Guanidine Hydrochloride Parenteral Excipient LBLE

Excipient

ICH Q7 GMP Manufactured Product

Guanidine HCl

NF, LBLE*, GMP, Excipient
Product Code: GHCL-3253

*Low Bioburden, Low Endotoxin

Minimum Order Quantity: 500kg
Lead Time (if no stock): 1-month

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UNIT SIZE

QUANTITY

100g

500g

1kg

2-5kg

1x5kg

1x10kg

Total

Product Code: GHCL-3253

Suitable for use as a cGMP chemical in pharmaceutical manufacturing processes and products.

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

CAS #: 50-01-1
Formula: NH₂C(NH)NH₂ • HCl
Solubility: 215g/100g at 20^oC
F.W.: 95.53 g/mol
pH: 4.5 - 6.0

Product Specifications

ANALYSIS

SPECIFICATIONS

Acidity (NF)

< = 0.01%

Appearance and Color

White Crystals

Appearance of Solution (6M)

Clear and Colorless

Assay, Dried Basis (NF)

99.5% – 101.0%

Chloride

36.5 – 37.5%

Enzymes

DNase

Protease

RNase

None Detected

Identification A, IR (NF)

Conforms to Reference Standard

Identification B,

Absorbance (6M) (NF)

230 nm

235 nm

260 nm

275 nm

280 nm

< = 0.20 a.u.

< = 0.03 a.u.

< = 0.10 a.u.

Identification C, Chloride (NF)

Passes Test

Limit of Nitrate (NF)

< = 50 ppm

Loss on Drying (NF)

< = 0.5%

Melamine

< = 0.01%

Melting Range (NF)

184°C – 188°C

Microbial Content

TAMC

TYMC

Bile-tolerant gram-negative bacteria

Candida albicans

Escherichia coli

Pseudomonas aeruginosa

Salmonella

Staphylococcus aureus

< = 100 CFU/g

< = 10 CFU/g

Absent/g

Absent/10g

Absent/g

pH (6M)

4.5 – 6.0

pH (0.5M)

5.0 – 6.5

Residue on Ignition (NF)

< = 0.05%

Solubility (6M)

Passes Test

Sulfate (NF)

< = 50 ppm

Trace Metals

Arsenic (As)

Copper (Cu)

Iron (Fe)

Lead (Pb)

< = 5 ppm

Water Insoluble Substances (NF)

< = 0.05%

Water, KF

< = 0.5%

Printable Version

Key Product Features:

The manufacturing of Guanidine Hydrochloride, GHCL-3253 is performed at BioSpectra’s Stroudsburg, PA facility.
Appears as white crystals
Manufactured in accordance with ICH Q7
Manufactured in an enzyme free, hormone free, and animal free environment
Contains no known major food allergens (as defined by FDA and WHO)
The final product and its raw materials are not derived from nor come into contact with animal parts, animal products, and/or animal byproducts or derivatives.
Is not subject to genetic modification
Synonyms: Guanidine Monohydrochloride; Guanidinium Chloride; Guanidinium Hydrochloride.

Shelf-Life Policy:

Unless otherwise noted on the Shelf-Life Statement and CoA, this product has a 2-year retest date supported by a 3-year ICH Q1 Stability Study (if one is completed).

Storage & Shipping:

Refer to SDS.

Package Sizes:

10kg, 25kg, and 50kg

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.