ICH-Q7 GMP Manufactured Product
ANALYSIS |
SPECIFICATIONS |
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0.1 a.u. max. | ||
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Clear, Colorless Liquid | ||
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Passes Test | ||
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≤ 10 ppm | ||
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Passes Test | ||
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≤ 3 ppm |
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5.8 – 6.2M | ||
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4.5 – 6.5 |
Printable Version
Bio Excipient Grade Guanidine HCl 6M Buffer Solution, GHCL-3101 is suitable for use as an excipient. It is manufactured in accordance with the ICH-Q7 Good Manufacturing Practice Guide. This grade of Guanidine HCl 6M Buffer Solution is not suitable to be used as an Active Pharmaceutical Ingredient, Drug Product or Household Item.
The recommended retest period for Guanidine Hydrochloride 6M Buffer Solution is two years from the date of manufacture.
Ship and store in ambient temperature.
200L drums and 1135L totes.
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.