Analytical Services
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Analytical Services
Services Chemistry/Chromatography Microbiology Sterility Testing Method Development & Validation Stability Studies
Market Pharmaceutical Biotech Cosmetic Veterinary
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Certifications Inspected by the US Food and Drug Administration
May 2012
Certified by Health Canada’s Health Products and Food Branch Inspectorate (HPFBI) May 2011
2011Controlled Drugs and substances License April 2012
Audited and qualified by many global pharmaceutical organizations Every two weeks
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Analytical highlights Well-established businesses
since 1990 Dominant market position
in Quebec Modern facilities FDA and HPFBI compliant Niche in sterility testing Large narcotics vault Walk-in Stability Rooms
Employees Over 110
Square Footage 32,000
Certificates of Analysis
1000+/mth
HPLC’sUPLC’s
manymany
GC’s many
AAS many
ICP-MS one
Dissolution Apparatus
many
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Chemistry and Chromatography
Our skilled and competent Chemistry group uses a wide range of methods to test both raw materials and finished products in accordance with compendial procedures including but not limited to:
USP/NF, BP, Ph.Eur, JP, FCC, ACS, AOAC, AOCS, In-house and client supplied methods.
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Samples Analyzed
We analyze many types of samples including but not limited to:
Pharmaceutical, veterinary, cosmetics, natural health products. Finished products: tablets, capsules, liquids, parenterals, otic and
ophthalmic drops, semisolids, creams, gels, shampoos and suppositories
Raw materials: actives, fillers, binders, lubricants, colours and other excipients
Container/packaging components: plastics, glass, foils, bottles, strip packs and cards
In-process products: bulk mixtures of solids or liquids prior to filling into capsules, bottles, vials and syringes, or before compressing into tablets
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Analytical Services Provide Dissolution studies Spectroscopy UV-VIS, IR Physical and wet chemical analysis Residual solvents Stability storage and testing Method development and validation Total organic carbon (TOC) Process and cleaning validations Container/packaging testing Vitamin assays Antibiotic assays Enzymatic testing
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UPLC HPLC – UV/visible, diode-array, fluorometric, electrochemical,
conductivity, refractive index GC – Flame ionization, and thermal conductivity detection, capillary
and headspace techniques, mass spectrometry Dissolution – USP methods I, II, III and V Spectroscopy – InfraRed and UV-VIS AAS – Atomic Absorption Spectrophotometer Flame and graphite
furnace ICP-MS
Instrumentation
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Microbiology & Sterility Testing Neopharm Labs offers microbiology and sterility testing to help ensure
the safety of various products and ingredients including pharmaceuticals, cosmetics, personal care products, vitamins, water, veterinary products, natural health products, etc. All analysis are performed in compliance with cGMP requirements using methods from relevant compendia and pharmacopoeia.
Our experienced microbiology team has expertise in a variety of compendial assays, including: USP/NF AAMI BP/ Ph.Eur JP AOAC AWWA FDA Client supplied methods.
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Microbiology - Analytical iServices Provided
Antibiotic-microbial assays Antimicrobial effectiveness
testing (AET) Microbial limits Bioburden analysis Desinfectant testing Optical microscopy Water testing
Vitamins Bacterial endotoxin test Methods development and
validation Particle size analysis Microbial identification Crystallinity Sterility testing
The following analyses are performed in compliance with cGMP requirements:
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Team led by Renaldo Lucherini 23 years experience in pharmaceutical and bioanalytical method development and validation.
Collective team experience – 60 years HPLC – RP, NP, Ion exchange Detection – UV, DAD, FLD, ELSD, RID, and Conductivity GC – FID, TCD
Method Development and Validation Services
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Method dev., Method transfer, Method validation, Cleaning validation, USP verification, Forced degradation studies, Assays, Impurities, Residual solvents, Formulation stability, Reverse engineering.
Microbiology Validation Team led by Isabelle Gladu
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Neopharm partnershipand tradition
The quality and integrity of the work is what has always distinguished Neopharm from the competition. This is why Neopharm retains many major global clients who trust us for all these years.
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Contact Us
Neopharm Labs Inc.865 Michele-Bohec Blainville (Quebec)J7C 5J6
www.neopharm.ca
Tel: (450) 435-8864Fax: (450) 435-7595
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Key contacts Business Development – Eric Ittah
Ext.: 364 [email protected] Business Development – Marie-Josee Lachapelle
Ext.: 330 [email protected] Customer Service
Ext.: 331 [email protected] Director, Laboratories– Lina Iacobaccio
Ext.: 363 [email protected] Director, Quality Assurance – Nancy Shore
Ext.: 332 [email protected] President and CEO– Luc Mainville
Ext.: 307 [email protected]