Analytical Method Development and Quality Control

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• One-stop analysis/stability/CMC services for IND/CTA, NDA/MAA and ANDA filings
  High-quality, fast and low-cost one-stop servicesOne-stop services for drug analysis, research and development, stability, quality control, and CMC regulatory documentsApplicable to domestic and overseas filings

Method development and methodology verification

• Various chromatographic techniques (HPLC, UPLC, GC, and IC) and detection techniques (UV, MS, MS/MS, ELSD, FID, fluorescence, etc.) to assess different types of compound Analytical and detective methods of contents and/or related substances for stability study on API and pharmaceutical preparations (tablets, capsules/liquid capsules, liquid preparations/emulsions, powder preparations, pills/coated pills, injections, topical drugs, solid dispersants, etc.)Special detection methods, such as dissolution (IR, ER and MR), solvent residue, genotoxic impurities, enantiomeric separation, ion chromatography and microbiological test.Experimental design in method development, progress reports, method verification schemes and verification reports, and drug analysis methodsCorresponding solutions for each stage of IND/CTA or NDA/MAA filings
  Medicilon has a GMP labs for release inspections, analytical method verification, and stability studies.

Analytical, testing and release

• Analytical support for drug R&D and cleaning verificationCoA calibrated by reference materials or complete standard reportsDetections of compound structure and configuration confirmationStructural identification of impurities or degradation products by LC/MS/MS and various nuclear magnetic resonance spectroscopyDetermination of degradation pathway and provision of filing materialsLeachable/extractable detections

Stability study

• Stability tests supporting global drug registrations; experimental/exploratory stability (pre-experiment); and stability tests of drugs after approval for market Integrated services includingscheme design, project management, stability sample storage and testing, data trend analysis, drug shelf-life evaluation, and NDA/MAA filing and document preparationStorage conditions: 40°C/75%RH, 30°C/75%RH, 30°C/65%RH, 25°C/60%RH, with proper lighting, or customer-defined storage conditions, including 2-8°C, -20°C, -70°C, 25/40, 30/35, 40/20 and 50/40 (new)Constant temperature and humidity boxes (IQ/OQ/PQ certified) for stability study; multi-channel power supply; real-time temperature and humidity monitoring (dual system); and an automatic alarm system

Relevant laboratories

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