Raw Materials, Excipients and API
Compendial Testing
Ensuring that your raw materials meet specifications is essential to prevent product failure. Raw materials that do not meet specifications create problems with product quality and uniformity. Problems can also be caused by delays due to late analytical results and these problems can be very costly. IAL understands this and strives to consistently provide excellence in all aspects of our operation to all our clients. Our scientists work diligently not only to provide data quickly but also to give you accurate, meaningful results.
IAL has extensive experience in a number of different compendia which includes but is not limited to:
- United States Pharmacopeia (USP)
- National Formulary (NF)
- British Pharmacopeia (BP)
- European Pharmacopeia (EP)
- Japanese Pharmacopeia (JP)
- Food & Chemical Codex (FCC)
- American Chemical Society (ACS)
- Association of Analytical Communities (AOAC)
- ASTM International (ASTM)
IAL's scientists are familiar with the analytical techniques required by these compendia and conducts all work according to cGMP guidelines. Client methods and specifications are also utilized when directed. When methods are received, IAL formally assigns a unique document number that is linked to the client. Client methods are transferred according to IAL or client-prepared protocols.
IAL's Raw Material Testing services include but are not limited to:
- Material Analysis by HPLC or GC
- Spectrophotometric Analysis (UV/VIS, FTIR)
- Metals Analysis by ICPMS
- Residual Solvent Testing <467>
- Compendial Testing USP, EP, BP, JP, FCC, ACS, ASTM
- Moisture by Karl Fisher
- Titrations
- Wet Chemistry
Out-of-Specification Results
When an "Out of Specification" (OOS) result is obtained, our Standard Operating Procedure mandates that we quickly check our results to ensure that the OOS is not a laboratory error. Once we verify the results, we quickly communicate the OOS to the client so that the investigation can proceed in compliance with their procedures for an OOS. IAL will take a consultative approach with our clients and we will work according to Quality Agreements and Standard Operating Procedures.
Reporting
Certificates of analysis are sent to our clients upon completion of testing and QA/QC review. When required, our staff can expedite our turnaround time to meet vigorous client turnaround times. For some tests, results can be issued within 24 hours of sample receipt. We work hard to ensure that all your analytical needs are met in the time frame you require.
IAL can also customize your reports. We can easily modify reporting formats to ensure all information pertinent to your company is provided. All documentation such as notebook pages and chromatograms is also available upon request.
Contact us to obtain excellence in service and quality data, and to allow us to become a valuable and trusted member of your team.
