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Drugs & Cosmetic Testing Services
- Offered ByEDWARD FOOD RESEARCH AND ANALYSIS CENTRE LTD.
- Product Added OnJul 16, 2019
Kolkata, West Bengal...
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Subhas Nagar, P.O.- Nilgunj Bazar, Barasat, Kolkata, West Bengal, 700121, India
Product Details :-
- Offered ByEDWARD FOOD RESEARCH AND ANALYSIS CENTRE LTD.
- Product Added OnJul 16, 2019
Product Description :-
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 Testing
We are equipped to analyze Drugs raw material and excipients as per latest pharmacopeia.
Pharmacopeia we are following
- USP
- BP
- EP
- IP
- and JP
- Identification Tests
- Trace metals analysis by using AAS and ICP - MS techniques
- Organic Volatile Impurities and Residual Solvents as per USP
- Heavy Metals
- Pharmaceutical Grade Water testing as per USP and BP
Method Development and Validations Service
We are also offering Analytical method development and validation services.
Guidelines we are following:
- ICH
- Assay
- Dissolution
- Impurities
- Trace metals
- Residual solvents
- Physico - Chemical tests
Stability Storage and Testing
We have stability storage chambers covering wide range of environmental conditions including.
- Refrigerated condition
- Primary 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.
- Assay
- Dissolution
- Impurity Profiling
- Stability Studies
Extractables and Leachables:
Extractables and Leachables are chemicals that can be released /migrated from primary and secondary packaging materials such as
- Containers
- Container liners
- Closures
- Closure liners
- Stopper over - seals
- Container inner seals
- Administration accessories etc.
Typical contaminants include:
- Phthalate esters
- Cyanides
- Nitrosamines
- Benzopyrenes
- Trace metals etc.
We can do the analysis to determine the potential contaminants in various drug substances and drug products.
Microbiological Analysis
At Efrac we are doing Compendial tests for Drugs, Pharmaceuticals, Disinfectants and Healthcare products.
Methods we are following:
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- Microbiological assays: Vitamins, Disinfectants
- Sterility: Hospital ware, surgical items, injectables and sterile pharmaceutical products
- Bacterial endotoxins
- Efficacy of antimicrobial presercation/Antimicrobial preservative effectiveness
- Microbial limit tests/Bioburden/Microbial contamination detection
- Total Aerobic microbial count/Aerobic viable bacterial count
- Combined Yeast & Mold count
- Escherichia coli
- Salmonella
- Pseudomonas aeruginosa
- Staphylococcus aureus
- Enterobacteria & other gram negative bacteria
- Clostridia
- Clostridium perfringens
- Bile - tolerant gram negative bacteria /Coliforms
- Candida albicans
- Process water/Reagent water quality: Viable count, Coliforms, E.Coli and any other organisms as per customer request
- Microbial Limit Test
- Antimicrobial effectiveness of preservatives/ Preservative efficacy test (AET/PET)
- Bacterial Endotoxin Test
- Sterility Test
- Disinfectant Efficacy Test
- Conventional: Microscopic, biochemical and serological.
- 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, Coliforms
- Swab 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 sampling
- Other parameters on request
Healthcare 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 testing
- Neutralization testing as per ASTM 1054 - 02
- Antimicrobial effectiveness testing of personnel hand washes.
- Germicidal value (Phenolic disinfectants - IS 1061)
- Rideal walker coefficient (RWC)
- Staphylococcus aureus coefficient (SAC)
Company Details :-
Established in 2012 , EDWARD FOOD RESEARCH AND ANALYSIS CENTRE LTD. has made a name for itself in the list of top service providers of Material & Product Testing Labs and Testing Services in India. EDWARD FOOD RESEARCH AND ANALYSIS CENTRE LTD. is listed in Trade India's list of verified companies offering wide array of Environmental Monitoring Services, Global Food Safety Testing Scenario, Environmental Testing etc. Contact here for Material & Product Testing Labs and Testing Services in Kolkata, West Bengal.
- BUSINESS TYPE Service Provider
- EMPLOYEE COUNT 500
- ESTABLISHMENT 2012
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EDWARD FOOD RESEARCH AND ANALYSIS CENTRE LTD.
SUPPLIER CONTACT DETAILS
Crm
Subhas Nagar, P.O.- Nilgunj Bazar, Barasat, Kolkata, West Bengal, 700121, India
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