ODM HPLC Manufacturer & Manufacturers: Precision Botanical Analytics & Industrial Scale CDMO

Our HPLC analytical development protocols strictly follow ICH Q2(R2) and USP <1225> guidelines. Each comprehensive analytical dossier includes:
• Specificity & Selectivity: Full baseline resolution (Rs > 1.5) separating the analyte from matrix co-eluting peaks, degradants, and solvent blanks verified by PDA peak purity curves and MS spectral verification.
• Linearity & Dynamic Range: Minimum 5-point calibration curves with correlation coefficients (R²) exceeding 0.999 across 50% to 150% of the target formulation concentration.
• Accuracy & Recovery: Standard recovery testing at low, mid, and high concentrations (typically 80%, 100%, and 120%), with acceptable mean recoveries bounded between 98.0% and 102.0%.
• Precision (Repeatability & Intermediate Precision): Six replicate sample injections evaluated by different analysts on distinct days and columns, holding relative standard deviations (%RSD) below 2.0%.
• LOD / LOQ: Determined by signal-to-noise ratios (S/N ≥ 3:1 for Limit of Detection; S/N ≥ 10:1 for Limit of Quantitation).
• Robustness: Systematic variation of column temperature (±5°C), flow rate (±0.1 mL/min), and mobile phase organic composition (±2%) to verify method resilience during global analytical site transfer.

Botanical matrices exhibit natural variations driven by altitude, microclimate, soil minerals, and seasonal harvest timing. We resolve this challenge through our systematic Origin & Seasonal Potency Evaluation Matrix. By deploying chromatographic fingerprinting (SF similarity evaluations against authentic reference standard libraries), we identify the optimal geographical source and harvest window. In pilot-scale and commercial extraction, we standardize intermediate batches by blending certified lots to target a defined active percentage (e.g., total ginsenosides ≥ 80.0%, chlorogenic acid ≥ 50.0%), eliminating inter-lot variability for downstream capsule or tablet stability.

Yes. MedGence bridges the traditional gap between pure contract research laboratories and industrial manufacturing plants. Our pilot facilities and directly managed manufacturing plants handle:
1. Active Ingredient Bulk Supply (OEM): Purified botanical powders, concentrated aqueous/hydroalcoholic extracts, high-purity crystalline active isolates, and vacuum-distilled volatile essential oils.
2. Finished Product CDMO: Turn-key conversion into solid dosage forms (coated tablets, enteric capsules, softgels), oral liquids, sachets, and effervescent botanical drink matrices packaged under clean cGMP environments.

We provide complete Common Technical Document (CTD) Module 3 (Quality/CMC) files alongside Module 4 (Nonclinical Study Reports). Deliverables include:
• Fully documented batch manufacturing records (BMR) and process flow diagrams.
• Characterization data including 1H-NMR, 13C-NMR, FT-IR, HRMS, and single-crystal X-ray diffraction (XRD) where applicable.
• Comprehensive impurity profiling: identification of related substances, degradation products, residual solvents (USP <467>), heavy metals (USP <232>/<233>), pesticide residues, and microbial bioburden.
• ICH Q1A accelerated (40°C/75% RH) and real-time long-term (25°C/60% RH) stability protocols and ongoing testing data.
• Full GLP toxicology and Phase I–IV clinical trial summaries managed in partnership with leading university hospitals.

Confidentiality forms the bedrock of our CRO/CDMO business model. Before reviewing technical briefs or receiving reference compounds, we execute legally binding, bilateral Non-Disclosure Agreements (NDAs). Project code designations are assigned to isolate information across internal laboratory teams, preventing cross-project exposure. Analytical data, column parameters, and synthetic routes are stored in encrypted, air-gapped laboratory databases with strict role-based access logs compliant with 21 CFR Part 11. All intellectual property generated during entrusted research belongs completely to the client.