ICH-Q7 GMP Manufactured Product
ANALYSIS | SPECIFICATIONS | |||||||||
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White / Crystals | |||||||||
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99.5% minium. | |||||||||
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None Detected |
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Passes Test | |||||||||
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0.5% max. | |||||||||
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115-121ºC |
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5.0-7.0 | |||||||||
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Passes Test | |||||||||
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5 ppm max. |
Printable Version
Bio Excipient Grade Guanidine Thiocyanate GTHI-3220 is suitable for use as an excipient. It is manufactured in accordance with the ICH-Q7 Good Manufacturing Practice Guide. This grade of Guanidine Thiocyanate is not suitable to be used as an Active Pharmaceutical Ingredient, Drug Product or Household Item.
Pictograms:
Signal word: Danger
Hazardous Statements:
H302 – Harmful if swallowed
H312 – Harmful in contact with skin
H314 – Causes severe skin burns and eye damage
H332 – Harmful if inhaled
H412 – Harmful to aquatic life with long lasting effects
EUH032 – Contact with acids liberates very toxic gas
EUH071 – Corrosive to the respiratory tract
The recommended retest period for Guanidine Thiocyanate is two years from the date of manufacture.
Ship and Store in ambient temperature.
10kg, 25kg and 50kg pails.
American Manufactured - FDA Registered GMP Facilities: Parenteral Excipients, GMP Small Molecule Intermediates, GMP Biological Buffers, Parenteral Carbohydrates, GMP Chlorinated Amino Acids, GMP Solutions in Sterile Single Use Packaging and other Reagent & GMP Fine Chemicals.