501/1, G.I.D.C. Phase-2, Vinzol Railway Crossing, Vatva Narol Ahmedabad, Gujarat - 382405 +91 9408646640Mon - Sat: 9:00AM - 8:00PM
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Our Services

Detail about our services

We Provide High Quality Services

We provide expertise through every phase of development and processes.

Azurite Pharmaceuticals’s goal is to serve clients by considerably reducing the cycle time for compound synthesis, development and commercialization. We provide expertise through every phase of development and processes.

Impurity Synthesis, Isolation and Characterization

  • Synthesis and Isolation of impurities of Regulatory Starting Materials (RSM), Intermediates, APIs and Drug Products using various techniques including Column Chromatography, preparative HPLC and SFC.
  • Structure Elucidation of Isolated Impurities by acquisition and interpretation of comprehensive 1H NMR, 13C NMR and Mass data.
  • Isolation and Characterization of degradation Impurities of API’s.
  • Structure Elucidation Report (SER) preparation for fillings.

Process Chemistry

  • The process chemistry service includes route selection and route optimization (and demo up to 50-100 g scale).
  • Process optimization & validation.
  • Custom synthesis of intermediates and APIs (GMP/non-GMP) up to gram to kilo scale.
  • Identification of Critical Process Parameter (CPP), Critical Quality Attributes (CQA) and Critical Material attributes (CMA) for developed process.
  • Purge/Spike studies for Process Impurities, Key Starting Materials and Intermediates to define the Design Space for developed process.
  • fa fa-gearComplete process analytic package including impurity profiling & working standards.
  • Custom synthesis from mg to kilograms scale.
  • Tech transfer to CRO's in India (or to any CROs of customer choice for scale up).

Chemical Sourcing Services

Azurite Pharmaceuticals has a logistics center in Ahmedabad and we partnered with reliable manufacturers in India. Our network of international and domestic vendors enables us to efficiently source high profile raw materials/ intermediates at competitive price. We are specialists in sourcing of hard to find chemicals.

Our team has expertise in optimization of sourcing process to help our customers meet their procurement objectives. We understand the pitfalls of inherent in international supply chains and proactively take steps to minimize problems.

Every compound supplied by Azurite Pharmaceuticals will be fully QC tested prior to deliver to our customers.