GUANIDINE HCl, LBLE
BIO EXCIPIENT GRADE | GH3250
INTENDED FOR CRITICAL BIOPHARMA APPLICATIONS


BIO EXCIPIENT GRADE / GH3250
CAS #: 50-01-1
Molecular Formula:
CH5N3 • HCl
Solubility in Water (g/L): 573
F.W.: 95.53 g/mol
pKa @ 20˚C: 4.5 - 6.0
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
- Stability Data Statement
- Supply Chain
- TUPP
- Formaldehyde
- Slip Agent Statement
- Nitrosamine Statement
- Phthalate, Bisphenol, Dioxin
- Catalyst
- Test Methods
- IRGAFOS
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.
These are general specifications. BioSpectra will customize our products to meet your quality based requirements.
ANALYSIS | SPECIFICATIONS | ||
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0.1500 a.u. max. 0.0300 a.u. max. 0.0300 a.u. max. |
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White / Crystals | ||
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99.5% min. | ||
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≤ 50 EU/g | ||
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None Detected None Detected None Detected |
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Passes Test | ||
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Passes Test | ||
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0.15% max. | ||
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0.5% max. | ||
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184-188oC | ||
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≤ 100 CFU/g ≤ 100 CFU/g |
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0.01% max. | ||
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4.5-6.0 | ||
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0.05% max. | ||
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Passes Test |
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0.01% max. | ||
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5 ppm max. 5 ppm max. 5 ppm max. 5 ppm max. |
Key Compliance Attributes of BioSpectra Grades | Bio Excipient ICH Q7 Compliant Manufactured | ||
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Yes | ||
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Yes | ||
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Yes | ||
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Yes | ||
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Yes | ||
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Yes | ||
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Yes | ||
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Yes | ||
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Yes | ||
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Yes | ||
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Yes | ||
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Yes | ||
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Yes | ||
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Yes | ||
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Available | ||
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Available | ||
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Yes | ||
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Yes | ||
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Yes | ||
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Available | ||
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Yes | ||
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Available | ||
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Available | ||
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Available | ||
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Available | ||
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Yes | ||
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Yes | ||
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Yes | ||
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No | ||
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No |
List of C of As files |
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GH3250-006-0720.pdf |
General Product Description:
- The manufacturing of Guanidine Hydrochloride GH3250 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: CH 5N 3 .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 GH3250 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 is manufactured in accordance with GMP guidelines and is suitable to be used only as the following: ICH Q7 and IPEC Compliant GMP Manufactured Excipient for use in further Manufacturing. The material represented by this grade is not intended to be used as an Active Pharmaceutical Ingredient, Drug, Drug Product or Household Item.
Expiration/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.