GUANIDINE HCl 6M
BIO EXCIPIENT GRADE | GH3101
INTENDED FOR CRITICAL BIOPHARMA APPLICATIONS


BIO EXCIPIENT GRADE | GH3101
CAS #: 50-01-1
Molecular Formula:
CH5 N3 • HCl
Solubility in Water (g/L): 573 @ 20°C
F.W.: 95.53 g/mol
pH @ 20°C: 4.5 - 6.5
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Guanidine Hydrochloride 6M solution can be used to denature proteins which become randomly coiled with no residual structure. This concentration is also used to decrease enzyme activity. The denatured proteins can be modified or analyzed using mass spectrometry, electrophoresis and enzymatic digests. As a chaotropic agent, Guanidine Hydrochloride solution is also used to break the hydrogen bonds in the structure of proteins and increase the solubility of hydrophobic molecules.
These are general specifications. BioSpectra will customize our products to meet your quality based requirements.
ANALYSIS |
SPECIFICATIONS |
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0.1 a.u. max. | ||
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Clear, Colorless Liquid | ||
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Passes Test | ||
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≤ 10 ppm | ||
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Passes Test | ||
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≤ 3 ppm |
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5.8 – 6.2M | ||
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4.5 – 6.5 |
Key Compliance Attributes of BioSpectra Grades | Bio Excipient Grade ICH Q7 Compliant Manufactured | ||
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Yes | ||
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Available | ||
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List of C of As files |
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No files available right now. |
General Product Description:
- The manufacturing of Bio Excipient Grade Guanidine Hydrochloride 6M, GH3101 is performed at BioSpectra’s Bangor, PA facility and is conducted in a dedicated processing area using only dedicated equipment.
- Equipment used in the manufacturing of GH3101 is cleaned in accordance with BioSpectra’s Cleaning Validation Plan.
- Molecular Formula: CH5N3 • HCl
- Molecular Weight: 95.53 g/mol.
- CAS #: 50-01-1
- Guanidine Hydrochloride 6M is a clear colorless solution.
- 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 6M, GH3101 manufactured at BioSpectra and its raw materials are not derived from or come in contact with animal parts, products and/or byproducts.
- Guanidine Hydrochloride 6M manufactured at BioSpectra and any raw materials used in the manufacture of Guanidine Hydrochloride 6M at BioSpectra are not subject to genetic modification.
- Synonyms: Guanidine Monohydrochloride, Guanidinium Chloride, Guanidinium Hydrochloride.
- Manufactured with USP grade purified water.
GMP Compliance:
Bio Excipient Grade Guanidine HCl 6M, GH3101 is manufactured in accordance with ICH Q7 compliant cGMP guidelines and is suitable for use “downstream” in the manufacture of drug products but not for use in further manufacturing of parenteral grade products. This grade of Guanidine HCl 6M is not sterile and requires terminal sterilization. It is not intended for use as an API, final Drug Product or Household item.
Expiration/Retest Date:
The recommended retest period for Guanidine Hydrochloride 6M solution is two years from the date of manufacture.
Storage and Shipping Conditions:
Ship and store in ambient temperature.
Package Sizes:
200L drums and 1135L totes.