Stability Testing by HPLC

TABLE 2 Specification Table of a Drug Product (A Typical Example) 

Product name Analgesic-ABC Product ID Lot 5678abc Dosage strength 10 mg Stage IND Phase I 

Test attribute Method no. Specification Result Pass/fail 

Appearance 5-001 Round, white tablet Conforms to Pass 

In stability testing, HPLC is the most frequently used chromatographic technique for assay. HPLC has illustrated the benefits of speed, resolution, accuracy, and sensitivity, and HPLC can interface with many detectors that other analytical techniques are unable to offer. 

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