisions at every stage of your product’s journey. Our focus is simple — provide accurate, timely data backed by consistent, proven, and reliable test methods and the most accurate testing equipment available.
If you would like to work with a forward-thinking, data-driven pharmaceutical testing partner, contact us now.