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Method Development and Validation
QCL offers analytical method development and validation services for Active Pharmaceutical Ingredients (APIs), Drug Production Formulations, cleaning agents used in manufacturing processes, and raw materials/excipients. The dedicated group of chemists that perform these studies have many years of experience in such disciplines as HPLC,  GC, ICP, AA and Dissolution. All method validations are performed under cGMP requirements and meet the current ICH and FDA guidelines.

Raw Materials Analysis
QCL offers a 10-day turnaround time on all raw materials testing. This applies to USP, EP, JP, BP, FCC, ACS, and client-supplied methods. For all compendial purified water testing, QCL offers a 5-business day turnaround time. QCL's dedicated group of experienced chemists allows us to offer this exceptional turnaround time. All documentation is extremely detailed, and fully GMP reviewed at test completion. Because of the stringent checks and balances between the laboratory and the Quality Assurance Group, all final results are guaranteed to be accurate and reliable.

Stability Storage and Testing
QCL offers stability storage and testing as part of our stability management services for drugs substances and drug products from development to market.  Our experienced team of chemists allows us to offer development/validation of stability indicating methods, forced degradation studies, impurity/degradant characterization, in addition to routine analytical and microbiological testing.  QCL can completely manage your study from start to finish beginning with protocol creation and management and ending with data evaluation including stability summary tables (FDA format or custom), data trending, and expiration date prediction.  With our recent expansion QCL has all of the typical ICH storage conditions available (25°C/60%RH, 30°C/65%RH, 40°C/75%RH, 5°C, -20°C, Photostability (Option 2)).  Ask about our other capabilities including: climatic zones III and IV storage, 25°C/40%RH for semi-permeable containers, thermal cycling, and freeze/thaw studies.  All conditions are continuously monitored by the Kaye Labwatch Facilities Monitoring and Alarm Notification System and is equipped with a natural gas generator for power backup.

Trace-metals Analysis
QCL performs routine testing, as well as method development and validation, for the assay of metallurgic impurities in raw materials and finished products. QCL has the capability to simultaneously scan for trace levels of any metal contaminant. Some of the support instrumentation includes ICP and AA (equipped for flame, cold vapor, and graphite furnace technologies). The ICP has the capability to scan for up to 72 metals in less than three minutes. The spectrometry group has extensive experience with all facets of ICP and AA analyses.

Dissolution Testing
QCL offers dissolution testing to support finished product analyses, as well as method development/validation of dissolution methods. The dissolution apparatuses are equipped for USP Apparatus 1 and 2 testing. Development/validation experience includes work with intrinsic disso techniques utilizing the Wood's apparatus to obtain active profiles, profiles of creams with VanKel enhancer cells, time-release capsules and dual active formulations.

Organic Synthesis
QCL employs a group of experienced chemists dedicated to performing small-scale custom chemical synthesis (non-GMP) utilizing a wide selection of chemistry.  QCL routinely carries out contract synthesis of pharmaceuticals/agrichemicals and their intermediates, specialty chemicals, reference/analytical standards and metabolites.  The group specializes in performing multi-step synthesis, especially those demanding strictly anhydrous reaction conditions while using highly pyrophoric organometallic reagents.  The process development group has the expertise to help our clients in evaluation/improvement of existing processes or in developing a new and more economic synthetic route.  Other services available include API production, isolation, and purification, and drug substance characterization.

Specialty Services
QCL offers specialty services that are tailored to the client's specific needs. In addition, QCL offers a wide range of non-routine testing services to the pharmaceutical and medical-related industries. Examples of these services include process validation, intrinsic dissolution, and degradation product characterization.

Microbiological Testing
QCL offers microbiological testing of raw materials, intermediates and finished products. The testing applies to USP, EP, JP, BP, FCC and client supplied methods. The laboratory is equipped with state of the art equipment such as a qualified autoclave, temperature mapped incubators and HEPA supplied biological safety cabinets. Services offered are:

  • Microbial Limits/Bioburden/Water Testing
  • Endotoxin testing (LAL)
  • Disinfectant Qualification
  • Antimicrobial Preservative Effectiveness Testing
  • Cleaning Validation Support
  • Method Validation