ICH-Q7 GMP Manufactured Product
*Low Bioburden, Low Endotoxin
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 inthe 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
pH @ 20°C: 4.5 - 6.0
| ANALYSIS | SPECIFICATIONS | ||
|---|---|---|---|
|
Acidity |
≤ 0.01% |
||
|
Appearance and Color |
White / Crystals |
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| Appearance of solution (6 mol/l; water) | Clear and Colorless | ||
| Assay (Dried Basis) | 99.5% – 101.0% | ||
| Bacterial Endotoxins | ≤ 2.5 IU/g | ||
| Chloride (Cl) (Argentometric) | 36.5 – 37.5% | ||
| Chloride and Sulfate, Sulfate | ≤0.005% | ||
|
None Detected |
||
|
≤ 10 ppm | ||
|
Passes Test |
||
|
≤0.10 a.u. ≤0.03 a.u. ≤0.03 a.u. ≤0.20 a.u. ≤0.20 a.u. |
||
|
Meets the Requirements of test A |
||
|
≤0.005% |
||
|
≤ 0.5% |
||
|
≤ 0.01% |
||
|
184°C – 188°C |
||
|
4.5 – 6.0 |
||
|
5.0 – 6.5 |
||
|
Residue on Ignition |
≤ 0.05% | ||
| Solubility (6M) | Passes Test | ||
| Sulfated Ash (600 °C) | ≤ 0.05% | ||
| TAMC |
≤ 100 CFU/g |
||
| TYMC | ≤ 10 CFU/g | ||
| Bile-tolerant gram-negative bacteria (absent in 1 g) |
Passes Test |
||
| Candida albicans (absent in 1 g) |
Passes Test |
||
| Escherichia coli (absent in 1 g) |
Passes Test |
||
| Pseudomonas aeruginosa (absent in 1 g) |
Passes Test |
||
| Salmonella (absent in 10 g) |
Passes Test |
||
| Staphylococcus aureus (absent in 1 g) | Passes Test | ||
|
≤ 5 ppm |
||
| Water (According to Karl Fischer) | ≤ 0.5% | ||
| Water Insoluble |
≤ 0.05 % |
Printable Version
Bio Excipient Grade Guanidine Hydrochloride, GHCL- 3253 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.