Industry Served
Pharmaceutical
API
Raw Materials
Dietary Supplement/OTC
Consumer Goods
Analytical Services
At PLS Analytical, raw material, in-process material and product quality as well as cGMP compliance are of the highest importance when manufacturing nutritional and dietary supplement products for our customers. We are committed to formulate and manufacture the safest and most effective Nutraceutical & dietary supplements for our customers and partners by:
- Conducting Formulation Studies, Stabilities Studies and Product Development Testing in our in-house and on-site Product Development Lab.
- Testing the quality of our raw materials and products in our on-site, state-of-the-art laboratories. Our experienced scientists test the identity, purity, strength, composition, and limit of contaminants in raw materials and products QC labs.
- PLS Analytical’s laboratories house some of the most advanced equipment for product development and QC testing.
Following is the glimpse of the lab equipments in Our QC Lab:
Oral Solid QC Testing Instruments
Oral Liquid QC Testing Instruments
Oral Spray QC Testing Instruments
Gas Chromatography with Head Space
HPLC Instruments with UV/ELSD/RI detectors
ICP-MS
UV – VIS Spectrophotometers
FTIR Spectrophotometers
Stability Chambers
Polarimeter – Purity Identification for Amino Acids
Submit a quote request or call (732) 698-5048 today for a consultation with our management team.
ANDA Development
Active
Inactive Pharmaceutical Ingredient & Excipient Testing
Cleaning Validations
Product Development
Sourcing of Active Pharmaceutical Ingredients & Excipients
Product marketability Evolution
Pilot Batch Manufacturing and Stability Evaluation Bioequivalence Studies
Performance Monitoring Report
Compiling and Electronic Submission of ANDA (e-CTD format) Pre-marketing process validation
Elemental Impurities
PLS Analytical can analyze for elemental impurities using a Shimadzu ICP-MS Model 2030:
- Finished Drug Products
Raw Materials
Nutritional Supplements
Topical Products
- California Proposition 65
USP <232> <233>
Nasal InVitro Bioequivalence Testing
PLS Analytical has the availability to perform InVitro Bioequivalency Studies:
- Single Actuation Content (SAC) Through
- Container
- Life
- Droplet Size
- Drug Small Particles
- Plume Geometry
- Priming and Repriming
Microbiology
- Extractable and Leachable Evaluations
- Method Development and Validation
- Method Development & Validation for Leachable Studies
Full Time Equivalent (FTE) Program
Achieve Project Goals
- Work Flexibility
- Manage & Control Costs
Increased Productivity
Short Term or Long Term
cGMP Trained Personnel
Program can be Either Insourcing or Outsourcing
Stability Storage and Testing
The purpose of stability testing is to provide evidence on how the quality of a drug substance or drug product varies with time under the influence of a variety of environmental factors, such as temperature, humidity, and light, and to establish a retest period for the drug substance or a shelf life for the drug product and recommended storage conditions.
Method Development, Validation and Transfer
Analytical methods development and validation play important roles in the discovery, development and Manufacture of pharmaceuticals. Method development is the process of proving that an analytical method is acceptable for use to measure the concentration of an API in a specific compounded dosage form which allow simplified procedures to be employed to verify that an analysis procedure, accurately and consistently will deliver a reliable measurement of an active ingredient in a compounded preparation. The analytical method validation is essential for analytical method development and tested extensively for specificity, linearity, accuracy, precision, range, detection limit, quantization limit, and robustness. In summary, analytical method development and validation allows to confirm that an accurate and reliable potency measurement of a pharmaceutical preparation can be performed.
