GMP Solution
ICH-Q7 GMP Manufactured ProductGuanidine HCl 6M GMP Solution with 50mM Sodium Phosphate
Made with USP WFI & Compendial Na Phosphate
Sterile Filtered/ Sterile, Single-Use 200L Drum
Product Code: GHCP-3101
Intended For Critical Biopharma Applications
Guanidine Hydrochloride 6M/50 mM Na-Phosphate 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.
Product Specifications
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ANALYSIS |
SPECIFICATIONS |
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Clear liquid free from particles | ||
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Colorless | ||
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48.20 to 58.80 mS/cm | ||
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Complies | ||
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≤ 10 ppm | ||
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Complies | ||
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Complies | ||
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5.9 to 6.1 mol/L |
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| Osmolality (1:20 dilution) |
519 to 575 mOsm/kg |
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| pH |
6.9 to 7.1 |
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| Purity (at 260 nm) |
≤ 0.10 ABS |
| 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. |
| List of C of As files |
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| No files available right now. |
COAs and Tech Docs
- Printable Spec Sheet
- Product Inquiry
- Compliance
- C of As
- SDS
GHCP-3101
CAS #: 50-01-1
Formula: (Guan HCl)6M/L(NaPO4)50mM/L
Sol. In H2O (g/L): 573 @ 20°C
F.W.: 95.53 g/mol
pH @ 20°C: 4.5 - 6.5
General Product Description:
- The manufacturing of Bio Excipient Grade Guanidine Hydrochloride 6M/50 mM Na-Phosphate solution, GHCP-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: (Guan HCl)6M/L(NaPO4)50mM/L
- Molecular Weight: 95.53 g/mol.
- CAS #: 50-01-1
- Guanidine Hydrochloride 6M/50 mM Na-Phosphate 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/50 mM Na-Phosphate solution, GHCP-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 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:
Guanidine HCl 6M/50 mM Na-Phosphate solution, GHCP-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 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/50 mM Na-Phosphate 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.
200L BAG WITH OUTER PE DRUM
Additional Packaging Information
https://www.biospectra.us/technical/packaging