Product Category

Excipient

ICH-Q7 GMP Manufactured Product

GUANIDINE THIOCYANATE
GMP Excipient Grade

Product Code: GTHI-3220 | Previously: GT3220

Intended For Use As An Excipient


Guanidine Thiocyanate is a chaotropic agent. As one of the strongest protein denaturants, it inactivates nucleases more than twice as fast as Guanidine Hydrochloride. Guanidine Thiocyanate is preferred for the purification of RNA because it dissociates the RNA into its nucleic acids and protein forms. Higher molarity solutions of Guanidine Thiocyanate irreversibly inactivate RNase. Guanidine Thiocyanate causes proteins to dissolve readily, thus disintegrating cellular structures.

Product Specifications

ANALYSIS SPECIFICATIONS
  280 nm
Absorbance 300 nm
  340 nm
0.300 a.u. maximum
0.050 a.u. maximum
0.030 a.u. maximum
Appearance and Color  
White / Crystals
Assay  
99.5% minium.
Enzymes

DNase

Protease

RNase

None Detected
None Detected
None Detected
Identity (IR)  
Passes Test

Loss on Drying

 
0.5% max.
Melting Range  

115-121ºC

pH (5% solution)  
5.0-7.0
Solubility (35%)  
Passes Test
Trace Metals

Arsenic (As)

Copper (Cu)

Iron (Fe)

Lead (Pb)

5 ppm max.
5 ppm max.
5 ppm max.
5 ppm max.
Printable Version

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General Product Description:

  • BioSpectra manufactures Bio Excipient Grade Guanidine Thiocyanate GTHI-3220 in its Bangor, PA facility. Guanidine Thiocyanate is packaged, stored, tested, and released at BioSpectra’s Bangor, PA facility.
  • Guanidine Thiocyanate is a White Crystalline product. Molecular Formula: C2H6N4S.
  • Molecular Weight: 118.16 g/mol.
  • CAS Number: 593-84-0.
  • There are no known major food allergens (as defined by FDA and WHO) in the manufacture of this product.
  • BioSpectra certifies that all Guanidine Thiocyanate GTHI-3220 manufactured at BioSpectra and its raw materials are not derived from or come in contact with animal parts, products, and/or byproducts.
  • Guanidine Thiocyanate manufactured at BioSpectra and any raw materials used in the manufacture of Guanidine Thiocyanate at BioSpectra are not subject to genetic modification.
  • Synonyms: Guanidine Hydrothiocyanate, Guanidine Isothiocyanate, Guanidine Monothiocyanate.

 



GMP Compliance:

Bio Excipient Grade Guanidine Thiocyanate GTHI-3220 is suitable for use as an excipient. It is manufactured in accordance with the ICH-Q7 Good Manufacturing Practice Guide. This grade of Guanidine Thiocyanate is not suitable to be used as an Active Pharmaceutical Ingredient, Drug Product or Household Item.

Pictograms: 

Signal word: Danger

Hazardous Statements:

H302 – Harmful if swallowed
H312 – Harmful in contact with skin
H314 – Causes severe skin burns and eye damage
H332 – Harmful if inhaled
H412 – Harmful to aquatic life with long lasting effects
EUH032 – Contact with acids liberates very toxic gas
EUH071 – Corrosive to the respiratory tract

Retest Date:

The recommended retest period for Guanidine Thiocyanate is two years from the date of manufacture.

Storage and Shipping Conditions:

Ship and Store in ambient temperature.

Package Sizes:

10kg, 25kg and 50kg pails.

Additional Packaging Information

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