Dedicated analytical laboratories for fast track developmental work and GMP laboratory with successful track record, having proven systems for regulatory submission activities and to handle commercial sample for release, validation as well as stability studies.

Successfully Inspected twice by USFDA, in 2013 and 2017.

Solution for all Analytical activities - From project initiation to tech transfer and support for product filing as per regulatory requirements.

Work done here has resulted into many approved ANDAs for customer –e.g.- Venlafaxine HCl, Acetazolamide, Dapsone etc.

Expertise

• Expertise in In-Vitro Comparative Nasogastric (NG) and Gastronomy Tube studies as per USFDA submission requirements.
• Method development and method validation,
• Multimedia dissolution,
• Force degradation studies,
• Particle size analysis,
• Crystallinity and film coating thickness measurement on high resolution optical microscope.
• Reverse engineering studies for Innovator characterization using various techniques as per customer requirement etc.
• Characterizations of molecule using NMR, HPLC, UV, FTIR and ICP OES.
• Stability studies for Pivotal as well commercial batches of US market and other regulated market

Facility

• HPLCs (including RRLCs) with multiple - VWD,PDA,RID, FLD
• GC with HSA
• ICP-OES with VGA attachment enabling enhancement in elemental quantification
• High resolution stereo zoom optical trinocular microscope with polarised light attachment with digital image capturing in CFR compliant software.
• Dissolution machines to handle low solubility substances, light sensitive substances.
• Photo stability chamber.
• NMR with Fluorine, Carbon, Proton probes (Only for developmental analysis)

Stability Studies

Enem Nostrum Stability Services is able to design, execute and analyze pre-stability / regulatory or commercial stability studies, according to the International Council on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) conditions:

• ICH Stability cabinets to evaluate product stability based on real-time, accelerated and long-term by controlling temperature and relative humidity. 25°C & 60%RH, 30°C & 65%RH, 40°C & 75%RH, 30°C & 75%RH

Inhalation Testing Laboratory

• Expertise in ‘in-vitro’ Comparative Inhalation Techniques like Aerodynamic Assessment of fine Particles by Andersen Cascade Impactor, Next Generation Impactor, Twin Impinger etc.
• Method Development & Method Validation of Different Inhalation Techniques like fine Particles by Andersen Cascade Impactor, Next Generation Impactor for different Inhalation products like MDI’s, DPI’s
• Evaluation of Drug Delivery Devices like Holding Chambers, Nebulizers, MDI Actuator etc.

Key Equipment

• Andersen Cascade Impactor (Copley Scientific)
• Glass Impinger
• Dosage Unit Sampling Apparatus for MDI’s & DPI’s (Copley Scientific)
• Breath Simulator (Data M Engineering)
• Particle Size Analyzer (Sympatec)

Particle Size Analyzer (Sympatec)

A powerful technology for particle size analysis with different dispersing units

• Andersen Cascade Impactor (Copley Scientific)
• Sprayer - for Nasal Sprays at multi angle use
• Cuvette - For wet dispersion like suspensions and emulsions with small sample volume
• Sucell - For wet dispersion analysis
• Rodos with Vibri – for dry powder analysis
• Rodos with Aspiros – for dry powder analysis with micro-dosing unit for small sample quantity