ICH Q7 GMP Manufactured Product
Meets USP/EP/JP/ChP, BET*, GMP
Product Code: GLYS-3150
*Bioburden and Endotoxin Tested
Minimum Order Quantity: Inquire
Lead Time: Inquire
Glycerin, Synthetic, USP, EP, BP, JP, ChP, is a fully synthetic, Excipient Grade Product, manufactured, packaged, labeled, and tested in FDA registered and inspected cGMP facility in Bangor PA, USA. All operations are conducted in compliance with current Good Manufacturing Practices (cGMP) as defined by 21 CFR Parts 210 and 211 and ICH Q7 Guidance. This product is suitable for use in Insulin manufacturing and other critical pharmaceutical preparations.
CAS #: 56-81-5
Formula: C3H8O3
F.W.: 92.09 g/mol
|
ANALYSIS |
SPECIFICATIONS |
|---|---|
| Acidity or Alkalinity (ChP/EP/JP) | Passes Test |
|
< = 10 ppm Passes Test |
|
|
< = 5 ppm < = 5 ppm < = 5 ppm < = 2 ppm |
|
| Acrolein, glucose, or other reducing substances (JP) | Passes Test |
| Ammonium (ChP/JP) | Passes Test |
| Appearance and Color | Clear, Colorless, Viscous Liquid |
| Appearance of Solution (EP) | Clear, Colorless Solution |
| Arsenic (ChP/JP) | < = 0.3 ppm |
| Assay, Anhydrous Basis (USP/EP/ChP/JP) | 99.8 - 101.0% |
| Endotoxin (ChP) | < = 10 EU/g |
| Calcium (ChP/JP) | Passes Test |
| Chloride (USP/EP/JP/ChP) | < = 6 ppm |
| Color (USP/JP/ChP) | Passes Test |
|
Passes Test Passes Test |
|
| Halogenated Compounds (EP/ChP) | < = 30 ppm |
| Limit of Chlorinated Compounds (USP) | < = 30 ppm of Cl |
| Heavy Metals (Pb) (ChP/JP) | < = 2 ppm |
| Identification, IR (USP-A/EP-B/ChP/JP) | Conforms to Reference Standard |
| Identification C (USP) | Conforms to Reference Standard |
| Iron (ChP) | < = 0.5 ppm |
|
< 50 CFU/g < 50 CFU/g Absent/g |
|
| Purity | > = 99.7% |
| < = 3000 ppm | |
| Readily Carbonizable Substances (ChP/JP) | Passes Test |
| Refractive Index, 20°C (EP-A/ChP) | 1.470 - 1.475 |
| Residue on Ignition / Sulfated Ash (USP/EP/ChP/JP) | < = 0.01% |
|
> = 1.249 1.258 - 1.268 |
|
| Sugars (EP/ChP) | Passes Test |
| Sulfate (USP/ChP/JP) | < 20 ppm |
| Water, KF (USP/EP/ChP/JP) | < = 2.0% |
The manufacturing of Synthetic Parenteral Glycerin is performed at BioSpectra's Bangor, PA facility.
Appears as a clear, colorless, viscous liquid
Manufactured in accordance with ICH Q7
Is not subject to genetic modification
Manufactured in a 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.
Refer to SDS.
6x 1L, 4x 4L, 10L, 200L, 1,000L
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.