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Capabilities

LIQUID & TOPICALS DIVISION
Our Liquid and Topicals Division provides a full turnkey solution.

Liquid & Topicals Division

Analytical Lab

About
The laboratory group at Aphena Pharma Solutions, Easton, MD, is part of the Quality Department. The laboratory group is comprised of two laboratories: A physical-chemical analytical laboratory and a microbiological laboratory. The laboratories have the ability and resources to manage all testing programs from raw material, in-process, finished products and entire stability program. The laboratories have demonstrated abilities to provide cost effective analytical support (fit-for-purpose) for product development, manufacture and marketing. Testing activities in both laboratories are conducted with strict adherence to cGMP in compliance with USA and international regulatory requirements.
Support Capabilities
Analytical Methodology/Equipment:
  • HPLC, normal and RP, with UV/PDA detection.
  • GC with FID detection
  • UV/Vis, TOC, RI, KF, Viscometer, pH meter, Conductivity meter
  • Various wet chemistry and physical measurement/equipment.
  • Stability Chambers 25°C/60 RH and 40°C/75% RH
Raw Materials Testing:
  • The laboratories at Aphena are capable of managing (generate raw materials and product specification, supplier/materials qualification, material re-evaluation, etc.) and testing including most compendial tests (e.g. USP, EU, JP, etc.) and microbiological tests.
  • The labs will on occasion perform analytical methodologies that are provided by raw materials manufacturers, Aphena clients or other non-routine or non-compendial tests.
  • If and when it proves to be cost effective to Aphena clients or that particular equipment required for the test is not yet updated or available to the labs, some tests are outsourced to a reputable third party laboratory, however this process managed by the laboratories for Aphena clients. Example: USP residual solvent test will be at a third party lab because our GCs lack a headspace sampler.
Test Methods
The labs can develop and validate fit-for-purpose methods, improve existing methods as need, or transfer clients’ method in a cost effective and compliant process.
Support for Product Development, Manufacture and Marketing:
In-process and finished product testing are typically performed in-house on timely bases. The laboratories provide cost effective testing for in-process and finished products, and stability testing.
Stability Studies:
The Aphena laboratories are capable of managing entire stability program which include writing protocols/strategies which are compliant and fit for the stage of product development, and provide interim and annual reports. Stability study conditions such as 30°C/65 RH, 70°C/75% RH or 70°C, etc., will be stored at a third party lab, however the Aphena labs coordinate sample pull and perform the analytical tests and reports.
   
 
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