OUR CAPABILITIES AND COMPETENCIES
Whether your analytical needs are in support of manufacturing or solely for stability purposes, PMRS has the resources to accommodate your project. We offer:
- Fully Electronic, Paperless Documentation
- Method Development and Validation
- Raw Materials Testing
- Release Testing
- ICP-MS Testing
- X-Ray Particle Diffraction Testing
- Onsite Stability Study storage and testing
- Stability Environmental Chambers
- ICH compliant
- Continuously monitored to deliver real-time alerts for out-of-specification conditions
- Chambers are backed up with emergency power to ensure the quality of your study
We work with our clients to set up and execute stability projects based on their unique specifications. All projects are tracked via LabWare LIMS to ensure that testing is performed on time. All samples are tested within 2 weeks of the pull date for every time point. Stability CoAs containing all data are generated, Quality reviewed, and submitted to the client within 1 month of the pull date. Whether you need dedicated or individual projects, PMRS is committed to providing the highest quality and speed to reduce overall project costs.
- ICP-MS
- Rapid Resolution Liquid Chromatography
- Diode Array detection
- High Performance Liquid Chromatography
- UV/VIS detection
- Diode Array detection
- Total Organic Carbon Analyzer
- UV/VIS Spectrophotometer
- Dissolution Apparatus
- USP <711> Apparatus 1 and 2
- 1 and 2 liter vessel configurations
- Stability Environmental Chambers/ ICH Compliant Stability Chambers
- 5°C
- 25°C/60%RH
- 30°C/65%RH
- 30°C/75%RH
- 40°C/75%RH
- -20°C
- Photostability
- Glove Box for High Potency (OEL Band 4) Compounds
- Karl Fisher Coulometer with Oven Sample Processor
- Potentiometric Karl Fisher
- FTIR Spectrophotometer
- pH meters
- Centrifuges
- Balances
- Viscometer
- Gas Chromatography
- FID Detection
- Headspace and direct injection
- Polarimeter
- Melting Point Apparatus
- Refractometer
Method Development and Validation
Since our founding in 1994, PMRS has validated hundreds of analytical methods in various product formulations. From tablets and capsules to creams and extrusions, we will work closely with you to achieve superior quality for the lowest cost.
Our methods are:
- Developed and validated according to either specific client requirements or our own extensive Standard Operating Procedure.
- Validated in compliance with FDA and ICH guidelines.
We also provide development of residual cleaning verification methods:
- We develop and optimize residual cleaning verification methods for all active pharmaceutical ingredients and cleaning agents.
- We analyze and verify the cleanliness of all major equipment after every manufacturing campaign.
- We evaluate active and cleaning agent cleanliness to ensure the highest quality and purity for all products.
Raw Materials
Our Raw Materials laboratory is equipped with expert staff and state-of-the-art equipment to perform full USP/EP/JP testing of excipients, APIs, and packaging components. We have the resources to source, purchase, and quickly release materials using automated technology (such as Near-IR), thereby accelerating project timelines and reducing project costs.
Release Testing
At PMRS, we pride ourselves on providing the fastest services and highest quality products for the lowest cost. We are pleased to offer services that others cannot and are always looking toward the future, investing in cutting edge technology, systems, and experts in order to bring our clients the best service in the industry.
- We can work with DEA Scheduled I-V Controlled Substances
- We have the capability and knowledge to test various formulation products
We offer:
- Extensive analytical support for release testing
- Talented, experienced staff to perform release testing on in-process products as well as finished dosage forms
- Rapid Resolution Liquid Chromatography using the cutting-edge Agilent 1290
- Dissolution Apparatus with autosamplers
- A steady supply of new technology to provide clients with the highest quality analytical data
Microbiological Services
From method validation to finished product testing, our fully cGMP compliant Microbiological Services Laboratory routinely supports a wide range of services. All testing is performed on-site, which facilitates an extremely fast turnaround time. Our experienced staff ensures that all product quality requirements are met.
Our capabilities include:
- Full support of the Manufacturing Services:
- Purified water
- Environmental monitoring
- Compressed air monitoring
- Microbial Enumeration Preparatory Testing and Microbial Enumeration Testing conforming to the USP/NF, EP, and JP
- Antimicrobial (Preservative) Effectiveness Testing
- Bioburden evaluation of product containers