2007 FDA INSPECTION
QCL is pleased to announce the results of our latest FDA inspection. This PAI/GMP inspection was conducted on November 5 and 6, 2007, and no FDA Form 483 citations were issued. This was QCL’s fourth FDA inspection since inception in 1998 and no Form 483 citations have been issued to date.

Announcing Expanded Pharmaceutical Stability Services
Quality Chemical Laboratories is pleased to announce the expansion of our current stability storage facility. Over the past year capacity has increased 10 fold with the addition of several walk in rooms. In addition to the increased storage capacity we continue to offer the following as part of our Pharmaceutical Stability Services:

Storage Conditions with Over 2000 ft3 of Capacity

ICH:

• 25°C/60%RH
• 30°C/65%RH
• 40°C/75%RH
• 5°C
• -20°C
• Photostability (Option 2)

• Climatic Zones III and IV conditions
• 25°C/40%RH
• Ambient Storage
• Thermal Cycling
• Freeze/Thaw studies

• Kaye Labwatch Monitoring and Alarm Notification System
  • 21 CFR Part 11 Compliant Audit Trail
  • MKT Calculation and Customizable Reports
• Generator Back Up

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.

QCL announces the addition of Time-of-Flight LC-MS technology
Quality Chemical Laboratories is pleased to announce the addition of Time-of-Flight LC-MS technology to our broad range of analytical services. This state of the art LC-MS instrument combines high chromatographic and high mass resolution, with great sensitivity, allowing QCL to provide comprehensive material characterization information to the pharmaceutical industry.

Applications:

• Structural Identification
• Identification of process impurities
• Identification of stability-induced impurities
• Peak purity assessment in method validation studies
• Product de-formulation
• Extractables & leachables testing

Now Available
Quality Chemical Laboratories is now offering GMP Microbiology services for pharmaceutical products and raw materials. Please visit our sevices section for more details. Contact us for your microbiology needs.

View our Microbiology Services

2008 Trade Shows