Guanidine HCl - GMP Denaturant

BIO PHARMA GRADE | GH4220 | CAS# 50-01-1

C of As and Tech Docs

INTENDED FOR CRITICAL BIOPHARMA APPLICATIONS

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BIO PHARMA GRADE / GH4220

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

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
Absorbance (6M)

230 nm

260 nm

275 nm

0.2000 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% max.
pH (6M)  
4.5-6.0
Residue on Ignition  
0.05% max.
Solubility (6M)  

Passes Test

Sulfate  
0.01% max.
Trace Metals

Arsenic (As)

Copper (Cu)

Iron (Fe)

Lead (Pb)

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
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

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Review the below Intended End Use Statements for each Grade and Choose the Product Grade that is most applicable to your use.


a.) Bio Pharma Grade INTENDED USE: Material represented by this Grade is suitable to be used only as the following: IPEC Compliant GMP Manufactured Chemical, for use in further Manufacturing or as a Reagent for Laboratory and Research. The material represented by this Grade is not suitable to be used as an Active Pharmaceutical Ingredient, Drug, Drug Product or Household Item.


b.) Bio Excipient Grade INTENDED USE: Material represented by this Grade is suitable to be used only as the following: ICH Q7 Compliant cGMP Manufactured Excipient for use in further Manufacturing. The material represented by this Grade is not suitable to be used as an Active Pharmaceutical Ingredient, Drug Product or Household Item.


c.) O Bio Active Grade INTENDED USE: Material Represented by this Grade is suitable to be used only as the following: ICH Q7 Compliant cGMP Manufactured Active Pharmaceutical Ingredient for use in further Manufacturing or use in Drug Product Manufacturing. The material represented by this Grade is not suitable to be used as a Sterile or Injectable Active Pharmaceutical Ingredient, Drug Product or Household Item. (This statement will change depending on the status of your Drug Application in accordance with 21 CFR §201.122)

General Product Description:

The manufacturing of Bio Pharma Grade Guanidine
Hydrochloride GH4220 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
GH4220 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 GH4220
is manufactured in accordance with GMP guidelines
and is suitable to be used only as the following: IPEC
Compliant GMP Manufactured Chemical, for use in
further Manufacturing or as a Reagent for Laboratory
and Research. 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:

10 kg, 25 kg and 50 kg pails.