EQUIPPED FOR EXCELLENCE LED BY TECHNOLOGY
LABS
ABOUT CAPONEX CAPONEX LABS is a global Analytical testing Organization offering Regulatory Compliant Analytical research and testing Services to Pharma & Biotech Industries. We believe “The People are the strength& the backbone of the Company”, therebyCaponex was build with highly qualified, diverse skilled and self-reliance people with confidence. Our values as “Integrity”, “Commitment”,“Reliability” and “Accuracy” derives theRoad map towards our Vision.
OUR VALUES
INTERGITY
COMMITMENT
RELIABILITY
ACCURACY
OUR SERVICES Quality Control & Release Testing Analytical Method Development & Validation Impurity Profiling & Trace Metal Analysis Dissolution Profile & Formulation Analysis Extractable/leachable Analysis Microbiological Studies Stability & Photo Stability Testing Physicochemical Characterization
QUALITY CONTROL & RELEASE TESTING Chromatographic analysis ( HPLC & GC) Spectroscopic analysis (UV, MS, IR) Physical & physicochemical analysis (Particle size, DSC, TGA, Wet analysis) Analytical testing for various dosage forms (Syrups, gels, creams, patches, Solid orals) Dissolution, hardness & friability for Solid orals Trace metal analysis (ICP-MS) Morphology Screening, development &Validation ( XRD)
IMPURITY PROFILING & TRACE METAL ANALYSIS
ICP-OES, ICP-MS or AA
Genotoxic impurities method development & Validation by LC-MS & GC-MS Elemental
impurities
method
developmentand
validation
by
ICP-MS for Class 1, 2A & 2Bas per regulatory requirement Content method development andvalidation by LC-MS & GC-MS Method Development & Validation oforganic volatile impurities as per ICH guidelines Method development and validation for non-chromophoric compounds by using RI& ELSD detectors
ANALYTICAL METHOD DEVELOPMENT & VALIDATION Wide range of chromatographic techniques (HPLC, UPLC, GC, ICP & LC) Detection technologies (UV,MS, RI, FD, PDA etc.) Stability indicating assay or related substances methods for DS & DP Enantiomeric separation Dose verification for GLP studies Preservatives and antioxidants analysis Dissolution testing for organic volatileimpurities Cleaning validation
DISSOLUTION & FORMULATION ANALYSIS Dissolution-solid oral dosage form ( usp-1& usp-2) Hardness & friability Content of uniformity Delivered dose uniformity & mean delivered dose for inhalers Impurity identification & determination Chromatographic analysis Spectrophotometric analysis
PHYSICOCHEMICAL CHARACTERIZATION Materials characterization Thermal analysis Particle-size characterization Spectroscopy (FTIR, LC-MS, GC-MS, UV, etc.) Salt form, syrups, injectables screening and selection Polymorph Screening
EXTRACTABLE /LEACHABLE ANALYSIS Controlled
extraction
studies
utilizing
HPLC,LC-MS,
GC-MS,
GC-HS-MS & ICP-MS with datainterpretation and extractable screening forboth organic and inorganic materials Determination of Analytical EvaluationThreshold & Safety Concern Threshold Development and validation of analyticalmethods for potential leachable identification and quantification Material qualification for polynucleararomatic hydrocarbons(PAH), N-nitrosamines& other compounds of toxicological concerns Leachables monitoring during shelf life androutine extractable testing
MICROBIOLOGICAL STUDIES Microbial limits tests Microbial contaminant identification Microbiological assessment ofantibiotics Bacterial Endotoxins Environmental Monitoring
STABILITY STUDIES Development and Validation of stabilityindicating methods including dissolution testing CGMP registration stability programs Validated monitoring systems, 21 CFR part 11 compliant Walk-in and backup reach-in chambers Customized comprehensive documentation
BUSINESS CONTINUITY BACKUP ON BACKUP
TRANSFORMER : 500 KVA transformer with self stabilizer to address any power fluctuations. UPS : 341 KVA dedicated 4 ups systems for 100 % back up on back up all the times DG: 320 KVA online generator for additional backup. VRF AIR CONDITIONERS : Every equipment roomis having 166 % air conditioning backup with 3 different ODUs and 3 different lines for VRF supply.. SERVER : 2 physical, 3 virtual and 1 VM system with tape drive back up ensures data continuity, safety and integrity. SIEMENS PANELS : Electrical panels of siemens make for total safety and safety controls even the power before enters the building.
CAPONEX name is approximating with quality and that is believed when you work with us. As analytical testing experts, our capabilities run with the wide range of analytical, microbiology testing services & stability studies. With our skilled professional staff and cutting-edge technology, Caponex can help bring your molecule to market while attaining the utmost compliance with allregulatory standards.
WHY CAPONEX
HIGH QUALITY SERVICES ON TIME, EVERY TIME
CONTINUAL IMPROVEMENT ON QMS & COMPLIANCE
HIGH TECHNICAL COMPETENCY/ EMPLOYEE ENGAGEMENT
QUALITY POLICY
INTEGRITY, TRANSPARENCY & RELIABILTY
CREATIVITY & ACCOUNTABILTY
COMMITMENT & CUSTOMER FOCUS
WE BELIEVE
ARE THE
PEOPLE STRENGTH & BACKBONE OF THE COMPANY
When the world awaits your product, choose the lab that provides Complete capabilities and rigorous quality systems you can trust.
LABS Caponex Labs Pvt Ltd, Sy.No- 478 &
contactus@caponexlabs.com
480 Basuregadi, Medchal Mandal &
www.caponexlabs.com
Dist, Hydeabad-501401, INDIA
+91-89859 63333