Excipient
ICH-Q7 GMP Manufactured ProductGUANIDINE 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
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White / Crystals | |||||||||
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99.5% minium. | |||||||||
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None Detected None Detected None Detected |
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Passes Test | |||||||||
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0.5% max. | |||||||||
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115-121ºC |
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5.0-7.0 | |||||||||
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Passes Test | |||||||||
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5 ppm max. 5 ppm max. 5 ppm max. 5 ppm max. |
| Key Compliance Attributes of BioSpectra Grades | Bio Excipient Grade ICH-Q7 Compliant Manufactured | ||
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| indicates 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. |
COAs and Tech Docs
- Printable Spec Sheet
- Product Inquiry
- Compliance
- C of As
- SDS
- Regulatory Packet
- Process Flow Diagram
- GMP Statement
- Animal Origin Statement
- BSE/TSE
- Allergen
- Mycotoxin/Aflatoxin
- GMO Statement
- Melamine
- Residual Solvents
- Gluten Free
- Ingredient Declaration
- Prop 65
- Stability Data Statement
- Supply Chain
- Imidazole
- TUPP Report - Stroudsburg
- Formaldehyde
- Slip Agent Statement
- Genotoxic Impurities
- Phthalate, Bisphenol, Dioxin
- Catalyst
- Test Methods
- IRGAFOS
- Degradation and Impurity
- Stability Report
- Nitrosamine Risk Assessment
- Elemental Impurity Assessment
- Label Copy
- Certificate of Origin
GTHI-3220
CAS #: 593-84-0
Formula: C2H6N4S
Sol. In H2O (g/L): 1,600
F.W.: 118.16 g/mol
pH @ 20°C: 5.0 - 7.0
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