SERVICES

Pharmaceutial Product QC

Pharmaceutial Product QC

Drug Testing & Inspection Service

The Caleb Multilab Inc., has been approved as a drug testing and inspection agency from the Ministry of Food and Drug Safety (MFDS) since 2015. We provide several services of testing and inspection items using LC-MS/MS, HPLC and UV. We also can perform method development and comparative dissolution test.

We set up an audit trail system and perform the requested test according to the pharmaceutical affair law, guidelines and our standard operation procedure for increasing reliability.

Testing and inspection items
  Group Items Instrument
1 Oral solid preparation
(Tablet, Hard capsule)
Content uniformity test HPLC
2 Dissolution (Apparatus 1 & 2) HPLC, UV
3 Impurity test LC-MS/MS
4 Liquid preparation
(Soft capsule)
Assay HPLC
5 Dissolution (Apparatus 3) HPLC
6 Injections Impurity test HPLC
Process
  • STEP 1 : Test application and contract
  • STEP 2 : Receive sample
  • STEP 3 : System suitability or method validation
  • STEP 4 : Progress test
  • STEP 5 : Provide certificate or report