Pharmaceuticals
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GMP QC Routine Testing
cGMP quality control testing for excipients, intermediates, raw materials and finished products, supporting the pharmaceutical, nutraceutical, natural health product, chemical and food industries.
- Methods by USP, NF, EP, JP, ACS, etc.
- Raw materials methods
- Trace Organic Analysis
- Pesticides Analysis
- Elemental Analysis
- Heavy Metals Analysis
- Microbiology
Method Development and Validation
Our services range from the development of new analytical methods to remediation (optimization or improvement) of outdated procedures.
Once a method is developed, validation protocols are prepared and experiments are executed according to Health Canada, FDA and ICH guidelines for method validation. Our scientists are experienced in validating not only chromatographic procedures, but a wide range of other analytical techniques include but not limited to:
- Titration and colorimetric techniques
- Headspace GC/MS
- HPLC and et IC
This wide capacity of analytical experience allows us to quickly generate protocols that meet regulatory demands. Our goal is to help you stay efficient and minimize mutual efforts.
Sexual Encancement Product Testing
Labofine can complete testing for drugs, pharmaceuticals and products listed below.
- Sildenafil
- Vardenafil
- Sulfoaildenafil
- Desmethyl carbodenafil
- Tadalafil
Stability Studies
Pharmaceutical stability studies are provided for all stages of drug development, from early stress studies to development of stability indicating assays, through clinical and finished product programs. Our team is fully conversant with ICH Q1A (R2) guidelines for new drug substances and food and nutraceuticals.
On-site storage stability facilities are located at our Laval facility.
Storage Stability Conditions
- 25ºC / 60% RH
- 30ºC / 60% RH, 30ºC / 65% RH and 30ºC / 70% RH
- 40ºC / 75% RH
- 50ºC / 75% RH
- 2-8ºC, -20ºC, -40ºC and -80ºC
- Photostability (ICH Options 1 & 2)
- Specialized conditions
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