ICH-Q7 GMP Manufactured Product
Guanidine HCL (6M) Solution
Guanidine Hydrochloride 6M Buffer 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 Buffer Solution is also used to break the hydrogen bonds in the structure of proteins and increase the solubility of hydrophobic molecules.
CAS #: 50-01-1
Formula: CH5 N3 • HCl
Sol. In H2O (g/L): 573 @ 20°C
F.W.: 95.53 g/mol
pH @ 20°C: 4.5 - 6.5
Product Specifications
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ANALYSIS |
SPECIFICATIONS |
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|---|---|---|---|
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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 |
Printable Version
General Product Description:
- The manufacturing of Bio Excipient Grade Guanidine Hydrochloride 6M Buffer Solution, GHCL-3101 is performed at BioSpectra’s Bangor, PA facility and is conducted in a dedicated processing area using only dedicated equipment. Cleaning verification is performed on the dedicated manufacturing equipment.
- Molecular Formula: CH5N3 • HCl
- Molecular Weight: 95.53 g/mol.
- CAS #: 50-01-1
- Guanidine Hydrochloride 6M Buffer Solution 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 Buffer Solution, GHCL-3101 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 Buffer Solution manufactured at BioSpectra and any raw materials used in the manufacture of Guanidine Hydrochloride 6M Buffer Solution at BioSpectra are not subject to genetic modification.
- Synonyms: Guanidine Monohydrochloride, Guanidinium Chloride, Guanidinium Hydrochloride Buffer Solution.
- Manufactured with USP grade purified water.
GMP Compliance:
Bio Excipient Grade Guanidine HCl 6M Buffer Solution, GHCL-3101 is suitable for use as an excipient. It is manufactured in accordance with the ICH-Q7 Good Manufacturing Practice Guide. This grade of Guanidine HCl 6M Buffer Solution 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 6M Buffer 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.
Bulk GMP Fine Chemicals exclusively manufactured in North America
American Manufactured - FDA Registered GMP Facilities: Parenteral Excipients, GMP Small Molecule Intermediates, GMP Biological Buffers, Parenteral Carbohydrates, GMP Chlorinated Amino Acids, GMP Solutions in Sterile Single Use Packaging and other Reagent & GMP Fine Chemicals.