Product Category

Buffer/ Excipient

ICH-Q7 GMP Manufactured Product

GUANIDINE HCl Buffer,
NF Grade, GMP Excipient Grade

Product Code: GHCL-3220 | Previously: GH3220

Intended For Critical Biopharma Applications


Guanidine Hydrochloride Buffer is a strong protein denaturant that functions as a chaotropic agent. As a denaturant, it acts to unfold proteins and turn them into their original polypeptide chains. As a chaotropic agent, it breaks down the structure of proteins. Guanidine Hydrochloride Buffer is commonly used in the purification of RNA by dissociating the RNA into its nucleic acids and protein forms. At higher concentrations, Guanidine Hydrochloride Buffer decreases enzyme activity. It is also used to increase the solubility of hydrophobic molecules.

Product Specifications

ANALYSIS SPECIFICATIONS
 Acidity

≤0.01%

Appearance and Color  
White / Crystals
Assay (Dried Basis)  
99.5% - 101.0%
Chloride and Sulfate, Sulfate

≤0.005%

Enzymes

DNase

Protease

RNase

None Detected
None Detected
None Detected
Identification A (IR)  
Passes Test

Identification B, Absorbance

230 nm
260 nm
275 nm

≤ 0.2000 a.u.

≤ 0.0300 a.u.

≤ 0.0300 a.u.

Identification C – Chloride

Meets the Requirement of Test A

Limit of Nitrate

≤0.005%
Loss on Drying ≤0.5%
Melting Range  

184ºC-188ºC

pH (6M)  
4.5 – 6.0
Residue on Ignition  
≤0.05%
Solubility (6M)  
Passes Test
Trace Metals

Arsenic (As)

Copper (Cu)

Iron (Fe)

Lead (Pb)

≤ 5 ppm

≤ 5 ppm

≤ 5 ppm

≤ 5 ppm

Water by Karl Fischer

NMT 0.3%w/w

Water Insoluble

≤0.05%

List of C of As files
GHCL-0124-00007_GHCL-3220.pdf
GHCL-0223-00066_GHCL-3220.pdf
GHCL-0223-00040_GHCL-3220-25.pdf
GHCL-0123-00033_GHCL-3220.pdf
GHCL-0223-00009_GHCL-3220.pdf
GHCL-0223-00009_GHCL-3220-25.pdf
GHCL-0223-00017_GHCL-3220-25.pdf
GHCL-0123-00015_GHCL-3220.pdf
GHCL-0122-00167_GHCL-3220.pdf
GHCL-0122-00118_GHCL-3220.pdf
GHCL-0122-00111_GHCL-3220.pdf
GHCL-0122-00110_GHCL-3220.pdf
GHCL-0122-00109_GHCL-3220 500g.pdf
GHCL-0122-00109_GHCL-3220.pdf
GHCL-0222-00106_GHCL-3220.pdf
GHCL-0122-00101_GHCL-3220.pdf
GHCL-0122-00008_GHCL-3220.pdf
GHCL-0122-00007_GHCL-3220.pdf
GHCL-0021-00107_GHCL-3220.pdf
GHCL-0221-00102_GHCL-3220.pdf
GHCL-0121-00090_GHCL-3220.pdf
GHCL-0121-00086_GHCL-3220.pdf
GHCL-0121-00081_GHCL-3220.pdf
GHCL-0121-00074_GHCL-3220.pdf
GHCL-0121-00073_GHCL-3220.pdf
GHCL-0121-00072_GHCL-3220.pdf
GHCL-0121-00067_GHCL-3220.pdf
GHCL-0121-00066_GHCL-3220.pdf
GHCL-0121-00068_GHCL-3220.pdf
GHCL-0121-00061_GHCL-3220.pdf
GHCL-0121-00060_GHCL-3220.pdf
GHCL-0121-00041_GHCL-3220.pdf
GHCL-0121-00034_GHCL-3220.pdf
GHCL-0121-00013_GHCL-3220.pdf
GH3220-033-0121.pdf
GH3220-037-0221.pdf
GH3220-036-0221.pdf
GH3220-035-0221.pdf
GH3220-034-0121.pdf
GH3220-032-1120.pdf
GH3220-031-1020 K001.pdf
GH3220-031-1020 G500.pdf
GH3220-030-1020 K001.pdf
GH3220-030-1020 G500.pdf
GH3220-029-1020 K001.pdf
GH3220-029-1020 G500.pdf
GH3220-028-0920.pdf
GH3220-027-0920.pdf
GH3220-026-0820.pdf
GH3220-025-0820.pdf
GH3220-024-0820.pdf
GH3220-021-0820.pdf
GH3220-022-0820.pdf
GH3220-023-0820.pdf
GH3220-020-0720.pdf
GH3220-019-0720.pdf
GH3220-005-1018.pdf
GH3220-018-0520.pdf
GH3220-017-0519.pdf
GH3220-016-0519.pdf
GH3220-015-0519.pdf
GH3220-011-0419.pdf
GH3220-010-0419.pdf
GH3220-014-0419.pdf
GH3220-012-0419.pdf
GH3220-013-0419.pdf
GH3220-009-0219.pdf
GH3220-008-0219.pdf
GH3220-007-0219.pdf
GH3220-006-0119.pdf
GH3220-004-1018.pdf
GH3220-001-0118.pdf

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General Product Description:

  • The manufacturing of Guanidine Hydrochloride Buffer GHCL-3220 is performed at BioSpectra’s Stroudsburg, PA facility and is conducted in a dedicated processing area using only dedicated equipment.
  • Guanidine HCl Buffer is a White Crystalline product.
  • Molecular Formula: NH2C(NH)NH2HCl.
  • Molecular Weight: 95.53 g/mol.
  • CAS Number: 50-01-1.
  • 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 Buffer GHCL-3220 manufactured at BioSpectra and its raw materials are not derived from or come in contact with animal parts, products, and/or byproducts.
  • Guanidine Hydrochloride Buffer manufactured at BioSpectra and any raw materials used in the manufacture of Guanidine Hydrochloride Buffer at BioSpectra are not subject to genetic modification.
  • Synonyms: Guanidine Monohydrochloride, Guanidinium Chloride, Guanidinium Hydrochloride Buffer.


GMP Compliance:

Bio Excipient Grade Guanidine Hydrochloride Buffer, GHCL-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 Hydrochloride Buffer 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 Buffer is two years from the date of manufacture.

Storage and Shipping Conditions:

Ship and Store in ambient temperature.

Package Sizes:

10kg, 25 kg and 50 kg pails.

Additional Packaging Information

https://www.biospectra.us/technical/packaging