GUANIDINE HCl, LBLE

BIO EXCIPIENT GRADE | GH3250

C of As and Tech Docs

INTENDED FOR CRITICAL BIOPHARMA APPLICATIONS

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BIO EXCIPIENT GRADE / GH3250

CAS #: 50-01-1

Molecular Formula:

CH5N3 • HCl

Solubility in Water (g/L): 573

F.W.: 95.53 g/mol

pKa @ 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

0.1500 a.u. max.

0.0300 a.u. max.

0.0300 a.u. max.
Appearance and Color  
White / Crystals
Assay  
99.5% min.
Endotoxin  
≤ 50 EU/g
Enzymes

DNase

Protease

RNase
None Detected
None Detected
None Detected
Identification (FTIR)  
Passes Test
Identification (Chloride)  
Passes Test
Insoluble Matter  
0.15% max.

Loss on Drying

  
0.5% max.

Melting Range

  
184-188oC
Microbial Content

TAMC

TYMC
≤ 100 CFU/g
≤ 100 CFU/g
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.
Printable Version
Key Compliance Attributes of BioSpectra Grades Bio Excipient 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
Stability Testing Program  
Yes
BioSpectra Supply Chain Audit Trail  
Yes
Product Origin Statement  
Yes
Customer Quality Audits  
Yes
Validated Manufacturing Process  
Yes
US Manufactured at BioSpectra  
Yes
IPEC cGMP Compliant Manufactured  
Yes
Customized Additional Specifications  
Yes
Multi-Compendial Testing  
Available
Enzyme Tested  
Available
Suitable for use as Excipient  
Yes
Microbial / Endotoxin Tested  
Yes
Manufactured in FDA Registered Facility  
Yes
Customized Manufacturing Schedule  
Available
Custom Regulatory Packet  
Yes
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
Suitable for use as Active Ingredient  
No
Type II Drug Master File  
No
List of C of As files
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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 GH3250 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: CH 5N 3 .HCL
  • 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 GH3250 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.

RESIDUAL SOLVENTS: Based on the manufacturing process and the controlled handling, storage and analysis of this product, this product complies with the requirements and specifications listed in the current USP method <467> Tables 1, 2, 3, or 4.

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. Store in a clean and dry area. Store in the original container.

Package Sizes:

10kg, 25 kg and 50 kg pails.