GUANIDINE HCl 6M

BIO EXCIPIENT GRADE | GH3101

C of As and Tech Docs

INTENDED FOR CRITICAL BIOPHARMA APPLICATIONS

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BIO EXCIPIENT GRADE | GH3101

CAS #: 50-01-1

Molecular Formula:

CH5 N3 • HCl

Solubility in Water (g/L): 573 @ 20°C

F.W.: 95.53 g/mol

pH @ 20°C: 4.5 - 6.5

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

Absorbance 260nm
0.1 a.u. max.
Appearance and Color  
Clear, Colorless Liquid
Cyanide  
Passes Test
Heavy Metals  
≤ 10 ppm
Identification (IR)  
Passes Test
Iron  

≤ 3 ppm

Molarity  
5.8 – 6.2M
pH  

4.5 – 6.5

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  
Yes
Microbial / Endotoxin Tested  
Yes
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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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 Excipient Grade Guanidine Hydrochloride 6M, GH3101 is performed at BioSpectra’s Bangor, PA facility and is conducted in a dedicated processing area using only dedicated equipment.
  • Equipment used in the manufacturing of GH3101 is cleaned in accordance with BioSpectra’s Cleaning Validation Plan.
  • Molecular Formula: CH5N3 • HCl
  • Molecular Weight: 95.53 g/mol.
  • CAS #: 50-01-1
  • 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, GH3101 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 Excipient Grade Guanidine HCl 6M, GH3101 is manufactured in accordance with ICH Q7 compliant cGMP guidelines and is suitable for use “downstream” in the manufacture of drug products but not for use in further manufacturing of parenteral grade products. This grade of Guanidine HCl 6M is not sterile and requires terminal sterilization. It is not intended for use as an API, final Drug Product or Household item.

Expiration/Retest Date:

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

Storage and Shipping Conditions:

Ship and store in ambient temperature.

Package Sizes:

200L drums and 1135L totes.