ICH-Q7 GMP Manufactured Product
BIS-TRIS
*Low Bioburden, Low Endotoxin
BIS-TRIS is a zwitterionic biological “Goods” buffer often used in biological pharmaceutical manufacturing and biochemistry for extraction, separation and purification, as well as an intermediate in synthetic reactions for both proteins and nucleic acid. BIS-TRIS is also used as a process aid in peptide synthesis. It can also be used as a scavenger agent for metal ions such as Cu and Pb.
CAS #: 6976-37-0
Formula: C8H19NO5
pH @ 25°C: 6.3 - 6.7
Melting Point/Range: 100 - 105°C
F.W.: 209.24 g/mol
Product Specifications:
| Analysis | Specifications | ||
|---|---|---|---|
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≤ 0.04 a.u. ≤ 0.02 a.u. |
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White Crystalline Powder |
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99.0% - 101.0% |
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≤ 100 CFU/g |
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Chloride |
< 0.005% |
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Endotoxin |
≤ 50 EU/g | ||
|
None Detected None Detected None Detected |
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≤ 3ppm |
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Conforms to Reference Standard |
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≤ 3ppm |
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≤ 1.0% |
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|
Melting Point |
100 – 105°C |
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| pH (1% aqueous) |
8.8 – 9.8 |
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| pKa |
6.3 – 6.7 |
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|
Residue on Ignition (ROI) |
≤ 0.1% |
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Solubility 0.1M in H2O (USP) |
Clear and Complete | ||
|
Water (KF) |
≤ 1.0% |
Printable Version
General Product Description:
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The manufacturing of BIS-TRIS, BTRI-3250 is performed at BioSpectra’s Bangor, PA facility and is conducted in a multi-use processing area using only multi-use equipment.
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BIS-TRIS is a White Crystalline product
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Molecular Formula: C8H19NO5
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Molecular Weight: 209.24 g/mol
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CAS Number: 6976-37-0
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There are no known major food allergens (as defined by FDA and WHO) in the manufacture of this product.
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Biospectra certifies that all BIS-TRIS BTRI-3250 manufactured at BioSpectra and its raw materials are not derived from or come in contact with animal parts, products and/or byproducts. BIS-TRIS manufactured at BioSpectra and any raw materials used in the manufacture of BIS-TRIS at BioSpectra are not subject to genetic modification.
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Synonyms: 2,2-Bis(hydroxymethyl)-2,2’,2’’- nitrilotriethanol; Bis(2-hydroxyethyl) aminotris(hydroxymethyl)methane
GMP Compliance:
Bio Excipient Grade BIS-TRIS, BTRI-3250 is suitable for use as an excipient. It is manufactured in accordance with the ICH-Q7 Good Manufacturing Practice Guide. This grade of BIS-TRIS is not suitable to be used as an Active Pharmaceutical Ingredient, Drug Product or Household Item.
Residual Solvents Statement:
Based on the manufacturing process and the controlled handling, storage and analysis of this product, this product complies with the requirements and specifications listed in the current USP method <467> Tables 1, 2, 3, or 4.
Retest Date:
The recommended retest period for BIS-TRIS is 18 months from the date of manufacture.
Storage and Shipping Conditions:
Store in a cool, dry place. Store in a cool, dry, well-ventilated area away from incompatible substances. Keep away from acids. Keep containers tightly closed.
Package Sizes:
10kg, 25 kg and 50 kg pails.
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.