Drugs & Cosmetic Testing Services

Edward Food Research and Analysis Center (EFRAC) is the well known service provider of Drugs & Cosmetic Testing Services. This service is carried out under the supervision of our adroit professionals as per the set medical norms. Our Laboratory is equipped with a full array of Analytical instrumentation meeting all the medical requirements. Our offered Drugs & Cosmetic Testing Services service is offered to our customers at market leading prices. Other Detail: Pharmaceutical testing division of Efrac is well equipped to provide all the routine analysis as per the latest Pharmacopeia (IP, USP, EP, IP and JP) or customer specific procedures and specification in Drugs and Drug substances. Our Laboratory is equipped with a full array of Analytical instrumentation meeting the 21 CFR part 11 requirements. Raw Material TestingWe are equipped to analyze Drugs raw material and excipients as per latest pharmacopeia.Pharmacopeia we are followingUSPBPEPIPand JP Tests we are doing Identification TestsTrace metals analysis by using AAS and ICP - MS techniquesOrganic Volatile Impurities and Residual Solvents as per USPHeavy MetalsPharmaceutical Grade Water testing as per USP and BP Method Development and Validations ServiceWe are also offering Analytical method development and validation services.Guidelines we are following: ICH Method Development Studies for: AssayDissolutionImpuritiesTrace metalsResidual solventsPhysico - Chemical tests Stability Storage and TestingWe have stability storage chambers covering wide range of environmental conditions including.Refrigerated conditionPrimary ICH long term condition,Intermediate ICH condition,Accelerated ICH condition and for Photo stability - ICH option 1 and 2 with light intensity recording facility.Custom storage conditions can be programmed to meet customer specific requirements.Comparator Studies:Efrac offers the comparator analysis of the new products with already established brands in the following area.AssayDissolutionImpurity ProfilingStability StudiesExtractables and Leachables:Extractables and Leachables are chemicals that can be released /migrated from primary and secondary packaging materials such asContainersContainer linersClosuresClosure linersStopper over - sealsContainer inner sealsAdministration accessories etc. Typical contaminants include:Phthalate estersCyanidesNitrosaminesBenzopyrenesTrace metals etc.We can do the analysis to determine the potential contaminants in various drug substances and drug products. Microbiological AnalysisAt Efrac we are doing Compendial tests for Drugs, Pharmaceuticals, Disinfectants and Healthcare products. Methods we are following: ISIPBPEPUSP-NFISISOWHOASTM and customer specific methods. Parameters we are testing: Microbiological assays: Vitamins, DisinfectantsSterility: Hospital ware, surgical items, injectables and sterile pharmaceutical productsBacterial endotoxinsEfficacy of antimicrobial presercation/Antimicrobial preservative effectivenessMicrobial limit tests/Bioburden/Microbial contamination detectionTotal Aerobic microbial count/Aerobic viable bacterial countCombined Yeast & Mold countEscherichia coliSalmonellaPseudomonas aeruginosaStaphylococcus aureusEnterobacteria & other gram negative bacteriaClostridiaClostridium perfringensBile - tolerant gram negative bacteria /ColiformsCandida albicansProcess water/Reagent water quality: Viable count, Coliforms, E.Coli and any other organisms as per customer requestMethod Validations: Microbial Limit TestAntimicrobial effectiveness of preservatives/ Preservative efficacy test (AET/PET)Bacterial Endotoxin TestSterility TestDisinfectant Efficacy Test Microbial Identification: Conventional: Microscopic, biochemical and serological. Work Place Monitoring: Testing is performed for Air/Clean rooms/ Manufacturing facility/ Equipment/ Personnel.Bioburden/Viable count: Settle plate method (4 hrs exposure)Aerobic microbial count & combined yeasts & molds by Fallout or Swab testing (in buffer solution): AMC, Y&M, ColiformsSwab Testing (in buffer solution): AMC, Yeast and Molds, Coliforms, E.Coli, Salmonella and Enterobacteriacae.Enumeration of Lactobacillus acidophilus in dairy and pharma products.Detection of contamination of Bacillus subtilis & Bacillus cereus in pharma products.Air Sampling (By air sampler)Media plates/swabs for samplingOther parameters on requestHealthcare Products & Disinfectants:Evaluation of antimicrobial properties of different healthcare products as per customer supplied protocols/ASTM methods (ASTM 1115 & ASTM E 1174).Studies include:MIC testingNeutralization testing as per ASTM 1054 - 02Antimicrobial effectiveness testing of personnel hand washes.Germicidal value (Phenolic disinfectants - IS 1061)Rideal walker coefficient (RWC)Staphylococcus aureus coefficient (SAC)