Quality Control Testing

 

Stason offers quality control (QC) testing for Active Pharmaceutical Ingredients (API's), pharmaceutical intermediates, excipients, and finished products.


 

 

 

Stason keeps a concise set of standard operating procedures, rigorous compliance systems and a thorough training program that ensure successful execution of quality control testing from the raw material to the finished product.

Stason has quality control systems which require strict adherence to cGMP regulations and total system quality is monitored from sample receipt to report generation.

a. Sample receipt and control
b. Sample log-in database
c. Client specific notebook system
d. Technique specific training
e. Data reproducibility guidelines
f. Documentation for complete data traceability
g. 100% secondary data review
h. 100% QA report review

Stason methods utilized for QC services include the following:

a. Client Methods
b. In-house developed and validated procedures
c. USP methods
d. PhEur methods
e. JP/JPE methods
f. BP methods
g. ACS monographs
h. AOAC testing
i. DAB compendial tests
j. FCC testing procedures

Stason supports the following pharmaceutical development activities
in our QC services group:

a. Non traditional methods execution
b. Testing of API's and intermediates
c. In-process testing support
d. Process validation design and validation testing
e. Finished product release and stability
f. Container-closure testing

Stason has analytical instrumentation and equipment to meet the
needs of quality control services to the pharmaceutical industry including:

a. HPLC
b. LC/MS/MS
c. GC
d. GC-MS
e. NMR
f. GPC
g. IC
h. TOC
i. ICP

a. AA
b. SEM
c. FTIR
d. UV-VIS
e. EDXA
f. Titrators
g. Polarimeter
h. Osmometer
i. Particle Size

    a. Dissolution
    b. Disintegration
    c. Friability
    d. Hardness
    e. KF
    f. CKF
    g. Refractometer
    h. TGA/MS
    i. Conductivity