Raw Materials, Excipients and API

Raw Materials, Excipients, 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.

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  • Development

    Method Development

    Procedure Development, Optimization, and Validation

    IAL offers comprehensive method development, optimization and method validation services through a staff of knowledgeable and experienced pharmaceutical senior scientists.

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  • Impurities by ICP/MS

    Elemental Impurities by ICP/MS

    ICH Q3D and USP <232> and <233>

    IAL helps implement USP guidelines replacing wet chemical “heavy metals” limit tests with more reliable, faster and lower-cost ICP/MS techniques.

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  • Stability

    Stability Services

    Stability Testing and Services

    Evaluation of stability is a critical aspect of drug substance and drug product testing.

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  • Materials

    Raw Materials, Excipients and API

    Compendial Testing

    Ensuring that your raw materials meet specifications is essential to prevent product failure.

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  • Storage

    Reserve Sample Storage

    Controlled Chambers for Retain Samples and Customer Complaint Testing

    FDA Title 21 Section 211.170 indicates that reserve samples of active ingredients as well as drug products that are representative of entire lots shall be retained.

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  • Personal Care

    Personal Care Product Testing

    Cosmetics and Other Personal Care Products

    IAL is an independent contract testing and research laboratory. Our services include providing formulators and manufacturers of cosmetics and other personal care products testing so that they can meet regulatory and safety requirements.

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  • Cleaning

    Cleaning Validation

    Guidance on Plan Development and Execution

    IAL is a cGMP compliant facility available for developing, validating and performing analytical procedures used in equipment cleaning validation.

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Contact Us

Office hours

Mon-Fri 8am - 5:30pm
Sat-Sun Closed
Holiday Schedule

Location

Integrated Analytical Laboratories, LLC
273 Franklin Road
Randolph, NJ 07869

Sample pick-up/drop

Mon-Fri 8am - 6:30pm
Sat-Sun Closed

Contact

Phone 973-361-4252
Fax 973-989-5288