Guanidine HCl- Excipient

BIO EXCIPIENT GRADE | GH3220 | CAS# 50-01-1

INTENDED FOR USE AS AN EXCIPIENT

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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.

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BIO EXCIPIENT GRADE / GH3220

CAS #: 50-01-1

Molecular Formula:

CH5N3 • HCl

Solubility in Water (g/L): 573

F.W.: 95.53 g/mol

pH @ 20°C: 4.5 - 6.0

 
ANALYSIS SPECIFICATIONS
  275 nm
Absorbance (0.1M) 260 nm
  230 nm
 
0.0300 a.u. max
0.0300 a.u. max
0.0300 a.u. max
Appearance and Color  
White / Crystals
Assay  
99.5% min.
Enzymes

DNase

Protease
RNase

 

None Detected
None Detected
None Detected
   
Identification (IR)  
Passes Test
Insoluble Matter  
0.15% max.

Loss on Drying

 
0.5% max.
Melting Range  

184-188ºC

Nitrate  

0.01% maximum

pH (6M)  
4.5 – 6.0
Residue on Ignition  
0.05% max.
Solubility (6M)  
Passes Test
Trace Metals Arsenic (As)  
Copper (Cu)
Iron (Fe)
Lead (Pb)
5 ppm max.
5 ppm max.
5 ppm max.
5 ppm max.
Printable Version
Key Compliance Attributes of BioSpectra Grades Bio Excipient Grade ICH Q7 Compliant Manufactured
Suitable for Research and Diagnostic  
Yes
Each Batch 100% Analyzed  
Yes
Management of Change  
Yes
Validated Analytical Methods  
Yes
Compendial Testing  
Yes
Trace Metals Analyzed  
Yes
Two Year Stability  
Yes
BioSpectra Supply Chain Audit Trail  
Yes
Product Origin Statement  
Yes
Customer Quality Audits  
Yes
Customized Additional Specifications  
Yes
Multi-Compendial Testing  
Yes
Enzyme Tested  
Yes
Validated Manufacturing Process  
Yes
US Manufactured at BioSpectra  
Yes
IPEC cGMP Compliant Manufactured  
Yes
Suitable for use as Excipient  
Available
Microbial / Endotoxin Tested  
Available
Manufactured in FDA Registered Facility  
Available
Customized Manufacturing Schedule  
Available
Custom Regulatory Packet  
Available
Accelerated Stability  
Available
Type IV Drug Master File  
Available
Video Conference access to BioSpectra Sites  
Available
Complete access to Product Traceability  
Available
Access to Supply Chain Information  
Yes
ICH Q7 Qualified Utilities  
Yes
ICH Q7 Compliant Manufactured  
Yes
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General Product Description:

• The manufacturing of Guanidine Hydrochloride
GH3220 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
GH3220 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 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.

Package Sizes:

10kg, 25 kg and 50 kg pails.