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Trismat(R) Hydrochloride, Biologics Plus, cGMP, bioCERTIFIED (TM)
Synonyms: Spectris™ Hydrochloride ; Trismat* Hydrochloride ; Tris(hydroxymethyl)aminomethane Hydrochloride
TEST | MIN | MAX |
---|---|---|
Assay, Dried Basis, by Titration | 99.5 % | |
PH OF A 1M SOLUTION | 3.7 | 4.7 |
IDENTIFICATION (IR) | TO PASS TEST | |
APPEARANCE | TO PASS TEST | |
pKa, 20°C | 8.0 | 8.4 |
MELTING POINT | 150.0 | 153.0°C |
SOLUBILITY (1M, AQUEOUS) | Clear, colorless | |
WATER (KARL FISCHER) | 0.50 % | |
Loss on Drying, @ 110°C | 0.4 % | |
TOTAL TRACE METALS | 5 ppm | |
IRON | 1 ppm | |
RESIDUE ON IGNITION | 0.1 % | |
UV ABSORBANCE @ 260 NM (1.0M IN H2O) | 0.02 | |
UV ABSORBANCE @ 280 NM (1.0M IN H2O) | 0.02 | |
UV Absorbance @ 400 nm (1.0M in H2O) | 0.01 | |
BACTERIAL ENDOTOXINS | 2.5 EU/g | |
MICROBIAL LIMITS: | ||
BIOBURDEN | 100 CFU/g | |
TYMC | 100 CFU/g | |
DNase | Not detected | |
RNase | Not detected | |
PROTEASE | Not detected | |
IDENTIFICATION | TO PASS TEST | |
RETEST DATE | ||
DATE OF MANUFACTURE |