Excipient
ICH-Q7 GMP Manufactured ProductBIS-TRIS, LBLE, GMP Excipient Grade
Low Bioburden, Low Endotoxin, Multicompendial, GMP Manufactured
Product Code: BTRI-3250
Intended For Use As An Excipient
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.
Product Specifications
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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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Bioburden |
≤ 100 CFU/g |
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Chloride |
< 0.005% |
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Endotoxin |
≤ 50 EU/g | ||
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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 @ 25°C |
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 + complete | ||
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Water (KF) |
≤ 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. |
COAs and Tech Docs
- Printable Spec Sheet
- Product Inquiry
- Compliance
- C of As
- SDS
- Elemental Impurities
- Regulatory Packet
- Process Flow Diagram
- GMP Statement
- Animal Origin Statement
- BSE/TSE
- Allergen
- Mycotoxin/Aflatoxin
- GMO Statement
- Melamine
- Residual Solvents
- Gluten Free
- Ingredient Declaration
- Prop 65
- Supply Chain
- Imidazole
- Formaldehyde
- Slip Agent Statement
- Nitrosamine Statement
- Genotoxic Impurities
- Phthalate, Bisphenol, Dioxin
- Catalyst
- Test Methods
- IRGAFOS
- Degradation and Impurity
- Label Copy
- Sample COA
- Shelf Life Statement
- TUPP Statement
BTRI-3250
CAS #: 6976-37-0
Formula: C8H19NO5
Melting Point/Range: 100 - 105°C
F.W.: 209.24 g/mol
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 dedicated processing area using only dedicated 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 two years 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.
Additional Packaging Information
https://www.biospectra.us/technical/packaging