Guanidine HCl 6M - GMP Denaturant

BIO PHARMA GRADE | GH4120 | CAS# 50-01-1

C of As and Tech Docs

INTENDED FOR CRITICAL BIOPHARMA APPLICATIONS

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formula-image

BIO PHARMA GRADE / GH4120

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

pKa @ 20˚C: 13.6

Guanidine Hydrochloride 6M solution can be used to denature proteins which become randomly coiled with no residual structure. This concentration is also used to decrease enzyme activity. The denatured proteins can be modified or analyzed using mass spectrometry, electrophoresis and enzymatic digests. As a chaotropic agent, Guanidine Hydrochloride solution is also used to break the hydrogen  bonds in the structure of proteins and increase the solubility of hydrophobic molecules.

These are general specifications. BioSpectra will customize our products to meet your quality based requirements.

 
ANALYSIS SPECIFICATIONS
Appearance and Color  
Clear, Colorless Liquid
Heavy Metals  
< 10 ppm
Identification (IR)  
Passes Test
Iron  
≤ 3 ppm
Molarity  
5.5-6.5 M
Printable Version
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
List of C of As files
GH4120-004-1116.pdf
GH4120-003-1116.pdf
GH4120-002-0916.pdf

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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 Guanidine Hydrochloride GH4120 is performed at BioSpectra’s Stroudsburg, PA facility utilizing dedicated equipment. Equipment used in the manufacturing of GH4120 is cleaned in accordance with BioSpectra’s Cleaning Validation Plan.
  • Guanidine Hydrochloride 6M is a clear colorless solution.
  • 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 6M GH4120 manufactured at BioSpectra and its raw materials are not derived from or come in contact with animal parts, products, and/or byproducts.
  • Guanidine Hydrochloride 6M manufactured at BioSpectra and any raw materials used in the manufacture of Guanidine Hydrochloride 6M at BioSpectra are not subject to genetic modification.
  • Synonyms: Guanidine Monohydrochloride, Guanidinium Chloride, Guanidinium Hydrochloride.
  • Manufactured with USP grade purified water.

GMP Compliance:

Bio Pharma Grade Guanidine Hydrochloride 6M GH4120
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. This Grade of Guanidine Hydrochloride 6M
is not suitable to be used as an Active Pharmaceutical
Ingredient, Drug, Drug Product or household item.

Expiration/Retest Date:

The recommended retest period for Guanidine
Hydrochloride 6M  is two years from the date of manufacture.

Storage and Shipping Conditions:

Ship and Store in ambient temperature.

Package Sizes:

Available in 200L drums and totes.