ICH-Q7 GMP Manufactured Product
GUANIDINE HCl
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
Product Specifications
| ANALYSIS | SPECIFICATIONS | ||
|---|---|---|---|
|
≤0.01% |
||
| Appearance and Color | White / Crystals | ||
|
99.5% – 101.0% | ||
| Chloride and Sulfate, Sulfate |
≤0.005% |
||
|
≤ 50 EU/g | ||
|
None Detected None Detected None Detected |
||
|
Passes Test | ||
|
≤0.1500 a.u. max ≤0.0300 a.u. ≤0.0300 a.u. |
||
|
Meets the Requirements of test A | ||
|
≤0.005% |
||
|
≤0.5% | ||
|
Melting Range |
184°C - 188°C | ||
|
≤ 100 CFU/g ≤ 100 CFU/g |
||
|
4.5-6.0 | ||
|
≤0.5% | ||
|
Passes Test |
||
|
≤5 ppm max. ≤5 ppm max. ≤5 ppm max. ≤5 ppm max. |
||
|
Water Insoluble |
≤0.05% |
Printable Version
General Product Description:
- The manufacturing of Guanidine Hydrochloride GHCL-3250 is performed at BioSpectra’s Stroudsburg, PA facility and is conducted in a dedicated processing area using only dedicated equipment.
- Guanidine HCl is a White Crystalline product.
- Molecular Formula: CH5N3 • HCl
- Molecular Weight: 95.53 g/mol.
- CAS Number: 50-01-1.
- There are no known major food allergens (as defined by FDA and WHO) in the manufacture of this product.
- BioSpectra certifies that all Guanidine Hydrochloride GHCL-3250 manufactured at BioSpectra and its raw materials are not derived from or come in contact with animal parts, products, and/or byproducts.
- Guanidine Hydrochloride manufactured at BioSpectra and any raw materials used in the manufacture of Guanidine Hydrochloride at BioSpectra are not subject to genetic modification.
- Synonyms: Guanidine Monohydrochloride, Guanidinium Chloride, Guanidinium Hydrochloride.
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.
GMP Compliance:
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.
Retest Date:
The recommended retest period for Guanidine Hydrochloride is two years from the date of manufacture.
Storage and Shipping Conditions:
Ship and store in ambient temperature. Store in a clean and dry area. Store in the original container.
Package Sizes:
10kg, 25 kg and 50 kg pails.
Bulk GMP Fine Chemicals exclusively manufactured in North America
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.