GMP Denaturant
GMP Manufactured Process ChemicalGUANIDINE HCl, GMP Grade
Product Code: GHCL-4220 | Previously: GH4220
Intended For Critical Biopharma Applications
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.
Product Specifications
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0.0300 a.u. max. 0.0300 a.u. max. 0.2000 a.u. max. |
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White / Crystals | ||
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99.5% min. | ||
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None Detected None Detected None Detected |
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Passes Test | ||
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0.15% maximum | ||
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0.5% maximum | ||
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184-188oC | ||
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0.01% maximum | ||
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4.5-6.0 | ||
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0.05% maximum | ||
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Passes Test |
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0.01% maximum | ||
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5 ppm max. 5 ppm max. 5 ppm max. 5 ppm max. |
| Key Compliance Attributes of BioSpectra Grades | Bio Pharma Grade IPEC GMP Compliant Manufactured | ||
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| Customized Additional Specifications | |
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| indicates an attribute or level of compliance which is granted or available based on the purchase of the product grade. |
| Bio Pharma Grade: Intended for use as IPEC cGMP Compliant Chemical |
| LBLE: LBLE applies when product specifications include requirements for Bioburden Testing (TAMC/TYMC and/or Endotoxin). LBLE stands for Low Bioburden, Low Endotoxin non-sterile products suitable for further use in parenteral manufacturing and other sterile applications. |
COAs and Tech Docs
- Printable Spec Sheet
- Product Inquiry
- Compliance
- C of As
- SDS
- Elemental Impurities
- Regulatory Packet
- Process Flow Diagram
- GMP Statement
- Animal Origin Statement
- BSE/TSE
- Allergen
- Mycotoxin/Aflatoxin
- GMO Statement
- Melamine
- Residual Solvents
- Gluten Free
- Ingredient Declaration
- REACH
- Prop 65
- Stability Data Statement
- Supply Chain
- TUPP
- Formaldehyde
- Slip Agent Statement
- Genotoxic Impurities
- Phthalate, Bisphenol, Dioxin
- Catalyst
- Test Methods
- IRGAFOS
- Nitrosamine Risk Assessment
- Label Copy
GHCL-4220
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
General Product Description:
- The manufacturing of Bio Pharma Grade Guanidine Hydrochloride GHCL-4220 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: NH2C(NH)NH2HCl.
- 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-4220 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 Pharma Grade Guanidine Hydrochloride, GHCL-4220 is suitable for use as a process chemical. It is manufactured in accordance with the IPEC-PQG Joint Good Manufacturing Practice Guide. This grade of Guanidine Hydrochloride is not suitable to be used as an Active Pharmaceutical Ingredient, Drug, 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.
Package Sizes:
10 kg, 25 kg and 50 kg pails.
Additional Packaging Information
https://www.biospectra.us/technical/packaging