Pharmaceuticals Analytical Support

Services and Capabilities

ADPEN provides analysis of active ingredients and marker compounds for QA/QC, purity contents, analysis of raw materials, extracts, intermediates, product release, finished products including solid dose and gel capsules, identification of impurities and active ingredients, independent method validation, method development, quality control, product registration and storage stability testing. ADPEN also runs analyzes for vitamins, herbals, natural products, nutritional products and offers screening and analysis of pesticide residues in raw materials and excipients, including lanolin.

ADPEN has been selected as a reference laboratory for collaborative work on method validation. We are registered and have been inspected by the FDA. We are at the forefront of analytical technology and method development.

Our service coverage includes North America, Central and South America, Europe and Middle Eastern countries.

ADPEN Laboratories has a staff of well trained professionals experienced in QC, research and development and residue chemistry who are ready to help you get your toughest projects or tasks completed.

ADPEN is a leading R&D contract analytical laboratory providing advanced analytical services and method development for the Pharmaceutical and Nutraceutical industries. ADPEN operates under FDA, EPA, ICH, GLP, and cGMP guidelines. We provide Compendial testing under USP, OECD, EP, BP, JP, AOAC, FCC (Food Chemical Codex) and WHO (World Health Organization). State-of-the-art instrumentation such as LC/MS, LC/MS/MS (APCI & electrospray), HPLC (UV & fluorescence), electrophoresis, GC (ECD, FPD, NPD, FID), and GC/MS (EI & CI), are available for all types of analyses.

ADPEN can develop new analytical methods, can identify or elucidate active ingredients under a research contract format, we can fingerprint raw material and finished product for quality control, we can detect impurities in raw material or finished product and provide analytical services under a fee or under contract.

ADPEN GUARANTEE OF PERFORMANCE

ADPEN Laboratories is your partner in research and development, and in helping you with your quality control tests. ADPEN Laboratories is a true independent laboratory that you can trust. ADPEN Laboratories will exercise a high standard of professional conduct in the performance of this work and in the preparation of the resulting reports and or Certificate of Analysis. ADPEN follows Good Laboratory Practices (GLP) and cGMP guidelines. In the event of error or omission in the performance of any part of the work done by ADPEN Laboratories, Inc. causing a study result or test to be unacceptable by the FDA, EPA, OECD or CODEX, ADPEN Laboratories, Inc. agrees to rerun the affected part of the study or analysis at no additional cost to the Client or Sponsor. This constitutes ADPEN Laboratories' sole responsibility on account of such error or omission. ADPEN Laboratories wants you to be satisfied with the quality of our work.

ACCREDITATION

ADPEN has been inspected by the FDA and has been recommended as a contract lab to perform testing on pharmaceutical products. ADPEN has been inspected several times by the EPA for Good Laboratory Practices requirements, have passed inspection and given acceptance letters. ADPEN is an FDA registered laboratory. Our FDA registration number is 1064435 and our EPA ID number is FL 0000121038. We also have a Drug Enforcement Administration (DEA) number RA0270114. We have been inspected by the Quality Assurance Auditors of our major multinational clients on a regular basis. ADPEN has been in business for over 15 years and conducts all its analyses under Good Laboratory Practices Guidelines, it abides by cGMP, FDA and EPA guidelines. ADPEN is member of and attends professional meetings such as AOAC, ACS, PR Chem, NNFA and International Pharmaceutical Industry Congress.

 LC/MS/MS Analyses using  - PE SCIEX API 4000 QT,

API 4000, API 3000 and API 365    

For more information please contact us by phone, Fax, or send us E-mail.

 

Telephone:     General Information: 1-(904) 645-9169

                                   Sales and Client Services: 1-(888) 428-3784

FAX:                (904) 641-8423

Address:        11757 Central Parkway, Jacksonville, Florida, USA 32224

E- mail:          General Information: info@ADPEN.com

                                      

                          Quality and Excellence at their Best

 

 Webmaster: webmaster@ADPEN.com

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