Analytical Services

Services Chemistry/Chromatography Microbiology Sterility Testing Method Development & Validation Stability Studies

Market Pharmaceutical Biotech Cosmetic Veterinary

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

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

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.

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

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

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

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.

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:

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

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

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.

Contact Us

Neopharm Labs Inc.865 Michele-Bohec Blainville (Quebec)J7C 5J6

www.neopharm.ca

Tel: (450) 435-8864Fax: (450) 435-7595

Key contacts Business Development – Eric Ittah

Ext.: 364 eittah@neopharm.ca Business Development – Marie-Josee Lachapelle

Ext.: 330 mjlachapelle@neopharm.ca Customer Service

Ext.: 331 sc@neopharm.ca Director, Laboratories– Lina Iacobaccio

Ext.: 363 liacobaccio@neopharm.ca Director, Quality Assurance – Nancy Shore

Ext.: 332 nshore@neopharm.ca President and CEO– Luc Mainville

Ext.: 307 lmainville@neopharm.ca