Scapex Exports Pvt. Ltd.
830, 8th Floor, Sun Gravitas, Times of India Road,
Shyamal, Ahmedabad 380015, Gujarat, India
+91 9925522674 · info@scapexexports.com
CIN U46909GJ2025PTC164345
Shyamal, Ahmedabad 380015, Gujarat, India
+91 9925522674 · info@scapexexports.com
CIN U46909GJ2025PTC164345
Certificate of AnalysisStandard product specification
Tris Buffer (Tromethamine)
CAS 77-86-1 · C4H11NO3 · ≥99.8% Biotech/USP
Structural formula1. Product identity
| Product name | Tris Buffer (Tromethamine) |
|---|---|
| C.A.S. number | 77-86-1 |
| Molecular formula | C4H11NO3 |
| Molecular weight | 121.14 g/mol |
| Grade / standard | ≥99.8% Biotech/USP |
| Description | White crystalline powder |
| Product group | Biological Buffers |
| Category | Laboratory & Analytical Reagents |
| Country of origin | India |
| Packing | Bags, drums, carboys, IBC or ISO tank as applicable — customer-specified packing available |
| Storage | Cool, dry, well-ventilated place in tightly closed original packing |
2. Analytical specification
| S. No. | Test parameter | Specification | Typical result | Method |
|---|---|---|---|---|
| 1 | Description | White crystalline powder | Complies | Visual |
| 2 | Identification (A) — Infrared absorption | Concordant with reference spectrum | Complies | IR Spectrophotometry |
| 3 | Identification (B) — Chemical / chromatographic | Positive for the substance | Complies | As per monograph |
| 4 | Solubility | As per specification | Complies | Visual / Monograph |
| 5 | Assay | Not less than 99.8 % w/w | 99.90 | HPLC / Titrimetry (Monograph) |
| 6 | Matter Insoluble in Water | Not more than 0.01 % w/w | 0.0038 | Gravimetry |
| 7 | pH (5 % aqueous solution) | As per specification | 9.6 | Potentiometry |
| 8 | Chloride (Cl) | Not more than 0.001 % | 0.00023 | Turbidimetry |
| 9 | Sulphate (SO4) | Not more than 0.002 % | 0.00033 | Turbidimetry |
| 10 | Iron (Fe) | Not more than 5 ppm | 1.37 ppm | ICP-OES |
| 11 | Heavy Metals (as Pb) | Not more than 5 ppm | Less than 2 ppm | ICP-OES |
| 12 | Loss on Drying | Not more than 1.0 % w/w | 0.18 | Gravimetry (Monograph) |
| 13 | Sulphated Ash / Residue on Ignition | Not more than 0.1 % w/w | 0.036 | Gravimetry (Monograph) |
| 14 | Related Substances — any individual impurity | Not more than 0.10 % | 0.011 | HPLC |
| 15 | Related Substances — total impurities | Not more than 0.50 % | 0.170 | HPLC |
| 16 | Residual Solvents | Complies with ICH Q3C limits | Complies | Headspace GC |
3. Declaration
This document sets out the standard specification for Tris Buffer (Tromethamine) and applies to all consignments of this product and grade supplied by Scapex Exports Pvt. Ltd. It is not a lot-specific release document; a lot-specific certificate carrying the analysis of the material actually shipped is issued with, and travels with, each consignment. Scapex Exports supplies against customer-specified assay limits and pharmacopoeial standards — send your specification sheet and we confirm compliance in writing before the order is accepted.
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