Excipient
ICH-Q7 GMP Manufactured ProductTROMETHAMINE (TRIS)
USP, EP, LBLE, GMP Excipient Grade
Low Bioburden, Low Endotoxin, Multicompendial, GMP Manufactured
Product Code: TRIS-3255 | Previously: TR3255
Intended Use Statement
Tromethamine (Tris), is commonly used as a buffer and excipient in biological applications downstream in the manufacture of drug products. Tris is considered a “Good’s” buffer because it has low UV absorptivity, minimal reactivity, stable pH and is soluble in water.
Product Specifications
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ANALYSIS |
SPECIFICATIONS (USP) |
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White, crystalline powder to needle-like crystals | |||
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99.0-101.0% | |||
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Passes Test | |||
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Passes Test | |||
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Passes Test | |||
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1.0% max. | |||
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168-172oC | |||
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10.0-11.5 | |||
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0.1% max. |
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ANALYSIS |
SPECIFICATIONS (EP) |
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Passes Test | ||
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99.0-100.5% | ||
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≤ 100ppm | ||
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Passes Test | ||
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168-172°C | ||
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Passes Test | ||
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Passes Test | ||
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10ppm max. | ||
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0.5% max. | ||
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10.0-11.5 | ||
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≤ 1.0% | ||
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0.1% max. |
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ANALYSIS |
SPECIFICATIONS (JPC) |
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1.6 ppm max. | |||
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99.0-101.0% | |||
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Passes Test | |||
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8 ppm max. | |||
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Passes Test | |||
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Passes Test | |||
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0.5% max. | |||
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168-172oC | |||
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10.3-10.7 | |||
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0.1% max. |
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ANALYSIS |
SPECIFICATIONS (Other) |
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0.06 a.u. max. 0.06 a.u. max. 0.01 a.u. max. |
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0.03 a.u. max. 0.02 a.u. max. 0.004 a.u. max. |
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0.2 a.u. max. |
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20 APHA max. |
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99.9% min |
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≤ 2.5 EU/g |
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None Detected None Detected None Detected |
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1ppm max. |
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0.005% max. |
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1.0% max. |
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0.3% max. |
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≤ 100 CFU/g ≤ 100 CFU/g |
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0.1% max. |
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0.05% max. |
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< 1.6 ppm |
| 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
- NAFTA Statement
- REACH
- Prop 65
- Stability Data Statement
- Supply Chain
- Imidazole
- TUPP
- Formaldehyde
- Slip Agent Statement
- Nitrosamine Statement
- Genotoxic Impurities
- Phthalate, Bisphenol, Dioxin
- Test Methods
- IRGAFOS
- Stability Report
- Antiblock Additive Statement
- Nitrosamine Risk Assessment
- Label Copy
TRIS-3255 | TR3255
CAS #: 77-86-1
Formula: C4H11NO3
Sol. In H20 @ 25°C (g/L): 550
F.W.: 121.14 g/mol
pH @ 20°C 5% aq.: 10.0 - 11.5
Useful pH: 7.0 - 9.0
pKa @ 20˚C: 8.3
General Product Description:
- The manufacturing of Tromethamine TRIS-3255 is performed at BioSpectra’s Stroudsburg, PA facility and is conducted in a dedicated processing area using only dedicated equipment.
- Tromethamine is a White Crystalline product
- Molecular Formula: C4H11NO3
- Molecular Weight: 121.14 g/mol.
- CAS Number: 77-86-1
- There are no known major food allergens (as defined by FDA and WHO) in the manufacture of this product.
- BioSpectra certifies that all Tromethamine TRIS-3255 manufactured at BioSpectra and its raw materials are not derived from or come in contact with animal parts, products and/or byproducts. Tromethamine manufactured at BioSpectra and any raw materials used in the manufacture of Tromethamine at BioSpectra are not subject to genetic modification.
- Synonyms: Tris, Tromethamine, Tris(hydroxymethyl)aminomethane
Product Statements:
Plant or Animal Origin Statement: BioSpectra certifies that Tris, Product Code TRIS-3255, manufactured by BioSpectra is of Synthetic origin. BioSpectra certifies that Tris, Product Code TRIS-3255, is not derived from Plant or Animal Origin.
Metal Residue Statement: BioSpectra certifies that Tris, Product Code TRIS-3255, manufactured by BioSpectra is manufactured without the use of metal catalysts and metal reagents. There are no known risks to metal residues in this product.
Melamine Statement: Based on the manufacturing process and the controlled handling, storage, and analysis of Tris, Product Code
TRIS-3255, BioSpectra certifies that there is low risk for melamine contamination. Additionally, when tested for melamine, this product reports less than 0.15 ppm.
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.
GMP Compliance:
Bio Excipient Grade Tromethamine Multicompendial TRIS-3255 is suitable for use as an excipient. It is manufactured in accordance with the ICH-Q7 Good Manufacturing Practice Guide. This grade of Tromethamine Multicompendial is not suitable to be used as an Active Pharmaceutical Ingredient, Drug Product or Household Item.
Reset Date:
The recommended retest period for Tromethamine 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:
10 kg and 25 kg pails and 50 kg drums
Additional Packaging Information
https://www.biospectra.us/technical/packaging