Pharmaceuticals and
Biotechnology Analytical Support
GLP and cGMP
Guidelines
ADPEN
Laboratories is a leading independent analytical laboratory, located in Florida, providing advanced and sophisticated analytical services with experienced professionals and state-of-the-art instrumentation. ADPEN Laboratories has a strong commitment towards quality assurance and provides quality and excellence in analytical support.
ADPEN operates under GLP and cGMP guidelines, is registered
and has been inspected by the U.S. FDA.
- Analysis
of active ingredients in raw materials, blends and finished products such as
soft and hard gel caps, tablets and capsules.
-
Full Product Release testing by USP monograph.
- Analysis
of Over the Counter (OTC) drugs for quality control.
- Storage
Stability Testing
- Cleaning
Validation Testing
-
Quantitative and qualitative characterization of impurities, pharmaceutical
drugs and metabolites in biological matrices, technical material and
formulated products by LC/MS, LC/MS/MS and triple quad MS with ion trap.
- Assays
using USP methods and other compendia procedures such as, EP and JP.
-
Disintegration and dissolution tests according to USP guidelines.
- OVI and
Residual Solvent analysis USP guidelines.
-
Analytical method validation and method development services.
- Method
transfer and validation
- Clinical
Trial analytical support
- Analysis
of plasma and other biological matrices for trace levels of pharmaceuticals in
support of clinical trials and other studies.
- Analysis
of antibiotics and drugs in foods, water and pancreatin by LC/MS/MS.
See also Food Safety
-
Bioequivalence testing for generic drugs.
-
Final
Product Stability Studies under ICH/USP guidelines. Normal,
Intermediate and Accelerated Studies.
- Storage
Stability Chambers available
- Protein
and RNA analysis by electrophoresis - Experion Lab-on-a-Chip
- Color
analysis of pigments by Colorimetry
-
Identification and isolation of natural products and drugs
-
ADPEN is
registered with the FDA (Registration No.: 1064435),has a DEA permit
(RA0270114) to handle controlled drugs.
- ADPEN
uses state-of-the-art instrumentation such as:
Applied Biosystems 4000 QT LC/MS/MS,
API 4000 LC/MS/MS, API 3000 LC/MS/MS and API 365
LC/MS/MS, GC, GC/MS, HPLC, Electrophoresis Lab on a Chip
ADPEN is your partner in quality control, research and
development and method validation. ADPEN is a true independent laboratory that
you can trust. ADPEN has been providing analytical services for over 17 years,
from the major multinational World Class companies to smaller independent
start-up companies. Our services and capabilities range from complex analytical
testing and methods development to product release testing, method validation,
stability testing, quality control and compound identification.
AOAC
EP
JP
USP
cGMP
GLP
For Services and Capabilities click here
For more information please contact us by phone, Fax, or send us E-mail.
- Telephone:
General Information: 1-(904) 645-9169
- FAX: 1-(904) 641-8423
- Postal Address:
11757 Central Parkway, Jacksonville, Florida, USA 32224
- Electronic mail:
General Information:
info@ADPEN.com
-
Client Services:
services@ADPEN.com
-
Technical Support:
info@ADPEN.com
-
-
- Webmaster:
info@ADPEN.com
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