Product Category


ICH-Q7 GMP Manufactured Product

LBLE, GMP Excipient Grade

Low Bioburden, Low Endotoxin, GMP Manufactured

Product Code: GHCL-3253

Intended For Critical Biopharma Applications

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 inthe 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.

Product Specifications


280 nm, 6 mol/l, 1 cm, water
275 nm, 6 mol/l, 1 cm, water
260 nm, 6 mol/l, 1 cm, water
235 nm, 6 mol/l, 1 cm, water
230 nm, 6 mol/l, 1 cm, water

≤ 0.10 a.u.
≤ 0.03 a.u.
≤ 0.03 a.u.
≤ 0.20 a.u.
≤ 0.20 a.u.

Appearance and Color  
White / Crystals

Appearance of solution (6 mol/l; water)


Clear and colorless



≥ 99.5 %

Bacterial Endotoxins


≤ 2.5 I.U./g

Chloride (Cl) (argentometric)


36.5 – 37.5 %



None Detected
None Detected
None Detected

Heavy Metals (as Pb)


≤ 10 ppm

Identification (IR)


Passes Test

Insoluble Matter


≤ 0.15 %

Loss on Drying


≤ 0.5 %

Melamine (HPLC)


≤ 0.01 %

Melting Range


184 – 188°C



≤ 0.005%

pH (6M)


4.5 – 6.0

pH (0.5 mol/l, water)


5.0 – 6.5

Residue on Ignition

 ≤ 0.05%
Solubility (6M)  Passes Test
Sulfate  0.01% max.
Sulfated ash (600 °C)  ≤ 0.05 %

≤ 100 CFU/g

TYMC  ≤ 10 CFU/g
Bile-tolerant gram-negative bacteria (absent in 1 g)

Passes Test

Candida albicans (absent in 1 g)

Passes Test

Escherichia coli (absent in 1 g)

Passes Test

Pseudomonas aeruginosa (absent in 1 g)

Passes Test

Salmonella (absent in 10 g)

Passes Test

Staphylococcus aureus (absent in 1 g) Passes Test

Trace Metals

Arsenic (As)
Copper (Cu)
Iron (Fe)
Lead (Pb)

≤ 5 ppm
≤ 5 ppm
≤ 5 ppm
≤ 5 ppm

Water (according to Karl Fischer) ≤ 0.5 %

Residual solvents (ICH (Q3C)) excluded by manufacturing process.
Elemental impurity specifications have been set considering ICH Q3D (Guideline for Elemental Impurities). Class 1-3 elements are not likely to be present above the ICH Q3D option 1 limit, unless specified and indicated (*).

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.

Key Compliance Attributes of BioSpectra Grades Bio Excipient Grade ICH-Q7 Compliant Manufactured
Suitable for Research and Diagnostic  
Each Batch 100% Analyzed  
Management of Change  
Validated Analytical Methods  
Compendial Testing  
Trace Metals Analyzed  
Stability Testing Program  
BioSpectra Supply Chain Audit Trail  
Product Origin Statement  
Customer Quality Audits  
Validated Manufacturing Process  
US Manufactured at BioSpectra  
Customized Additional Specifications  
Multi-Compendial Testing  
Low Bioburden Low Endotoxin (LBLE)  
Enzyme Tested  
Suitable for use as Excipient  
Microbial / Endotoxin Tested  
Manufactured in FDA Registered Facility  
Customized Manufacturing Schedule  
Custom Regulatory Packet  
Accelerated Stability  
Video Conference access to BioSpectra Sites  
Complete access to Product Traceability  
Access to Supply Chain Information  
ICH-Q7 Qualified Utilities  
ICH-Q7 Compliant Manufactured  
Type II Drug Master File  

Yes-imageindicates an attribute or level of compliance which is granted or available based on the purchase of the product grade.
Bio Excipient Grade: Intended for use as ICH-Q7 Compliant Active Pharmaceutical Ingredient 
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.


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General Product Description:

  • The manufacturing of Guanidine Hydrochloride GHCL-3253 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: CH5N3 • 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 GHCL-3253 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.

GMP Compliance:

Bio Excipient Grade Guanidine Hydrochloride, GHCL- 3253 is suitable for use as an excipient. It is manufactured in accordance with the ICH-Q7 Good Manufacturing Practice Guide. This grade of Guanidine Hydrochloride is not suitable to be used as an Active Pharmaceutical Ingredient, Drug Product or Household Item.

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.

Additional Packaging Information