Daicel Chiral Technologies India (DCTI) offers analytical services for pharmaceutical industry from our cGMP compliance lab equipped with state of the art instrumentation with network software to meet the requirements of 21 CFR Part 11. The facility is certified according to ISO 9001:2008 standards and self-identified with US-FDA. DCTI has a dedicated team of experienced analytical scientists and a quality assurance team to ensure adherence to the customer’s protocol.
Analytical Method Development and Validation
DCTI provides method development for intermediates, APIs and finished products. DCTI’s expertise is to develop reliable analytical methods to suit the intended purpose. Method development covers solution stability and system suitability for the analysis of related substances, assay, dissolution for finished products. DCTI works closely with our clients to deliver robust, efficient and stability-indicating methods while ensuring minimal method development time. DCTI is equipped with the latest chromatographic technologies such as UPLC to develop rapid methods. DCTI also offers method verification through design of experiments (DOE).
Further, method validations are carried out as per current ICH guidelines or as per customer-defined protocols. Data integrity is ensured by use of Waters Empower™ network software, which fulfills the regulatory requirements. The data can be used to prepare technical documents for various regulatory submissions.
Method development and validation are completed for:
- Related substance by HPLC / UPLC
- Assay by HPLC / UPLC
- Residual solvents by GC-HS-FID
- Enantiomeric impurity by HPLC / UPLC
- Dissolution by HPLC / UV
- Non-carry over studies by LC-MS
- Forced degradation studies by HPLC / UPLC
Impurity isolation by preparative HPLC/SFC
According to the regulations, any unknown impurity > 0.1% in the drug substance / drug product needs to be characterized. Standard approach is to proceed for characterization after isolation of impurities through preparative chromatography. Further, preparative chromatography may also be used to isolate the impurities difficult to synthesize. Daicel’s new-generation immobilized chiral columns have simplified the impurity isolation process. At DCTI, we routinely perform impurity isolation tasks using our immobilized chiral stationary phases on prep LC / SFC. The universal solvent compatibility of our versatile immobilized chiral phases allows rapid turnaround time and a high success rate to exceed customer expectations. DCTI’s impurity isolation team has rich experience in isolating the impurities from 0.1% level to achieve >95% purity.