Chemistry Capabilities
Pharmaceutical Stability Testing – MAL has expertise in conducting stability studies for finished dosage forms. We have tested the following dosage forms: liquids, suspensions, tablets, capsules, and gel capsules. We have the capability of storing and analyzing products for H2 and H4 conditions. The typical tests that are requested for stability testing are the following: Assay, Dissolution, and Related Compounds. Other test that are requested for various dosage forms are appearance, preservative content, alcohol content, friability, disintegration time, and content uniformity.
Pharmaceutical Release Testing – We perform finished goods testing as needed for our customers. The finished goods testing is expedited to meet stringent time requirements.
All customer methods undergo a method technology transfer into our laboratory prior to analyzing samples. This method can follow either a customer Method Technology Transfer (MTT) protocol or our internal procedure for MTT or Method Verification.
We conduct Method Verifications for all USP test methods prior to analyzing samples for the first time.
Method Technology Transfer and Method Verification reports are sent to the customer following the MTT or Method Verification.
Instrumentation
Waters Alliance HPLC Systems (19 with UV/VIS Detectors) 2 with Photo Diode Array Detectors (PDA), and 1 with Refractive Index Detector (RI).
Waters Acquity H Class Systems (4 with TUV Detectors) 1 with PDA
Waters Modular HPLC Systems (5 with Dual λ Absorbance Detectors), 1 with RI.
Agilent 7890B GC with Dual FID detectors and (Packed and Capillary column capability)
Perkin Elmer AAnalyst 200 Atomic Absorption Spectrometer
1 Agilent Cary 60 UV-VIS Spectrometer
1 Agilent Cary 630 FTIR Spectrometer
1 Agilent Cary Eclipse Fluorescence Spectrometer
6 Hanson SR8 Plus Dissolution Apparatus
2 Hanson Vison 8 Elite Dissolution Apparatus
1 Hanson Vision AutoPlus Autosampler
1 Agilent BIO-DIS Reciprocating Cylinder Apparatus
3 Agilent 708 DS Dissolution Apparatus
1 Q-Sun Xenon Test Chamber
1 HotPack Stability Chamber 25oC and 60% Relative Humidity (RH)
1 HotPack Stability Chamber40oC and 75% RH
