QUALITY ASSURANCE & REGULATORY COMPLIANCE
WHO-cGMP BenchmarkAt RexCure Pharma, quality is designed into every stage of the formulation lifecycle conforming to Indian Pharmacopoeia monographs.
Analytical Precision & Pharmacopoeial Integrity
Our formulations comply with the standards set forth by the Indian Pharmacopoeia (IP). Every released batch is accompanied by a comprehensive Certificate of Analysis (CoA) validating chemical identity, assay potency, content uniformity, and microbial limits.
Our 6-Stage Multi-Barrier Quality Protocol
How we assure consistent bio-equivalence and purity for clinicians and patients.
Active Pharmaceutical Ingredient (API) Qualification
Vendor audits, complete chemical characterization, particle size analysis, and pharmacopoeial monograph verification prior to batch allocation.
In-Process Quality Controls (IPQC)
Automated gravimetric checks, continuous tablet hardness and friability monitoring, and disintegration timing across the entire production cycle.
High-Performance Liquid Chromatography (HPLC)
Quantitative assay testing and related substance impurity profiling to guarantee exact stated molecular potency.
Dissolution Rate & Kinetic Profiling
In-vitro dissolution testing mimicking physiological gastrointestinal conditions to verify targeted active release profiles.
Accelerated & Real-Time Stability Testing
Climatic chamber testing under ICH Zone IVb conditions (30°C / 75% RH & 40°C / 75% RH) to ensure stability throughout labeled shelf-life.
Authorized Qualified Person (QP) Batch Release
Complete batch production and packaging record (BMR/BPR) audit before granting certificate of analysis (CoA) and market distribution.
Request Analytical Dossiers or Certificates of Analysis
Hospital purchase committees, government supply agencies, and distribution partners may request specific product CoAs or batch documentation.