Trial design and interpretation
Split the same sampling event between main-component analysis and moisture testing and record when each portion was sealed. For a stored sample, compare sampling times before deciding whether the original package exceeded the moisture limit.
Recording Moisture
Moisture (ppm): Winigen WM-SOL-EMC third-party example ≤15 ppm. Agree the method and limit for the proposed grade and record the time from opening to testing. Principal component purity (%): Winigen WM-SOL-EMC third-party example ≥99.99 wt%. Request the quantification method and chromatographic resolution of impurities for the grade offered.
Will checking only the main chromatographic peak detect a change in water content?
Retest using a separate moisture method. Review blanks, time since opening and transfer conditions against an unopened same-lot sample. Electrolyte co-solvent: Compare EMC moisture, acidity and chromatographic impurity profiles under the same conditions. Record sealing and opening times.
What to record
- Sampling point in time
- Sealing time
- Main chromatographic peak
- Measured moisture
Technical references
Products and processes
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