Drugs & Cosmetic Testing Services at Best Price in Kolkata | Edward Food Research And Analysis Centre Ltd.

Drugs & Cosmetic Testing Services

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Product Specifications

Testing methods	Multiple
Standards followed	USP, BP, EP
Analytical techniques	AAS, ICP-MS
Sample types	Drugs, cosmetics
Turnaround time	Variable
Usage	Pharmaceutical and cosmetic product testing, ensuring quality and safety
Reporting	Detailed reports
Features	Quality testing, Expert analysis, Reliable results, Pharmacopeia compliance, Method development

Product Overview

Key Features

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

Tests we are doing

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:

Method Development Studies for:

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:

EP
USP-NF
IS

ISO
WHO
ASTM and customer specific methods.

Parameters we are testing:

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

Method Validations:

Microbial Limit Test
Antimicrobial effectiveness of preservatives/ Preservative efficacy test (AET/PET)
Bacterial Endotoxin Test
Sterility Test
Disinfectant 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, 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: