High-performance size-exclusion chromatographic determination of the potency of biosynthetic human growth hormone products.
A new high-performance size-exclusion chromatography method has been developed for the determination of potency of human growth hormone products. This method has been extensively validated and shown to correlate well with the hypophysectomized rat bioassay which has been used traditionally. The method is much more precise than the traditional bioassay and thus provides more reliable means of producing consistent biosynthetic human growth hormone batches.
Riggin
R M
RM
Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, IN 46285.
Shaar
C J
CJ
Dorulla
G K
GK
Lefeber
D S
DS
Miner
D J
DJ
D000818:Animals; D001835:Body Weight / Q000187:drug effects; D002356:Cartilage / Q000187:drug effects / Q000254:growth & development; D002850:Chromatography, Gel; D002851:Chromatography, High Pressure Liquid; D013006:Growth Hormone / Q000302:isolation & purification* / Q000494:pharmacology; D006801:Humans; D007202:Indicators and Reagents; D051381:Rats; D012015:Reference Standards; D013056:Spectrophotometry, Ultraviolet
D007202:Indicators and Reagents; D013006:Growth Hormone