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Product Category

GMP Solution

GMP Manufactured Process Chemical

Guanidine HCl 6M, GMP Grade

Product Code: GHCL-4120 | Previously: GH4120

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Intended For Critical Biopharma Applications


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.

Product Specifications

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-image
Each Batch 100% Analyzed  
Yes-image
Management of Change  
Yes-image
Validated Analytical Methods  
Yes-image
Compendial Testing  
Yes-image
Trace Metals Analyzed  
Yes-image
Stability Testing Program  
Yes-image
BioSpectra Supply Chain Audit Trail  
Yes-image
Product Origin Statement  
Yes-image
Customer Quality Audits  
Yes-image
Validated Manufacturing Process  
Yes-image
US Manufactured at BioSpectra  
Yes-image
IPEC cGMP Compliant Manufactured  
Yes-image
Customized Additional Specifications Yes-image
Multi-Compendial Testing  
Yes-image
Low Bioburden Low Endotoxin (LBLE)  
Yes-image
Enzyme Tested  
Yes-image
Suitable for use as Excipient  
Yes-image
Microbial / Endotoxin Tested  
Yes-image
Manufactured in FDA Registered Facility  
Yes-image
Customized Manufacturing Schedule  
Yes-image
Custom Regulatory Packet  
Yes-image
Accelerated Stability  
Yes-image
Video Conference access to BioSpectra Sites  
Yes-image
Complete access to Product Traceability  
Yes-image
Access to Supply Chain Information  
Yes-image

Yes-imageindicates an attribute or level of compliance which is granted or available based on the purchase of the product grade.
Bio Pharma Grade: Intended for use as IPEC cGMP Compliant Chemical
LBLE: LBLE applies when product specifications include requirements for Bioburden Testing (TAMC/TYMC and/or Endotoxin).
LBLE stands for Low Bioburden, Low Endotoxin non-sterile products suitable for further use in parenteral manufacturing and other sterile applications.

 

List of C of As files
GH4120-002-0916.pdf
GH4120-003-1116.pdf
GH4120-004-1116.pdf

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COAs and Tech Docs

Product-image
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GHCL-4120

CAS #: 50-01-1

Formula: CH5N3 • HCl

Sol. In H20 (g/L): 573
F.W.: 95.53 g/mol
pH @ 20oC: 4.5 - 6.0
pKa @ 25oC: 13.6

General Product Description:

  • The manufacturing of Guanidine Hydrochloride GHCL-4120 is performed at BioSpectra’s Stroudsburg, PA facility utilizing dedicated equipment. Equipment used in the manufacturing of GHCL-4120 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 GHCL-4120 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, GHCL-4120 is suitable for use as a process chemical. It is manufactured in accordance with the IPEC- PQG Joint Good Manufacturing Practice Guide. This grade of Guanidine Hydrochloride is not suitable to be used as an Active Pharmaceutical Ingredient, Drug, Drug Product or Household Item.

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.

Additional Packaging Information

https://www.biospectra.us/technical/packaging