ICH-Q7 GMP Manufactured Product
GUANIDINE HCl
*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
Product Specifications
| ANALYSIS | SPECIFICATIONS | ||
|---|---|---|---|
|
Acidity |
≤ 0.01% |
||
|
Appearance and Color |
White / Crystals |
||
| 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 |
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|
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
General Product Description:
- The manufacturing of Guanidine Hydrochloride GHCL-3253 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-3253 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.
GMP Compliance:
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.
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.