Our characterization services for NCEs, generics and first generics help assess the quality characteristics of drug products like physical and chemical properties, which are primary elements to ensure the desired quality, considering the safety and efficacy of the drug product. We help to understand physical, chemical and microbiological properties or characteristics that should be within an appropriate specification to ensure the desired product quality.
Stages of Drug Product Analytical Services
- Analytical support to early phase preformulation studies and product development
- Analytical Method Development
- Analytical Method Validation
- Analytical Method transfer
- Stability analysis (Developmental, Clinical and Registration batches)
Capabilities
- Assay
- Degradation products / Related substances / Impurities content
- Dissolution
- Chiral purity
- Identification by UV/PDA/IR/TLC
- Polymorphic form identification
- Preservative content
- Antioxidant content
- Content Uniformity
- Water content by KF
- Loss on Drying
- Viscosity
- Acid Neutralizing capacity
- Particulate matter (visual and sub-visible)
- Residual solvents
- Microbial Limit tests for the various microorganisms including BCC
- Sterility and Bacterial Endotoxins Test (BET)
- Antimicrobial Effectiveness Test (AET) / Preservative Efficacy Test (PET)
- Elemental impurities
- Nitrosamine impurities
Instruments
- HPLC with PDA, UV, MWD, ELSD, RI and CAD detectors [Water’s / Agilent makes]
- UPLC [Water’s Acquity]
- Dissolution apparatus [Electrolab make Trust-E14, Trust E-08, EDT-14Lx, EDT-08Lx and Trust E-08 with iDisso 6u HD models and Agilent make Dissolution apparatus (708-DS)]
- Small volume Dissoluiton apparatus [Electrolab make]
- Stability chambers including Photostability chamber [Thermolab make]
- Franz Diffusion Cell [Teledyne Make Phoenix DB-06]
- UV-Visible spectrophotometer [Shimadzu, UV-2600]
- GC with Head-space [Agilent make]
- Micro, Analytical and Top load Balances [Makes of Sartorius and Mettler Toledo]
- Sonicator [Hwashin make Powersonic 420]
- Shaking water bath [Lab companion make]
- Centrifuge [Eppendorf make 5810, Hermle make Z36HK]
- Rotary shaker [Jeotech SK-600]
- Water purification system [Milli-Q, IQ 7000]
- Refrigerators [Samsung and Vestfrost make]
- Sophisticated instruments like NMR 400 MHz, ICP-MS, DSC, TGA and FT-IR
- Ion chromatography [Metrohm make]
- Viscometer [Brookfield AMETEK (DV Next-RV)]
- Amino acid analyser [Sykam make]
- Volumetric and Coulometric KF Auto titrator [Metrohm make]
- Particle size analyzer [Malvern Mastersizer 3000]
- Zetasizer [Malvern (Nano-ZS)]
- Preparative HPLC [Agilent make]
- Isolator [Applied Containment Engineering]
The Analytical Services are Explored for Below Drug Products
- Aurigene has decades of experience in providing end to end analytical services for the Drug Product.
- Services include analytical method development, validation and transfer complying to regulatory and pharmacopeial requirements.
- Aurigene is equipped with sophisticated labs, viz. Formulation-Analytical Research And Development (FAR&D) Lab, Dedicated High Potent AR&D and Validation Labs.
- Our expertise include phase appropriate analytical method developments for Drug products containing molecules, viz. Potent, Non-Potent, Cytotoxic, Non-cytotoxic, UV-Active chromophores, UV-Inactive chromophores, Small, Large and Polar molecules.
- Aurigene employs use of New Generation DigitaIized tools for the execution of analytical experiments, documentation of the analytical reports, monitoring of the changes via quality notifications and employee SOP’s training, etc.
Dedicated High Potent Analytical Lab
Aurigene is equipped with dedicated High potent Analytical Lab for handling of Drug Products containing High Potent / Cytotoxic API’s, with the below set of instruments.
- HPLC instruments with UV, DAD and CAD detectors
- Dissolution apparatus (USP-Apparatus 1 & 2 of Electrolab make-iDisso)
- Gas Chromatography with ALS and Head space injectors
- Amino acid Analyser
- Analytical Balance (Placed In Xpert filtered balanced system)
- pH meter
- Ultrasound Sonicator
- Malvern Zeta sizer Nano series (Nano-ZS)
- Isolator with HEPA cartridge for closed handling of HPAI compounds
- Pass box for sample transfer
- Fume hood for chemical handling and preparations
Changing the Order of Side Heading Sections is Provided Below
- Stages of Drug Product Analytical Services
- Analytical services for the following Drug products
- Dedicated High potent Analytical Lab
- Capabilities
- Instruments
- Extended Analytical Services
Standalone Analytical Services
- Method Developments + Validations
- Method Development + Validations + Transfers
- Method Developments + Validations + Transfers +Stability Analysis
- Verification of Customer Developed methods + Validations +Analytical Method Transfers
- Verification of Customer Validated methods +Analytical Method Transfers + Stability Analysis
- Standalone Analytical Method Developments for the various Drug Products is summarized in Table below.
Why Aurigene Drug Product Characterization Studies and Testing Services?
Experience with various characterization techniques
Expertise and multi disciplinary skill set team
USFDA-inspected labs with advanced instrumentation
Understanding of various regulatory and pharmacopeial requirements
Specialized separate expertise team exist for handling advanced instruments
Phase appropriate Analytical methods developed and validated
New generation digitaIized tools exist for the execution of all analytical activities.
Dedicated Project manager exist for driving the project mile stones.
Other Services
Virtual Tour
Hyderabad R and D Center
Bangalore R and D Center
Drug Formulation Services
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