State-of-the-Art R&D Laboratory
State-of-the-Art Research and Development Laboratory
Our state-of-the-art laboratory gives us the capabilities of being able to support our manufacturing operations , especially for validating all products that we currently manufacture at our USA facility. Some of the types of testing that we conduct during the various phases of product development and manufacturing includes Identification & Assay, Content Uniformity, Dissolution, Disintegration, Stability Studies, Microbial Testing, Method Validations & Feasibility Studies, Specifications of API’s & Excipients, Flavor and Color Testing, Residual Solvents, Drug Substance and Excipient Testing, Compatibility Studies and more.
Quality Control & Analytical Supporting Services
At PharmaTech LLC, one of our top priorities is delivering a quality turnkey service. Maintaining our own research and development laboratory allows us to offer quicker tunrarounds on both product development and manufacturing services. Moreover, all products are released with their appropriate certificate of analysis showing a variety of test results. In addition, we assure that all products manufactured within our facility are either in process to be validated or completely validated, meaning we do business being FDA compliant while implementing Current Good Manufacturing Practices. Below are some of the testing and equipments we have on hand at our FDA inspected and approved, Schedules 1-5 laboratory:
Raw Material Testing
- Identification
- Assay
Finished Product Testing
- Assay
- Content Uniformity
- Dissolution and Disintegration
- Uniformity of Dosage
- PH
- Microbial Testing
- Nutritional Fact Testing
Other Product Testing
- Optical Rotation
- LOD
- Distillation
- PH
- Chemical Solvent Residue
- Sulfur Dioxide
- Viscometer and Arsenic
- Hardness Testing
- Heavy Metals
- Friability and Density Testing
Wet Chemistry Analysis
Wet chemistry analysis is used for quantitative chemical measurements, such as changes in colormetrics but often involves more quantitative chemical measurements using methods such as titrimetric. Many of these procedures provide valuable information that cannot be duplicated by modern instrumentation. PharmaTech LLC has equipment, knowledge and experience that enables us to provide different wet chemical analysis. This total commitment requires us to maintain an inventory of reagents, volumetric solutions, glassware and indicators.
- Karl Fisher Titration
- Residue on Ignition
- PH (Acidity, Alkalinity)
- Loss on Drying
- Distillation
- Arsenic
- Heavy Metals
- Concentration
- Limit Test
- Melting Range
- Color Testing
- Selenium
- Osmolality
- Chromatographic Purity
- Sulfur Dioxide
- Torch Tester
- Thin Layer Chromatography
- Viscometer
- Conductivity
- Identification
- Residual Solvents
Compendia Testing
PharmaTech LLC perform s a vast array of compendia testing. These include:
- USP/NF
- EP
- JP
- BP
- FCC
- JPE
- ACS
- AOAC
- AOCS
- ASTM
Alternative methods to compendia procedures are frequently required. They can be supplied by our clients or their vendors. Many times we will develop new methods or perform cross validations.
Instrumental Analysis
Instrumental Analysis are used for a variety of tests ranging from measuring impurities in raw materials to the determination of purities in finished products. PharmaTech LLC is equipped with the necessary instrumentation to meet testing needs. Some of these are listed below:
HPLC
UV/VI
DAD
RID
Fluorescence
Dissolution Baths
GC (Automated Head Space Sampler, FID, TCD, ECD)
Atomic Absorption
UV-Vis Spectrophotometer
Infrared Absorption
Moisture (Karl Fisher Titration)
Total Organic Carbon
Tablet Hardness
Friability Tester
Density Tester
Hardness Tester
Balances
Microbial Services
- STERILITY
- Biological Indicator Testing
Environmental Monitoring
- Airborne Particulates
- Surface Testing
- Viable and Non-Viable Airborne Microbes
- Compressed Air Testing
- Water Testing
Microbial Testing
- Efficacy Testing
- Total Plate Count
- Yeast and Mold
- Salmonella
- E. Coli
- S. Aureus
