Guanidine Thiocyanate - Excipient

BIO EXCIPIENT GRADE | GT3220 | CAS#: 593-84-0

INTENDED FOR USE AS AN EXCIPIENT

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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.


These are general specifications. BioSpectra will customize our products to meet your quality based requirements.

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BIO EXCIPIENT GRADE / GT3220

CAS #: 593-84-0

Molecular Formula:

C2H6N4S

Solubility in Water (g/L): 1,600

F.W.: 118.16 g/mol

pH @ 20°C: 5.0 - 7.0

 

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
Key Compliance Attributes of BioSpectra Grades Bio Excipient Grade 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
Two Year Stability  
Yes
BioSpectra Supply Chain Audit Trail  
Yes
Product Origin Statement  
Yes
Customer Quality Audits  
Yes
Customized Additional Specifications  
Yes
Multi-Compendial Testing  
Yes
Enzyme Tested  
Yes
Validated Manufacturing Process  
Yes
US Manufactured at BioSpectra  
Yes
IPEC cGMP Compliant Manufactured  
Yes
Suitable for use as Excipient  
Available
Microbial / Endotoxin Tested  
Available
Manufactured in FDA Registered Facility  
Available
Customized Manufacturing Schedule  
Available
Custom Regulatory Packet  
Available
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
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General Product Description:

• BioSpectra manufactures Bio Excipient Grade Guanidine
Thiocyanate GT3220 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 GT3220
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 GT3220 is
manufactured in accordance with cGMP guidelines and is suitable
to be used only as the following: ICH Q7 Compliant cGMP
Manufactured Excipient for use in further Manufacturing. This
Grade of Guanidine Thiocyanate is not suitable to be used as an
Active Pharmaceutical Ingredient, Drug Product or household item.

Expiration/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.