Excipient
ICH-Q7 GMP Manufactured ProductBIS-TRIS HCl, LBLE, GMP Excipient Grade
Low Bioburden, Low Endotoxin, GMP Manufactured
Product Code: BTHY-3250
Intended For Use As An Excipient
BIS-TRIS HCl, is the chlorinated version of BIS-TRIS, a zwitterionic biological buffer often used in biological pharmaceutical manufacturing for extraction, separation and purification, as well as an intermediate in synthetic reactions and as a process aid in peptide synthesis.
Product Specifications
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ANALYSIS |
SPECIFICATIONS |
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≤ 0.05 a.u. ≤ 0.03 a.u. |
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White Crystals | ||
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≥ 99.0% | ||
| Bioburden | ≤ 100 CFU/g | ||
| Endotoxin | ≤ 50 EU/g | ||
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None Detected None Detected None Detected |
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Passes Test |
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3.8 – 4.4 |
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Passes Test | ||
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≤ 1.0% |
| 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
BTHY-3250
CAS #: 124763-51-5
Formula: C8H19NO5·HCl
F.W.: 245.70 g/mol
General Product Description:
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The manufacturing of Bis-Tris HCl BTHY-3250 is performed at BioSpectra’s Bangor, PA facility and is conducted in a dedicated processing area using only dedicated equipment.
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Bis-Tris HCl is a White Crystalline product
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Molecular Formula: C8H19NO5 • HCl
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Molecular Weight: 245.70 g/mol
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CAS Number: 124763-51-5
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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 HCl BTHY-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 HCl manufactured at BioSpectra and any raw materials used in the manufacture of Bis-Tris HCl at BioSpectra are not subject to genetic modification.
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Synonyms: 2,2-Bis(hydroxymethyl)-2,2’,2”- nitrilotriethanol, BIS-TRIS hydrochloride, Bis(2- hydroxyethyl)aminotris(hydroxymethyl)methane, 2-Bis(2-hydroxyethyl)amino-2-(hydroxymethyl)-1,3- propanediol
GMP Compliance:
Bio Excipient Grade Bis-Tris HCl BTHY-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 HCl is not suitable to be used as an Active Pharmaceutical Ingredient, Drug Product or Household Item.
Retest Date:
The recommended retest period for Bis-Tris HCl is two years from the date of manufacture.
Storage and Shipping Conditions:
Keep container tightly closed in a dry and well-ventilated place.
Package Sizes:
10kg, 25 kg and 50 kg pails.
Additional Packaging Information
https://www.biospectra.us/technical/packaging