| Function: | Hormones and Regulation of Endocrine Function of Drug |
|---|---|
| Certification: | GMP |
| Grade Standard: | Medicine Grade |
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|
Items of analysis
|
Specification
|
Results
|
method
|
|
Appearance
|
A colorless or slightly yellowish,
viscous hygroscopic liquid (may
crystallized on storage)
|
Conform
|
visual
|
|
Identification
|
A. Infrared absorption (197F)
B. The Sample solution : a
deep blue color develops.
C. The Sample solution : a
purplish red color develops.
|
Conform
|
USP
|
|
Assay(on
the
anhydrous
basis)
|
98.0%~102.0%
|
98.3%
|
See Titrime541
|
|
Water determination
|
≤ 1.0%
|
0.13%
|
USP921
|
|
Specific optical rotation
|
+29.0° ~+31.5°
|
29.8°
|
USP781S
|
|
Limit of aminopropanol
|
<0.5%
|
<0.5%
|
See Titrimetry54
|
|
Residue on ignition
|
≤ 0.1%
|
0.1%
|
USP281
|
|
Refractive Index(20ºC)
|
1.495~1.502
|
Conform
|
USP831
|
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