ICH-Q7 GMP Manufactured Product
Guanidine Hydrochloride 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 is commonly used in the purification of RNA by dissociating the RNA into its nucleic acids and protein forms. At higher concentrations, Guanidine Hydrochloride 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
pKa @ 20˚C: 4.5 - 6.0
| ANALYSIS | SPECIFICATIONS | ||
|---|---|---|---|
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≤0.01% |
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| Appearance and Color | White / Crystals | ||
|
99.5% – 101.0% | ||
| Chloride and Sulfate, Sulfate |
≤0.005% |
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|
≤ 50 EU/g | ||
|
None Detected None Detected None Detected |
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|
Passes Test | ||
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≤0.1500 a.u. max ≤0.0300 a.u. ≤0.0300 a.u. |
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Meets the Requirements of test A | ||
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≤0.005% |
||
|
≤0.5% | ||
|
Melting Range |
184°C - 188°C | ||
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≤ 100 CFU/g ≤ 100 CFU/g |
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|
4.5-6.0 | ||
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≤0.5% | ||
|
Passes Test |
||
|
≤5 ppm max. ≤5 ppm max. ≤5 ppm max. ≤5 ppm max. |
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|
Water Insoluble |
≤0.05% |
Printable Version
RESIDUAL SOLVENTS: Based on the manufacturing process and the controlled handling, storage and analysis of this product, this product complies with the requirements and specifications listed in the current USP method <467> Tables 1, 2, 3, or 4.
Bio Excipient Grade Guanidine Hydrochloride, GHCL-3250 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 is not suitable to be used as an Active Pharmaceutical Ingredient, Drug Product or Household Item.
The recommended retest period for Guanidine Hydrochloride is two years from the date of manufacture.
Ship and store in ambient temperature. Store in a clean and dry area. Store in the original container.
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.