Analytical Testing

Scientech has the expertise to provide a wide array of testing services:

  • USP/NF Testing
  • API
  • Raw Material
  • Dissolution
  • Disintegration
  • Content Uniformity
  • Identification (HPLC, GC, UV/VIS, FTIR)
  • Residual Solvents
  • Heavy Metals
  • Impurities
  • Organic Volatile Impurities

Product Types

Scientech has extensive experience testing the following product types:

  • Tablets and capsules
  • Liquids and gels
  • Suspensions
  • Topicals
  • Ointments
  • Creams and lotions
  • Balms
  • Foundations
  • Powders (including medicated)
  • Aerosols
  • Sprays

Stability Studies

Scientech has extensive experience conducting stability studies. We have a number of chambers designed to address all your stability needs.

Available Storage Conditions

  • Ambient or room temperature storage at 25C and 60% RH.
  • Accelerated storage at 40C and 75% RH.
  • ICH storage.
  • Super accelerated storage.

Reliable

  • Our stability chambers are continuously monitored to ensure the integrity and reliability of your stability data.

Accurate

  • We establish a stability schedule to identify all the due dates for each test interval.
  • Each sample is pulled on its due date and testing is performed in strict conformity with the approved schedule.

Flexible

  • We offer a “Storage Only” solution and will send your stability sample on its due date to a testing facility of your choice.
  • We do not charge cancellation fees for the termination of a stability study.

Method Development and Validation, Verification and Transfer

Scientech has extensive experience developing and validating analytical methods in accordance with FDA and ICH (Q2/R1) Guidelines.

We use the following characteristics to validate:

  • Specificity
  • Linearity
  • Accuracy
  • Precision
  • Repeatability
  • Intermediate Precision
  • Reproducibility
  • Range
  • Quantitation limit
  • Detection limit
  • Robustness

Scientech has extensive experience with methods verification.

  • Suitability of compendial methods (e.g., USP/NF and AOAC) during actual conditions of use.

Scientech has extensive experience with methods transfer. We work closely with you to understand your needs and objectives, and we tailor our solution to achieve your goals.

107-G Corporate Blvd., South Plainfield, NJ

info@scientechlabs.us

908-561-6330