Tromethamine (Tris) - LBLE Active
BIO ACTIVE LBLE GRADE | TR2250 | CAS# 77-86-1
INTENDED FOR USE AS AN ACTIVE PHARMACEUTICAL INGREDIENT
BIO ACTIVE LBLE GRADE | TR2250
CAS #: 77-86-1
Molecular Formula:
C4H11NO3
Solubility in Water @ 25°C (g/L): 550
F.W.: 121.14 g/mol
pH @ 20°C (5% aq. Soln.): 10.0 - 11.5
Useful pH: 7.0 - 9.0
pKa @ 20˚C: 8.3
Bio Active LBLE Grade of Tromethamine is intended to be used in parenteral drug formulations as an Active Pharmaceutical Ingredient. This product is not to be considered sterile and requires further terminal sterilization.
These are general specifications. BioSpectra will customize our products to meet your quality based requirements.
- Spec Sheet
- Compliance
- C of As
- SDS
- Quick Inquiry
| ANALYSIS | SPECIFICATIONS | ||||||||||||||||||||||||
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0.2 a.u. max. | ||||||||||||||||||||||||
| Appearance and Color | White / Crystals | ||||||||||||||||||||||||
| Assay | 99.0-101.0% | ||||||||||||||||||||||||
| Bacterial Endotoxins | 3.0 EU/g max. | ||||||||||||||||||||||||
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| Heavy Metals (as Pb) | 0.5 ppm max. | ||||||||||||||||||||||||
| Identification B | Passes Test | ||||||||||||||||||||||||
| Identification C | Passes Test | ||||||||||||||||||||||||
| Identification (IR) | Passes Test | ||||||||||||||||||||||||
| Insoluble Matter | 0.005% max. | ||||||||||||||||||||||||
| Karl Fischer Water | 2% max. | ||||||||||||||||||||||||
| LOD | 1.0% max. | ||||||||||||||||||||||||
| Melting Range |
168-172 ºC |
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| pH (1 in 20) |
10.0-11.5 |
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≤ 300 ppm ≤ 15 ppm |
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| Residue on Ignition |
0.1% max. |
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| Key Compliance Attributes of BioSpectra Grades | Bio Active Grade ICH Q7 Compliant Manufactured | ||
|---|---|---|---|
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Yes | ||
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Yes | ||
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Yes | ||
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Yes | ||
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Yes | ||
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Yes | ||
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Yes | ||
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Yes | ||
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Yes | ||
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Yes | ||
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Yes | ||
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Yes | ||
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Yes | ||
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Yes | ||
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Yes | ||
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Yes | ||
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Yes | ||
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Yes | ||
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Yes | ||
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Yes | ||
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Yes | ||
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Yes | ||
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N/A | ||
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Yes | ||
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Yes | ||
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Yes | ||
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Yes | ||
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Yes | ||
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Yes | ||
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Available |
| List of C of As files |
|---|
| TR2250-001-0519.pdf |
| TR2250-002-0519.pdf |
| TR2250-003-0519.pdf |
General Product Description:
- The Manufacturing of LBLE Active Grade Tromethamine TR2250 is performed at BioSpectra’s Bangor, PA facility utilizing multiuse equipment. Equipment used in the manufacturing of LBLE Active Grade Tromethamine TR2250 is cleaned in accordance with BioSpectra’s Cleaning Validation Plan.
- Tromethamine is a White Crystalline product.
- Molecular Formula: NH2C(CH2OH)3
- 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 TR2250 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.
GMP Compliance:
Bio LBLE Active Grade Tromethamine TR2250 is manufactured in
accordance with ICH Q7 cGMP guidelines including sections 4.34
& 12.75 and is suitable to be used only as the following: non-
Sterile ICH Q7 compliant Active Pharmaceutical Ingredient for use
in further processing to produce a Sterile Drug Product. This grade
of Tromethamine is not suitable to be used as a sterile Active
Pharmaceutical Ingredient, Drug Product or Household Item.
Expiration/Retest Date:
The recommended retest period for Tromethamine is two years
from the date of manufacture.
Storage and Shipping Conditions:
- Store in a clean and dry area.
- Store in the original container.
Package Sizes:
10kg, 25kg and 50kg pails.