ICH-Q7 GMP Manufactured Product
Guanidine Hydrochloride Buffer is a strong protein denaturant that functions as a chaotropic agent. As a denaturant, it acts to unfold proteins and turn them into their original polypeptide chains. As a chaotropic agent, it breaks down the structure of proteins. Guanidine Hydrochloride Buffer is commonly used in the purification of RNA by dissociating the RNA into its nucleic acids and protein forms. At higher concentrations, Guanidine Hydrochloride Buffer decreases enzyme activity. It is also used to increase the solubility of hydrophobic molecules.
CAS #: 50-01-1
Formula: CH5N3 • HCl
Sol. In H2O (g/L): 573
F.W.: 95.53 g/mol
pH @ 20°C: 4.5 - 6.0
| ANALYSIS | SPECIFICATIONS | ||
|---|---|---|---|
|
≤0.01% |
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|
White / Crystals | ||
|
99.5% - 101.0% | ||
| Chloride and Sulfate, Sulfate |
≤0.005% |
||
|
None Detected |
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|
Passes Test | ||
|
≤ 0.2000 a.u. ≤ 0.0300 a.u. ≤ 0.0300 a.u. |
||
|
Identification C – Chloride |
Meets the Requirement of Test A |
||
|
Limit of Nitrate |
≤0.005% | ||
| Loss on Drying | ≤0.5% | ||
|
184ºC-188ºC |
||
|
4.5 – 6.0 | ||
|
≤0.05% | ||
|
Passes Test | ||
|
≤ 5 ppm ≤ 5 ppm ≤ 5 ppm ≤ 5 ppm |
||
|
Water by Karl Fischer |
NMT 0.3%w/w | ||
|
Water Insoluble |
≤0.05% |
Printable Version
Bio Excipient Grade Guanidine Hydrochloride Buffer, GHCL-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 Hydrochloride Buffer is not suitable to be used as an Active Pharmaceutical Ingredient, Drug Product or Household Item.
The recommended retest period for Guanidine
Hydrochloride Buffer is two years from the date of manufacture.
Ship and Store in ambient temperature.
10kg, 25 kg and 50 kg 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.